Robotic transanal minimally invasive surgery (R-TAMIS): current evidence in the treatment of early rectal neoplasia.

This study is a systematic review of randomised and non-randomised trials and follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines. The following databases were searched as part of the systematic review in October 2023: Medline, EMBASE and Web of Science. The terms included (R-TAMIS OR TAMIS OR Transanal OR Trans-anal) AND (Rect*). The last date of search was 1st of October 2023. The grey literature was also searched to further identify other suitable publications. The studies were assessed for eligibility based on the following inclusion criteria. Randomised controlled trials (RCTs), cohort studies or large case series (≥ 5 patients) investigating the use of R-TAMIS to resect rectal neoplasia (benign or malignant) were eligible for inclusion in our analysis. A database was created using the reference managing software EndNote X9™. Two researchers (NOS and HCT) reviewed outputs from the searches independently of each other. Initially, duplicates were removed. The study titles were then screened and assessed for potential relevance. The abstracts of selected potential studies were then read and assessed for eligibility for inclusion, based on the inclusion/exclusion criteria detailed above. The rejected studies were grouped together in the database by their reason for exclusion. The full texts of the abstracts deemed eligible for inclusion were then further analysed using the same criteria. In order to extract and store data efficiently, the Cochrane Collaboration screening and data extraction tool, Covidence, was used [ 14 ]. Data was collected by two reviewers (NOS and HCT) independently, using the following headings: study details, study design, population, intervention, comparison groups and outcomes. Conflicts between the two reviewers were resolved following an open discussion and a final decision by the senior author (MK). Assessment of potential biases for the non-RCT studies was assessed using the Newcastle–Ottawa scale (NOS) risk of bias tool, and the results were tabulated. This assessment tool grades each study as being ‘satisfactory’ or ‘unsatisfactory’ across various categories. We assigned stars to evaluate study quality: 7 stars, ‘very good’; 5–6 stars, ‘good’; 3–4 stars, ‘satisfactory’; and 0–2 stars, ‘unsatisfactory’. The critical appraisal was completed by two reviewers independently (NOS and HCT), where once again a third reviewer (MK) was asked to arbitrate in cases of discrepancies in opinion. Our systematic review was registered on PROSPERO in October 2023 (470657).

The literature search described above yielded a total of 782 results (Supplementary Material S1 ). Following the removal of 163 duplicates, 619 studies were screened. After the initial screening, 53 abstracts were reviewed and assessed for eligibility, of which 30 were selected for full-text review. From these 30 full texts, a total of 18 studies met the inclusion criteria and were included in our analysis. Seven of the included studies were cohort studies; one prospective, six retrospective [ 1 , 5 , 15 – 19 ]. The remaining 11 studies were case series [ 11 , 20 – 29 ]. Lee et al. provided a comparison of outcomes between L-TAMIS and R-TAMIS in their comparative study [ 5 ]. Table  1 summarises the methodological characteristics of the included studies. Table 1 Methodological characteristics of the