Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.

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BACKGROUND: Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer. MATERIAL AND METHODS Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days. RESULTS Five hundred and sixty-four patients were included in the study. TO was achieved in 49.8%. The sample had a mean age of 69 ± 11 years, and 60% were male. Female sex (OR 1.61; 95% CI 2.30-1.13), T3 and T4 classification (OR 2.50, 95% CI 4.59-1.36, and OR 2.55, 95% CI 5.21-1.24 respectively) and laparoscopic approach (OR 1.53, 95% CI 2.33-1.00) were independent factors that were significantly associated with achieving a TO. Patients who achieved TO had higher overall survival (p=0.008) than those who did not. However, with regard to disease-free survival, no statistically significant differences were found (p=0.303). CONCLUSION TO is a useful, easy-to-interpret management tool for measuring oncological results and for predicting patient survival. The study was registered in the public accessible database clinicaltrials.gov with the ClinicalTrials.gov ID: NCT05675904. Public release date: 01/05/2023.
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J.J Rubio-García, Francisco Mauri Barberá, Celia Villodre Tudela, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2481273/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 May, 2023 Read the published version in Langenbeck's Archives of Surgery → Version 1 posted 11 You are reading this latest preprint version Abstract BACKGROUND: Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer. MATERIAL AND METHODS : Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days. RESULTS : Five hundred and sixty-four patients were included in the study. TO was achieved in 49.8%. The sample had a mean age of 69 ± 11 years, and 60% were male. Female sex (OR 1.61; 95% CI 2.30-1.13), T3 and T4 classification (OR 2.50, 95% CI 4.59-1.36, and OR 2.55, 95% CI 5.21-1.24 respectively) and laparoscopic approach (OR 1.53, 95% CI 2.33-1.00) were independent factors that were significantly associated with achieving a TO. Patients who achieved TO had higher overall survival (p=0.008) than those who did not. However, with regard to disease-free survival, no statistically significant differences were found (p=0.303). CONCLUSION : TO is a useful, easy-to-interpret management tool for measuring oncological results and for predicting patient survival. The study was registered in the public accessible database clinicaltrials.gov with the ClinicalTrials.gov ID: NCT05675904. Public release date: 01/05/2023. Textbook outcome colon cancer colon carcinoma Figures Figure 1 Figure 2 1. Introduction The continuous improvement of the quality of care is one of the main objectives of clinical management. For ethical, social, safety and economic reasons, it is important to identify processes that are currently achieving suboptimal results and to find ways of refining or redesigning them [ 1 ]. A wide range of indices are available for assessing quality of care. Among them, in 2013 Kolfschoten et al. [ 2 ] characterized the concept of “textbook outcome” (TO) as a measurement tool, defined as the proportion of patients undergoing resection for colon cancer who obtained all the expected health results. TO is a single indicator that uses a set of traditional surgical measures, among them mortality, postoperative complications, hospital stay and readmission rate. Although initially described in colorectal surgery, in recent years the use of TO has expanded to other settings such as bariatric surgery and hepatobiliary-pancreatic, esophagogastric or peritoneal carcinomatosis surgery. [ 3 – 5 ]. Attempts have been made to define TO according to specific pathologies in order to standardize the concept and the indicators included in each setting. TO is not just a valuable management tool; it can also produce an internal audit of surgical results and provides a benchmark for comparisons with other surgical services. It may also help to guide patients’ decision-making processes when choosing between health services [ 6 ]. The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. We assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization. 2. Material And Methods 2.1. Study setting and patient identification The study was authorized by the Ethics Committee (CEIM) of the public Hospital General Universitario de Alicante (HGUA: nº 2022 − 103, ISABIAL 2022 − 0297). This retrospective, observational study was conducted between September 2012 and August 2016. The requirement of informed consent was waived due to the retrospective design and the absence of any risk. No information that might identify individual patients was used. Data on patients who underwent resection for colon cancer during the study period were extracted from the hospital’s database and analysed retrospectively. The study was designed and conducted in accordance with the STROBE guidelines [ 7 ]. 2.2. PATIENT SELECTION AND DATA COLLECTION. Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study. Exclusion criteria were age under 18 years, emergency surgery, resections of the rectum or resections for pathologies other than cancer, and follow-up of less than two years (with the exception of patients who died). The variables were recorded after analysing the digitized medical records and ensuring a follow-up according to protocol for a minimum of two years or until death. The decision to operate was made after assessment of each case by a multidisciplinary committee comprising gastroenterologists, surgeons, oncologists, radiologists and pathologists. The demographic variables included were age and sex. Tumor diagnosis included tumor location and the TNM classification according to the eighth edition of the American Joint Committee on Cancer (AJCC) [ 8 ], including the number of nodes isolated and R0 resections. Surgical variables included the type of anatomical resection performed (right hemicolectomy, left hemicolectomy, extended right hemicolectomy, sigmoidectomy, and total colectomy), the approach (open or laparoscopic), whether a stoma was created (ileostomy or colostomy), either during elective surgery or during emergency surgery due to the appearance of complications after the initial intervention. The postoperative variables assessed included total hospital stay, the appearance of complications according to the Clavien-Dindo classification [ 9 ], 30-day readmission rate, 30-day mortality, overall survival, and disease-free survival. 2.3. DEFINITIONS. After reviewing the principal studies of colon cancer resection from the perspective of TO [ 2 , 10 , 11 ], we included the following indicators in our definition of the concept: radical resection, acceptable number of isolated lymph nodes, no complications, no prolonged hospital stay and no readmissions or mortality associated with the procedure. The indicators for achieving TO were defined as follows: Radical resection: a R0 resection with surgical margins without macroscopic or microscopic tumor involvement Number of lymph nodes isolated: a figure below 12 was taken to be adequate for staging, in accordance with the AJCC guidelines [ 8 ]. Complications: Clavien-Dindo score ≥ III during the first 30 days. Hospital stay: below 14 days, taken as a reference value in the literature after analysing the 75th percentile [ 2 ]. Finally, no readmission or mortality in the first 30 days. Patients who met all these conditions were taken as presenting a TO. 2.4. STATISTICAL ANALYSIS. Statistical analysis was performed with IBM-SPSS 25.0 ®. The quantitative variables were expressed as measures of central tendency with means and medians, together with dispersion measures such as standard deviation and statistical range. The qualitative variables were expressed in the form of proportions or percentages. To compare quantitative variables, the Mann-Whitney U test was applied since none of the variables had a normal distribution. Then, multilevel mixed-effects logistic regression analysis was performed. Kaplan-Meier model survival curves were used to establish the relationship between TO and overall and disease-free survival. In both survival analyses, the Log Rank statistical test was used to contrast the survival functions of the two groups. We performed Cox regression as a proportional hazards model to establish the risks that affect overall survival, taking into account whether or not a TO was obtained. Results with “p” levels of < 0.05 were considered statistically significant. 3. Results Five hundred and sixty-four patients who had undergone elective colon cancer resection were included in the study. The mean age of the sample was 68.8 years (range 36–93; σ = 10.9). Male patients predominated, accounting for 59.6% of the total. The most frequent preoperative diagnosis and location was ascending colon cancer in 240 cases (42.5%), followed by sigmoid colon in 213 (37.7%), descending colon in 63 cases (11.2%), transverse colon in 26 (4.6%) and colonic polyposis or several tumors in different segments in 22 (3.9%). The most frequently performed surgical procedures were right hemicolectomy in 221 patients (39.1%), sigmoidectomy in 210 (37.2%) and left hemicolectomy in 62 (11%). The approach was open in 413 cases (73.2%) and laparoscopic in 151 (26.8%). A total of 281 patients (49.8%) obtained a TO. Analysing each of the indicators included in the definition of TO individually, 90.8% of patients presented R0 resection, 78.1% had 12 or fewer nodes isolated, and 78.6% had a hospital stay < 14 days. A Clavien-Dindo complication score ≥ IIIa was recorded in 24.6%, the most frequent complications being postoperative intra-abdominal collection (21 patients), evisceration (20 patients) or anastomotic leak (46 patients). The 30-day hospital readmission rate was 11.7% and the 30-day mortality rate 4.3%. Figure 1 shows the graph with the percentage of compliance with each of the indicators and the cumulative percentage of patients who achieved TO. Table 1 compares the characteristics of the sample depending on whether or not they obtained TO. The proportion of females in the TO group was significantly higher than in the non-TO group (47% vs 33.9%; p = 0.002); there were no differences according to age. The pT classification also showed differences between the groups, with a significantly higher proportion of T3 (55.5% vs. 45.2%) and T4 (17.8% vs. 15.9%) in the TO than in the non-TO group (P = 0.005). However, there were no differences in terms of lymph node involvement or metastasis. The laparoscopic approach was also more frequent (30.6% vs 23%, P = 0.046) in TO patients. Table 2 presents the univariate analysis comparing cohorts of patients with and without TO with regard to the main variables. Significant associations were found with female sex, tumor location, T stage and surgical approach. Table 3 presents the multivariate logistic regression. Female gender was identified as an independent factor for obtaining a TO, with a significantly higher rate than in males (OR 1.61, 95% CI 2.30–1.13). Other independent factors were T3 and T4 tumor stages (OR 2.50, 95% CI 4.59–1.36 and OR 2.55, 95% CI 5.21–1.24 respectively) and the laparoscopic approach versus the open approach (OR 1.53, 95% CI 2.33-1.00). Both overall and disease-free survival were significantly higher in patients with TO [overall survival 76.9 vs. 65.6 months (P = 0.003), and disease-free survival 62.5 vs. 59.5 months (P = 0.031)] as displayed in Table 1 . Figure 2 A shows the higher overall survival rates in the Kaplan-Meier analysis of TO vs. non-TO patients, with significant differences in the Log rank test (P = 0.008). The multivariate Cox proportional hazards model identified age (HR 1.04, 95% CI 1.06–1.03 per year), laparoscopic approach (HR 0.59, 95% CI 0.82 − 0.43), T1 and T3 classification (HR 0.35, CI 95% 0.67 − 0.19 and HR 0.51, 95% CI 0.80 − 0.32 respectively), lymph node involvement (HR 1.43, 95% CI 1.86–1.10) and metastasis (HR 4.36, 95% CI 6.20–3.06) as independent factors for mortality. For its part, the Kaplan-Meier analysis indicates a trend in the group with TO towards longer disease-free survival (Fig. 2 b), although the differences were not significant (P = 0.303). 4. Discussion This study has shown TO to be a useful quality indicator in patients who have undergone colon cancer resection, and underlines its value as a management and internal audit tool. It can also be used in strategies such as benchmarking to compare similar procedures at different services, or to predict survival. At our unit, TO was achieved in 49.8% of patients. TO is obtained by combining several traditional surgical variables such as mortality, postoperative complications [using the Clavien-Dindo classification or the Comprehensive Complication Index (CCI ©)], hospital stay, and readmission rate [ 12 ]. It is designed to represent an optimal surgical result [ 4 ]. On the other hand, it does not provide a reliable reflection of the patient’s opinion of a surgical intervention, since this opinion is not “all or nothing” as the indicator reflects. As TO is created by adding together a number of surgical measures, its applicability would be increased by the establishment of an expert consensus to standardize the measures for each specific area [ 6 ]. For example, the study by Busweiler et al. provided an international definition of the indicators