included studies Study Country Journal Impact factor Study type Atallah et al. [ 20 ] USA Techniques in Coloproctology 3.5 Case series Baker et al. [ 15 ] Australia Colorectal Disease 3.4 Prospective cohort study Fok et al. [ 21 ] Australia International Journal of Medical Robotics and Computer Assisted Surgery 2.5 Case series Hompes et al. [ 22 ] UK British Journal of Surgery 5.6 Case series Huang et al. [ 16 ] Taiwan Asian Journal of Surgery 3.5 Retrospective cohort study Lee et al. [ 5 ] USA Surgical Endoscopy 3.5 Retrospective cohort study Liu et al. [ 18 ] USA Surgical Endoscopy 3.5 Retrospective cohort study Liu et al. [ 23 ] USA Techniques in Coloproctology 3.5 Case series Liu et al. [ 17 ] USA Updates in Surgery 2.7 Retrospective cohort study Lo et al. [ 24 ] USA Surgical Endoscopy 2.5 Case series Marks et al. [ 1 ] USA Diseases of Colon and Rectum 3.9 Retrospective cohort study Ngu et al. [ 25 ] Taiwan International Journal of Medical Robotics and Computer Assisted Surgery 2.5 Case series Paull et al. [ 26 ] USA Journal of Robotic Surgery 2.3 Case series Ruiz et al. [ 29 ] Spain Cirugia Espanola 1.9 Case series Tomassi et al. [ 19 ] USA Diseases of the Colon and Rectum 3.9 Retrospective cohort study Warren et al. [ 11 ] Australia Techniques in Coloproctology 3.5 Case series Wassef et al. [ 27 ] USA Journal of Gastrointestinal Surgery 3.2 Case series Yao et al. [ 28 ] China Surgical Innovation 1.5 Case series Methodological characteristics of the included studies In regards to quality assessment, seven studies were ‘very good’, nine studies were ‘good’, two studies were ‘satisfactory’ and zero studies were ‘unsatisfactory’ when scored using the Newcastle–Ottawa Scale risk of bias tool. Supplementary Material S2 summarises the results of our risk of bias assessment. The total number of participants from the 18 included studies was 317. The median follow-up across studies was 30 months (range 12–63). Basic participant characteristics are presented in Table  2 . Indications for R-TAMIS included resection of benign neoplasia, early malignant lesions, lesions unresectable by endoscopy and select T2/T3 lesions in patients unfit for or unwilling to proceed with radical surgery. Table 2 Basic participant characteristics Study Patients Male:Female Age (mean +/− SD ) BMI Pre-operative diagnosis Atallah et al. [ 20 ] 9 4:5 65 26 Benign neoplasia of rectum not amenable to endoscopic retrieval, selected T1 lesions, T2/T3 lesions in unfit patients Baker et al. [ 15 ] 11 6:5 70 +/− 12 26 ‘Rectal lesions identified on colonoscopy’ 6 Invasive, 5 other Fok et al. [ 21 ] 5 5:0 67 - Benign rectal polyps or T1 tumours Hompes et al. [ 22 ] 15 8:8 65 +/− 14 28 +/− 5 ‘Rectal lesions’ Huang et al. [ 16 ] 23 11:12 60 +/− 13 24 +/− 3 Early rectal cancer T1 or cCR after CRTx Lee et al. [ 5 ] 40 (L-TAMIS 21, R-TAMIS 19) - L-TAMIS: 65 R-TAMIS: 67 L-TAMIS: 29 R-TAMIS: 30 Benign and malignant rectal lesions Liu et al. [ 18 ] 34 23:11 63 +/− 10 29 +/− 6 Early-stage rectal neoplasm (uTis or uT1N0M0), T1 carcinoid, incomplete endoscopic resection of polyps, partial resection for palliative control of rectal bleeding in metastatic disease Liu et al. [ 23 ] 5 3:2 58 - Endoscopically unresectable polyps or T1 rectal cancers Liu et al. [ 17 ] 28 20:8 62 +/− 10 30 +/− 6 Endoscopically unresectable polyps or low-risk malignancies (no LVI, no TB, well-moderate differentiation, favourable location) Lo et al. [ 24 ] 16 - 63 - Endoscopically unresectable