included in esophagogastric surgery [ 4 , 13 ]. In the case of colorectal cancer surgery, no such consensus currently exists and so no comparisons can be made between the results of different centers. To date, only five studies have analysed patients undergoing elective surgery for colon cancer from the perspective of TO. Most of these studies have assessed data from national databases, with rates of TO reported ranging from 49–66.9% [ 2 , 10 , 14 – 16 ], similar to the figure obtained in our study. However, the indicators included in the definition of TO in this setting vary widely. While the original study by Kolfschoten [ 2 ] used the variables hospital survival, radical resection, no reintervention, no ostomy, no adverse effects, and no prolonged hospital stay, the other studies also include variables related either to an ideal oncological result – i.e., R0 resections, an acceptable number of lymph nodes isolated or adequate adjuvant treatment – or to diagnostic procedures or morbidity and mortality – i.e., pre- or postoperative colonoscopy, surgery < 6 weeks after diagnosis, and mortality or readmission in the early postoperative period [ 10 , 14 , 15 , 17 ]. In this study certain factors that were shown to be associated with the likelihood of obtaining a TO, such as sex, surgical approach and T stage. However, as other studies have shown, the likelihood of obtaining a TO is multifactorial: patient-dependent factors such as comorbidity and frailty and other factors such as the type of hospital and the experience of the surgical team should also be borne in mind [ 10 , 18 ]. Mainly because of the heterogeneity of the definition of TO used, we found that studies that do not include postoperative complications (or do not clearly characterize what they understand by complications) obtain higher rates of TO (Sweigert et al.: 54.8%, Aquina et al.: 66.9%, and Yang et al.: 59.5%) [ 10 , 14 , 16 ]. The main reason for this is that the presence of indicators such as hospital stay and readmission rate is related to the likelihood of having postoperative complications. In this study we include complications, since it is the only way to avoid information bias, and consider them as a fundamental factor in the patients’ perceptions of post-surgical evolution [ 19 ]. The inclusion of complications adds important postoperative information and allows a fuller definition of TO, incorporating the patient’s point of view as well as the clinical perspective. As we have shown, defining TO not only allows evaluation and monitoring of surgical results, but can also predict survival. In agreement with Yang et al [ 14 ] we found an association between TO and increased survival, together with a trend towards higher disease-free survival. In addition, the use of TO has highlighted important differences between patients according to their vulnerability [ 15 ] and also between hospitals [ 20 , 21 ] and has been reported to reduce costs [ 22 ]. As regards surgical approach, better results were achieved with laparoscopy than with open surgery. Although this finding may be due to a bias (namely, that less complex patients are selected for laparoscopy), other research has found higher rates of TO using a minimally invasive approach [ 23 ]. Therefore, this indicator should be assessed along with survival, clinical results, quality of life and costs to the health system in the definitions of TO for specific pathologies [ 24 ]. TO was significantly associated with T3 and T4 tumor stages. It is likely that this relationship is influenced by characteristics such as comorbidity, which was not included in the study design but may act as a confounding factor in its analysis. Thus, we believe that future studies of TO should include other factors such as comorbidities, frailty, risk of malnutrition, and other physiological variables such as preoperative hemoglobin. In a study using the US National Cancer Database, Aquina et al. [ 16 ] analysed a total of 852,988 patients undergoing high-risk cancer surgeries such as gastric, pancreas, colon, rectum, lung, esophagus and ovary resections. Those authors concluded that TO can be used to compare care quality at different cancer centers. On the other hand, expert opinions such as the article by Auer and Balaa [ 17 ] question its use in interhospital comparisons given the possible tendency to select patients likely to achieve better clinical results and thus limit the inclusion of high-risk patients. In his initial description, Kolfschoten [ 2 ] applied TO in low-risk patients, but as the use of the concept has spread to other settings, patients of all degrees of severity have been included. In our study, for example, no patients were excluded during the risk stratification process. The main limitation of this study is its retrospective nature. The information available in the digitized medical records, differences in follow-up or intraoperative technical differences may have significantly increased the risk of bias. The main interest of the study is the novelty of the indicator used. Other strengths are the large sample size, the inclusion of both low- and high-risk patients, and the fact that few studies to date have analysed colon cancer resections from this perspective. 5. Conclusion This study shows that textbook outcome is a valuable multidimensional quality management tool for assessing oncological results in colon cancer resection. From the patient's point of view, TO is easy to interpret, since it represents the ideal surgical course. An international consensus now needs to be established that can help to standardize the definition of TO in this specific area, and thus allow objective interhospital comparisons to be made. The association of TO and survival gives it a significant predictive value. Overall, it is a valuable benchmark for evaluating the quality of gastrointestinal cancer surgery and may be particularly useful in clinical research and in programs designed to improve quality of care in cancer treatment. Declarations STATEMENTS AND DECLARATIONS: Authors declare no competing interests. Authors declare no funding. Conflict of Interest: The authors declare that they have no conflict of interest. The study was authorized by the Ethics Committee (CEIM) of the public Hospital General Universitario de Alicante (HGUA: nº 2022-103, ISABIAL 2022-0297). The requirement of informed consent was waived due to the retrospective design and the absence of any risk. No information that might identify individual patients was used. References Cabadas Avión R. La calidad asistencial: ¿de qué estamos hablando? Quality Care: What are we speaking about? FORMACIÓN CONTINUADA. CIR MAY AMB 2015. 2015;20(2):79–82. Available from: www.asecma.org Kolfschoten NE, Kievit J, Gooiker GA, Van Leersum NJ, Snijders HS, Eddes EH, et al. Focusing on desired outcomes of care after colon cancer resections; hospital variations in “textbook outcome.” Eur J Surg Oncol. 2013 Feb;39(2):156–63. 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Available from: https://link.springer.com/article/ 10.1007/s00268-020-05625-9 Priego P, Cuadrado M, Ballestero A, Galindo J, Lobo E. Comparison of Laparoscopic Versus Open Gastrectomy for Treatment of Gastric Cancer: Analysis of a Textbook Outcome. https://home.liebertpub.com/lap . 2019 Apr 10;29(4):458–64. Available from: https://www.liebertpub.com/doi/ 10.1089/lap.2018.0489 Fong Y. Textbook Outcome Nomograms as Multivariate Clinical Tools for Building Cancer Treatment Pathways and Prognosticating Outcomes. JAMA Surg. 2019 Jun;154(6):e190572–e190572. Available from: https://jamanetwork.com/journals/jamasurgery/fullarticle/2731304 Tables Tables 1-3 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table13.docx Cite Share Download PDF Status: Published Journal Publication published 30 May, 2023 Read the published version in Langenbeck's Archives of Surgery → Version 1 posted Editorial decision: Major revision 09 Apr, 2023 Reviews received at journal 24 Mar, 2023 Reviewers agreed at journal 13 Mar, 2023 Reviews received at journal 18 Feb, 2023 Reviewers agreed at journal 05 Feb, 2023 Reviewers agreed at journal 02 Feb, 2023 Reviewers agreed at journal 01 Feb, 2023 Reviewers invited by journal 01 Feb, 2023 Editor assigned by journal 18 Jan, 2023 Submission checks completed at journal 18 Jan, 2023 First submitted to journal 15 Jan, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-2481273","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":168680960,"identity":"de4ecb29-dc37-40eb-a0bb-e1a3624b9090","order_by":0,"name":"J.J Rubio-García","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+klEQVRIiWNgGAWjYBACxgYgIQFiMTM2HEioADGYG4jUws588MCHMxC9RNrHz5Z8cGYb3BjcgHlG8rMHFhV1ifObeQwO886rjeZvB2r5UbENt8NmpJkbSJw5nLjhMEjLtuO5Mw4zNjD2nLmNR0uCmYRk24HEDcxgLcdyG4BamBnb8GlJ/yYh+Q/msDnHcucT1pIDtKWBObHhMFvCwZkNNbkbCGrpeVMmIXHssPGGw8wHDnw4diB3I1DLQXx+MWxP3yYtUVMnO7//YPOHhJq63HnnDx988KMCj5YGYEBLIPiHweQBnOqBQB7kuA8Ifh0+xaNgFIyCUTBCAQB9gGGorYJnQQAAAABJRU5ErkJggg==","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"J.J","middleName":"","lastName":"Rubio-García","suffix":""},{"id":168680961,"identity":"42accb30-e862-4e29-acc6-acb5e0fa3216","order_by":1,"name":"Francisco Mauri Barberá","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Francisco","middleName":"Mauri","lastName":"Barberá","suffix":""},{"id":168680963,"identity":"cf8d5c36-2923-474d-96e4-27cbf53e7104","order_by":2,"name":"Celia Villodre Tudela","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Celia","middleName":"Villodre","lastName":"Tudela","suffix":""},{"id":168680964,"identity":"75e8f250-3874-4fb0-b967-9f88b641156e","order_by":3,"name":"Silvia Carbonell Morote","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Silvia","middleName":"Carbonell","lastName":"Morote","suffix":""},{"id":168680965,"identity":"65884d81-7c8e-41c0-8fda-6d8008768350","order_by":4,"name":"Ana Isabel Fábregues Olea","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Ana","middleName":"Isabel Fábregues","lastName":"Olea","suffix":""},{"id":168680966,"identity":"c6673627-5641-45f5-946f-6994d0c67404","order_by":5,"name":"Cándido Alcázar López","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Cándido","middleName":"Alcázar","lastName":"López","suffix":""},{"id":168680967,"identity":"9a3ff86f-895f-4adb-b73f-38617aa1757b","order_by":6,"name":"Clara Llopis Torremocha","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Clara","middleName":"Llopis","lastName":"Torremocha","suffix":""},{"id":168680969,"identity":"51eb0de1-5ba6-4d13-ad30-9bc693e22e12","order_by":7,"name":"Joaquín Ruiz López","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Joaquín","middleName":"Ruiz","lastName":"López","suffix":""},{"id":168680970,"identity":"2128b3d3-0bb6-4d17-adf5-7994de124c2c","order_by":8,"name":"Álvaro Gomis Martín","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Álvaro","middleName":"Gomis","lastName":"Martín","suffix":""},{"id":168680972,"identity":"02a55181-c33f-48cc-b958-8039caa4c395","order_by":9,"name":"Manuel Romero Simo","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Manuel","middleName":"Romero","lastName":"Simo","suffix":""},{"id":168680973,"identity":"899429ba-c3dd-4cca-a98b-9204eb7f3c92","order_by":10,"name":"José Manuel Ramia-Ángel","email":"","orcid":"","institution":"Hospital General Universitario de Alicante","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"José","middleName":"Manuel","lastName":"Ramia-Ángel","suffix":""}],"badges":[],"createdAt":"2023-01-15 17:44:11","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-2481273/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-2481273/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00423-023-02949-7","type":"published","date":"2023-05-30T21:03:20+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":31883239,"identity":"4991a141-9a12-4644-a807-a19adfcc7a91","added_by":"auto","created_at":"2023-01-20 22:13:45","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":12422,"visible":true,"origin":"","legend":"\u003cp\u003eBar chart with the percentage of compliance with each of the indicators and the cumulative percentage of patients who achieved TO.\u003c/p\u003e","description":"","filename":"F1.png","url":"https://assets-eu.researchsquare.com/files/rs-2481273/v1/94d1342f70a47279f474599b.png"},{"id":31884680,"identity":"ff61d275-b0e6-46a7-ad59-baa641a4c14d","added_by":"auto","created_at":"2023-01-20 22:29:45","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":64381,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eA. \u003c/strong\u003eOverall survival rates in the Kaplan-Meier analysis of TO vs. non-TO patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eB. \u003c/strong\u003eDisease-free survival rates in the Kaplan-Meier analysis of TO vs. non-TO patients.\u003c/p\u003e","description":"","filename":"F2.png","url":"https://assets-eu.researchsquare.com/files/rs-2481273/v1/a30860e87100cdac8280364f.png"},{"id":44730855,"identity":"60b85f1c-cd3f-4f7c-8099-cd80e590d466","added_by":"auto","created_at":"2023-10-16 21:34:52","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":349723,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2481273/v1/5f823b59-106a-44b2-a05e-5e7ccabe002e.pdf"},{"id":31884245,"identity":"743e8e8e-8718-4285-908a-da10e6050c6b","added_by":"auto","created_at":"2023-01-20 22:21:45","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":198027,"visible":true,"origin":"","legend":"","description":"","filename":"Table13.docx","url":"https://assets-eu.researchsquare.com/files/rs-2481273/v1/83de5c65f03201982c820a77.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eTextbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.\u003c/p\u003e","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eThe continuous improvement of the quality of care is one of the main objectives of clinical management. For ethical, social, safety and economic reasons, it is important to identify processes that are currently achieving suboptimal results and to find ways of refining or redesigning them [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA wide range of indices are available for assessing quality of care. Among them, in 2013 Kolfschoten et al. [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] characterized the concept of \u0026ldquo;textbook outcome\u0026rdquo; (TO) as a measurement tool, defined as the proportion of patients undergoing resection for colon cancer who obtained all the expected health results. TO is a single indicator that uses a set of traditional surgical measures, among them mortality, postoperative complications, hospital stay and readmission rate.\u003c/p\u003e \u003cp\u003eAlthough initially described in colorectal surgery, in recent years the use of TO has expanded to other settings such as bariatric surgery and hepatobiliary-pancreatic, esophagogastric or peritoneal carcinomatosis surgery. [\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Attempts have been made to define TO according to specific pathologies in order to standardize the concept and the indicators included in each setting.\u003c/p\u003e \u003cp\u003eTO is not just a valuable management tool; it can also produce an internal audit of surgical results and provides a benchmark for comparisons with other surgical services. It may also help to guide patients\u0026rsquo; decision-making processes when choosing between health services [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. We assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.\u003c/p\u003e"},{"header":"2. Material And Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1. Study setting and patient identification\u003c/h2\u003e \u003cp\u003e The study was authorized by the Ethics Committee (CEIM) of the public Hospital General Universitario de Alicante (HGUA: n\u0026ordm; 2022\u0026thinsp;\u0026minus;\u0026thinsp;103, ISABIAL 2022\u0026thinsp;\u0026minus;\u0026thinsp;0297). This retrospective, observational study was conducted between September 2012 and August 2016. The requirement of informed consent was waived due to the retrospective design and the absence of any risk. No information that might identify individual patients was used. Data on patients who underwent resection for colon cancer during the study period were extracted from the hospital\u0026rsquo;s database and analysed retrospectively. The study was designed and conducted in accordance with the STROBE guidelines [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2. PATIENT SELECTION AND DATA COLLECTION.\u003c/h2\u003e \u003cp\u003ePatients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study. Exclusion criteria were age under 18 years, emergency surgery, resections of the rectum or resections for pathologies other than cancer, and follow-up of less than two years (with the exception of patients who died).\u003c/p\u003e \u003cp\u003eThe variables were recorded after analysing the digitized medical records and ensuring a follow-up according to protocol for a minimum of two years or until death. The decision to operate was made after assessment of each case by a multidisciplinary committee comprising gastroenterologists, surgeons, oncologists, radiologists and pathologists.\u003c/p\u003e \u003cp\u003eThe demographic variables included were age and sex. Tumor diagnosis included tumor location and the TNM classification according to the eighth edition of the American Joint Committee on Cancer (AJCC) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e], including the number of nodes isolated and R0 resections. Surgical variables included the type of anatomical resection performed (right hemicolectomy, left hemicolectomy, extended right hemicolectomy, sigmoidectomy, and total colectomy), the approach (open or laparoscopic), whether a stoma was created (ileostomy or colostomy), either during elective surgery or during emergency surgery due to the appearance of complications after the initial intervention. The postoperative variables assessed included total hospital stay, the appearance of complications according to the Clavien-Dindo classification [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], 30-day readmission rate, 30-day mortality, overall survival, and disease-free survival.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3. DEFINITIONS.\u003c/h2\u003e \u003cp\u003eAfter reviewing the principal studies of colon cancer resection from the perspective of TO [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], we included the following indicators in our definition of the concept: radical resection, acceptable number of isolated lymph nodes, no complications, no prolonged hospital stay and no readmissions or mortality associated with the procedure.\u003c/p\u003e \u003cp\u003eThe indicators for achieving TO were defined as follows:\u003c/p\u003e \u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eRadical resection: a R0 resection with surgical margins without macroscopic or microscopic tumor involvement\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eNumber of lymph nodes isolated: a figure below 12 was taken to be adequate for staging, in accordance with the AJCC guidelines [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eComplications: Clavien-Dindo score\u0026thinsp;\u0026ge;\u0026thinsp;III during the first 30 days.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eHospital stay: below 14 days, taken as a reference value in the literature after analysing the 75th percentile [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eFinally, no readmission or mortality in the first 30 days.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e \u003cp\u003ePatients who met all these conditions were taken as presenting a TO.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.4. STATISTICAL ANALYSIS.\u003c/h2\u003e \u003cp\u003eStatistical analysis was performed with IBM-SPSS 25.0 \u0026reg;. The quantitative variables were expressed as measures of central tendency with means and medians, together with dispersion measures such as standard deviation and statistical range. The qualitative variables were expressed in the form of proportions or percentages. To compare quantitative variables, the Mann-Whitney U test was applied since none of the variables had a normal distribution. Then, multilevel mixed-effects logistic regression analysis was performed.\u003c/p\u003e \u003cp\u003eKaplan-Meier model survival curves were used to establish the relationship between TO and overall and disease-free survival. In both survival analyses, the Log Rank statistical test was used to contrast the survival functions of the two groups. We performed Cox regression as a proportional hazards model to establish the risks that affect overall survival, taking into account whether or not a TO was obtained. Results with \u0026ldquo;p\u0026rdquo; levels of \u0026lt;\u0026thinsp;0.05 were considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv\u003e\n \u003cp\u003eFive hundred and sixty-four patients who had undergone elective colon cancer resection were included in the study. The mean age of the sample was 68.8 years (range 36\u0026ndash;93; \u0026sigma;\u0026thinsp;=\u0026thinsp;10.9). Male patients predominated, accounting for 59.6% of the total.\u003c/p\u003e\n \u003cp\u003eThe most frequent preoperative diagnosis and location was ascending colon cancer in 240 cases (42.5%), followed by sigmoid colon in 213 (37.7%), descending colon in 63 cases (11.2%), transverse colon in 26 (4.6%) and colonic polyposis or several tumors in different segments in 22 (3.9%). The most frequently performed surgical procedures were right hemicolectomy in 221 patients (39.1%), sigmoidectomy in 210 (37.2%) and left hemicolectomy in 62 (11%). The approach was open in 413 cases (73.2%) and laparoscopic in 151 (26.8%).\u003c/p\u003e\n \u003cp\u003eA total of 281 patients (49.8%) obtained a TO. Analysing each of the indicators included in the definition of TO individually, 90.8% of patients presented R0 resection, 78.1% had 12 or fewer nodes isolated, and 78.6% had a hospital stay\u0026thinsp;\u0026lt;\u0026thinsp;14 days. A Clavien-Dindo complication score\u0026thinsp;\u0026ge;\u0026thinsp;IIIa was recorded in 24.6%, the most frequent complications being postoperative intra-abdominal collection (21 patients), evisceration (20 patients) or anastomotic leak (46 patients). The 30-day hospital readmission rate was 11.7% and the 30-day mortality rate 4.3%. Figure \u003cspan\u003e1\u003c/span\u003e shows the graph with the percentage of compliance with each of the indicators and the cumulative percentage of patients who achieved TO.\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eTable \u003cspan\u003e1\u003c/span\u003e compares the characteristics of the sample depending on whether or not they obtained TO. The proportion of females in the TO group was significantly higher than in the non-TO group (47% vs 33.9%; p\u0026thinsp;=\u0026thinsp;0.002); there were no differences according to age. The pT classification also showed differences between the groups, with a significantly higher proportion of T3 (55.5% vs. 45.2%) and T4 (17.8% vs. 15.9%) in the TO than in the non-TO group (P\u0026thinsp;=\u0026thinsp;0.005). However, there were no differences in terms of lymph node involvement or metastasis. The laparoscopic approach was also more frequent (30.6% vs 23%, P\u0026thinsp;=\u0026thinsp;0.046) in TO patients.\u003c/p\u003e\n\u003cp\u003eTable \u003cspan\u003e2\u003c/span\u003e presents the univariate analysis comparing cohorts of patients with and without TO with regard to the main variables. Significant associations were found with female sex, tumor location, T stage and surgical approach. Table \u003cspan\u003e3\u003c/span\u003e presents the multivariate logistic regression. Female gender was identified as an independent factor for obtaining a TO, with a significantly higher rate than in males (OR 1.61, 95% CI 2.30\u0026ndash;1.13). Other independent factors were T3 and T4 tumor stages (OR 2.50, 95% CI 4.59\u0026ndash;1.36 and OR 2.55, 95% CI 5.21\u0026ndash;1.24 respectively) and the laparoscopic approach versus the open approach (OR 1.53, 95% CI 2.33-1.00).\u003c/p\u003e\n\u003cp\u003eBoth overall and disease-free survival were significantly higher in patients with TO [overall survival 76.9 vs. 65.6 months (P\u0026thinsp;=\u0026thinsp;0.003), and disease-free survival 62.5 vs. 59.5 months (P\u0026thinsp;=\u0026thinsp;0.031)] as displayed in Table \u003cspan\u003e1\u003c/span\u003e. Figure \u003cspan\u003e2\u003c/span\u003eA shows the higher overall survival rates in the Kaplan-Meier analysis of TO vs. non-TO patients, with significant differences in the Log rank test (P\u0026thinsp;=\u0026thinsp;0.008). The multivariate Cox proportional hazards model identified age (HR 1.04, 95% CI 1.06\u0026ndash;1.03 per year), laparoscopic approach (HR 0.59, 95% CI 0.82\u0026thinsp;\u0026minus;\u0026thinsp;0.43), T1 and T3 classification (HR 0.35, CI 95% 0.67\u0026thinsp;\u0026minus;\u0026thinsp;0.19 and HR 0.51, 95% CI 0.80\u0026thinsp;\u0026minus;\u0026thinsp;0.32 respectively), lymph node involvement (HR 1.43, 95% CI 1.86\u0026ndash;1.10) and metastasis (HR 4.36, 95% CI 6.20\u0026ndash;3.06) as independent factors for mortality. For its part, the Kaplan-Meier analysis indicates a trend in the group with TO towards longer disease-free survival (Fig. \u003cspan\u003e2\u003c/span\u003eb), although the differences were not significant (P\u0026thinsp;=\u0026thinsp;0.303).\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThis study has shown TO to be a useful quality indicator in patients who have undergone colon cancer resection, and underlines its value as a management and internal audit tool. It can also be used in strategies such as benchmarking to compare similar procedures at different services, or to predict survival. At our unit, TO was achieved in 49.8% of patients.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003eTO is obtained by combining several traditional surgical variables such as mortality, postoperative complications [using the Clavien-Dindo classification or the Comprehensive Complication Index (CCI \u0026copy;)], hospital stay, and readmission rate [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. It is designed to represent an optimal surgical result [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. On the other hand, it does not provide a reliable reflection of the patient\u0026rsquo;s opinion of a surgical intervention, since this opinion is not \u0026ldquo;all or nothing\u0026rdquo; as the indicator reflects.\u003c/p\u003e \u003cp\u003eAs TO is created by adding together a number of surgical measures, its applicability would be increased by the establishment of an expert consensus to standardize the measures for each specific area [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. For example, the study by Busweiler et al. provided an international definition of the indicators included in esophagogastric surgery [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. In the case of colorectal cancer surgery, no such consensus currently exists and so no comparisons can be made between the results of different centers.\u003c/p\u003e \u003cp\u003eTo date, only five studies have analysed patients undergoing elective surgery for colon cancer from the perspective of TO. Most of these studies have assessed data from national databases, with rates of TO reported ranging from 49\u0026ndash;66.9% [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], similar to the figure obtained in our study. However, the indicators included in the definition of TO in this setting vary widely. While the original study by Kolfschoten [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] used the variables hospital survival, radical resection, no reintervention, no ostomy, no adverse effects, and no prolonged hospital stay, the other studies also include variables related either to an ideal oncological result \u0026ndash; i.e., R0 resections, an acceptable number of lymph nodes isolated or adequate adjuvant treatment \u0026ndash; or to diagnostic procedures or morbidity and mortality \u0026ndash; i.e., pre- or postoperative colonoscopy, surgery\u0026thinsp;\u0026lt;\u0026thinsp;6 weeks after diagnosis, and mortality or readmission in the early postoperative period [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn this study certain factors that were shown to be associated with the likelihood of obtaining a TO, such as sex, surgical approach and T stage. However, as other studies have shown, the likelihood of obtaining a TO is multifactorial: patient-dependent factors such as comorbidity and frailty and other factors such as the type of hospital and the experience of the surgical team should also be borne in mind [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eMainly because of the heterogeneity of the definition of TO used, we found that studies that do not include postoperative complications (or do not clearly characterize what they understand by complications) obtain higher rates of TO (Sweigert et al.: 54.8%, Aquina et al.: 66.9%, and Yang et al.: 59.5%) [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. The main reason for this is that the presence of indicators such as hospital stay and readmission rate is related to the likelihood of having postoperative complications. In this study we include complications, since it is the only way to avoid information bias, and consider them as a fundamental factor in the patients\u0026rsquo; perceptions of post-surgical evolution [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The inclusion of complications adds important postoperative information and allows a fuller definition of TO, incorporating the patient\u0026rsquo;s point of view as well as the clinical perspective.\u003c/p\u003e \u003cp\u003eAs we have shown, defining TO not only allows evaluation and monitoring of surgical results, but can also predict survival. In agreement with Yang et al [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] we found an association between TO and increased survival, together with a trend towards higher disease-free survival. In addition, the use of TO has highlighted important differences between patients according to their vulnerability [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] and also between hospitals [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] and has been reported to reduce costs [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. As regards surgical approach, better results were achieved with laparoscopy than with open surgery. Although this finding may be due to a bias (namely, that less complex patients are selected for laparoscopy), other research has found higher rates of TO using a minimally invasive approach [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Therefore, this indicator should be assessed along with survival, clinical results, quality of life and costs to the health system in the definitions of TO for specific pathologies [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eTO was significantly associated with T3 and T4 tumor stages. It is likely that this relationship is influenced by characteristics such as comorbidity, which was not included in the study design but may act as a confounding factor in its analysis. Thus, we believe that future studies of TO should include other factors such as comorbidities, frailty, risk of malnutrition, and other physiological variables such as preoperative hemoglobin.\u003c/p\u003e \u003cp\u003eIn a study using the US National Cancer Database, Aquina et al. [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] analysed a total of 852,988 patients undergoing high-risk cancer surgeries such as gastric, pancreas, colon, rectum, lung, esophagus and ovary resections. Those authors concluded that TO can be used to compare care quality at different cancer centers. On the other hand, expert opinions such as the article by Auer and Balaa [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] question its use in interhospital comparisons given the possible tendency to select patients likely to achieve better clinical results and thus limit the inclusion of high-risk patients. In his initial description, Kolfschoten [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] applied TO in low-risk patients, but as the use of the concept has spread to other settings, patients of all degrees of severity have been included. In our study, for example, no patients were excluded during the risk stratification process.\u003c/p\u003e \u003cp\u003eThe main limitation of this study is its retrospective nature. The information available in the digitized medical records, differences in follow-up or intraoperative technical differences may have significantly increased the risk of bias. The main interest of the study is the novelty of the indicator used. Other strengths are the large sample size, the inclusion of both low- and high-risk patients, and the fact that few studies to date have analysed colon cancer resections from this perspective.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eThis study shows that textbook outcome is a valuable multidimensional quality management tool for assessing oncological results in colon cancer resection. From the patient's point of view, TO is easy to interpret, since it represents the ideal surgical course. An international consensus now needs to be established that can help to standardize the definition of TO in this specific area, and thus allow objective interhospital comparisons to be made.\u003c/p\u003e \u003cp\u003eThe association of TO and survival gives it a significant predictive value. Overall, it is a valuable benchmark for evaluating the quality of gastrointestinal cancer surgery and may be particularly useful in clinical research and in programs designed to improve quality of care in cancer treatment.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cu\u003eSTATEMENTS AND DECLARATIONS:\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors declare no competing interests.\u003c/p\u003e\n\u003cp\u003eAuthors declare no funding.\u003c/p\u003e\n\u003cp\u003eConflict of Interest: The authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003eThe study was authorized by the Ethics Committee (CEIM) of the public Hospital General Universitario de Alicante (HGUA: n\u0026ordm; 2022-103, ISABIAL 2022-0297). The requirement of informed consent was waived due to the retrospective design and the absence of any risk. 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Comparison of Laparoscopic Versus Open Gastrectomy for Treatment of Gastric Cancer: Analysis of a Textbook Outcome. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://home.liebertpub.com/lap\u003c/span\u003e\u003cspan address=\"https://home.liebertpub.com/lap\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. 2019 Apr 10;29(4):458\u0026ndash;64. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.liebertpub.com/doi/\u003c/span\u003e\u003cspan address=\"https://www.liebertpub.com/doi/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1089/lap.2018.0489\u003c/span\u003e\u003cspan address=\"10.1089/lap.2018.0489\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFong Y. Textbook Outcome Nomograms as Multivariate Clinical Tools for Building Cancer Treatment Pathways and Prognosticating Outcomes. JAMA Surg. 2019 Jun;154(6):e190572\u0026ndash;e190572. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://jamanetwork.com/journals/jamasurgery/fullarticle/2731304\u003c/span\u003e\u003cspan address=\"https://jamanetwork.com/journals/jamasurgery/fullarticle/2731304\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1-3 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"langenbecks-archives-of-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"laos","sideBox":"Learn more about [Langenbeck's Archives of Surgery](http://link.springer.com/journal/423)","snPcode":"423","submissionUrl":"https://submission.nature.com/new-submission/423/3","title":"Langenbeck's Archives of Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Textbook outcome, colon cancer, colon carcinoma","lastPublishedDoi":"10.21203/rs.3.rs-2481273/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2481273/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBACKGROUND:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTextbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an \"ideal\" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMATERIAL AND METHODS\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eRetrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRESULTS\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eFive hundred and sixty-four patients were included in the study. TO was achieved in 49.8%. The sample had a mean age of 69 ± 11 years, and 60% were male. Female sex (OR 1.61; 95% CI 2.30-1.13), T3 and T4 classification (OR 2.50, 95% CI 4.59-1.36, and OR 2.55, 95% CI 5.21-1.24 respectively) and laparoscopic approach (OR 1.53, 95% CI 2.33-1.00) were independent factors that were significantly associated with achieving a TO. Patients who achieved TO had higher overall survival (p=0.008) than those who did not. However, with regard to disease-free survival, no statistically significant differences were found (p=0.303).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONCLUSION\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eTO is a useful, easy-to-interpret management tool for measuring oncological results and for predicting patient survival.\u003c/p\u003e\n\u003cp\u003eThe study was registered in the public accessible database \u003cu\u003eclinicaltrials.gov\u003c/u\u003e with the ClinicalTrials.gov ID: NCT05675904. Public release date: 01/05/2023.\u003c/p\u003e","manuscriptTitle":"Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-01-20 22:13:40","doi":"10.21203/rs.3.rs-2481273/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2023-04-09T13:04:28+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2023-03-24T18:01:32+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"28d82027-ba55-428a-abff-c42ca53281b5","date":"2023-03-13T10:06:10+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2023-02-18T17:56:51+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"bae054fd-ebfc-43e0-9e58-f1e95a3a28a5","date":"2023-02-05T09:50:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"b8d0ad66-9e26-4a02-b87f-31019ec1d0b6","date":"2023-02-02T06:17:50+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"dafbb3ba-7d5b-46a6-8c89-808b469bd2b2","date":"2023-02-01T23:57:16+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2023-02-01T16:02:22+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-01-18T13:05:32+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2023-01-18T06:35:39+00:00","index":"","fulltext":""},{"type":"submitted","content":"Langenbeck's Archives of Surgery","date":"2023-01-15T17:33:10+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"langenbecks-archives-of-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"laos","sideBox":"Learn more about [Langenbeck's Archives of Surgery](http://link.springer.com/journal/423)","snPcode":"423","submissionUrl":"https://submission.nature.com/new-submission/423/3","title":"Langenbeck's Archives of Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"1b7e9502-5d00-4b87-af99-4659ef77b9f1","owner":[],"postedDate":"January 20th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2023-10-16T21:19:38+00:00","versionOfRecord":{"articleIdentity":"rs-2481273","link":"https://doi.org/10.1007/s00423-023-02949-7","journal":{"identity":"langenbecks-archives-of-surgery","isVorOnly":false,"title":"Langenbeck's Archives of Surgery"},"publishedOn":"2023-05-30 21:03:20","publishedOnDateReadable":"May 30th, 2023"},"versionCreatedAt":"2023-01-20 22:13:40","video":"","vorDoi":"10.1007/s00423-023-02949-7","vorDoiUrl":"https://doi.org/10.1007/s00423-023-02949-7","workflowStages":[]},"version":"v1","identity":"rs-2481273","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-2481273","identity":"rs-2481273","version":["v1"]},"buildId":"rHA-KDH7Qsr4HCuvH75dn","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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