tumours Marks et al. [ 1 ] 26 13:13 62 27 Benign polyp, T1 cancer, selected T2 cancer after neoadjuvant therapy Ngu et al. [ 25 ] 6 2:4 62 +/− 8 27 Patients with cCR after neoadjuvant therapy for rectal cancer Paull et al. [ 26 ] 21 13:8 Si: 56 +/− 13 FCD: 55 +/− 17 Si: 27 +/− 5 FCD: 28 +/− 7 T0-T1 N0 Ruiz et al. [ 29 ] 9 5:4 72 +/− 8 - Benign rectal lesions or T1 with good prognostic criteria Tomassi et al. [ 19 ] 58 - - 28 +/− 5 uT1N0, uT2N0, Stage 3 with cCR, polyps, carcinoids, GIST Warren et al. [ 11 ] 8 - - - - Wassef et al. [ 27 ] 19 11:8 68 +/− 10 31 Incomplete endoscopic resection, not amenable neither to endoscopic resection nor conventional transanal excision Yao et al. [ 28 ] 24 10:14 59 +/− 12 24 12 AC (7cCR, 4cT1, 1cT2), 3 CIS, 2 inconclusive, 3 NE, 3 TVA, 1 endometriosis cCR  clinical complete response, CRTx  chemoradiotherapy, LVI  lymphovascular invasion, GIST  gastrointestinal stromal tumour, AC  adenocarcinoma, CIS  carcinoma in situ, NE  neuroendocrine, TVA tubulovillous adenoma Basic participant characteristics ‘Rectal lesions identified on colonoscopy’ 6 Invasive, 5 other 40 (L-TAMIS 21, R-TAMIS 19) L-TAMIS: 65 R-TAMIS: 67 L-TAMIS: 29 R-TAMIS: 30 Si: 56 +/− 13 FCD: 55 +/− 17 Si: 27 +/− 5 FCD: 28 +/− 7 cCR  clinical complete response, CRTx  chemoradiotherapy, LVI  lymphovascular invasion, GIST  gastrointestinal stromal tumour, AC  adenocarcinoma, CIS  carcinoma in situ, NE  neuroendocrine, TVA tubulovillous adenoma DaVinci robotic platforms (S, Si, SP or Xi) were used in all but two of the included studies reporting platform models [ 1 , 5 , 11 , 15 – 20 , 22 – 25 , 27 – 29 ]. Fok et al. utilised the Medrobotics Flex Robotic System on their cohort, whereas Paull et al. compared outcomes between the DaVinci Si and Medrobotics Flex Robotic System in their respective studies on R-TAMIS [ 21 , 26 ]. Patient positioning throughout studies included lithotomy, modified lithotomy, prone jack-knife and hockey-stick decubitus. Variable positions within individual studies were attributed to surgeon preference or tumour location (anterior, posterior, lateral). Fifteen studies reported using the Applied Medical GelPOINT Path Transanal Access Platform. Hompes et al. use a transanal glove port, generally considered a safe, inexpensive and readily available alternative tool in transanal surgery [ 22 ]. Operative details are demonstrated in Table  3 . The overall mean operative time across the included studies was calculated as 110 +/− 22 min. Table 3 Operative detail s Study Robotic system Position TAMIS port Operative time (mean +/− SD) Estimated blood loss Atallah et al. [ 20 ] DaVinci S/Si Modified lithotomy GelPOINT 124 35 ml Baker et al. [ 15 ] DaVinci Xi Lithotomy GelPOINT 67 +/− 17 - Fok et al. [ 21 ] Medrobotics Flex System Lithotomy - 142 - Hompes et al. [ 22 ] DaVinci Si - Glove port 109 +/− 40 - Huang et al. [ 16 ] DaVinci Si/Xi Prone jack-knife GelPOINT 112 +/− 59 - Lee et al. [ 5 ] DaVinci Si/Xi Prone jack-knife GelPOINT L-TAMIS: 100 R-TAMIS: 102 L-TAMIS: 15 ml R-TAMIS: 5 ml Liu et al. [ 18 ] DaVinci Xi Prone jack-knife or lithotomy GelPOINT 100 - Liu et al. [ 23 ] - Lithotomy GelPOINT - - Liu et al. [ 17 ] DaVinci Xi Lithotomy GelPOINT 133 +/− 47 - Lo et al. [ 24 ] DaVinci Xi Prone jack-knife or lithotomy GelPOINT 87 17.5 ml Marks et al. [ 1 ] DaVinci SP Modified lithotomy GelPOINT 199 +/− 116 10 +/− 46 ml Ngu et al. [ 25 ] DaVinci Xi Modified lithotomy GelPOINT 125 +/− 43 Minimal Paull et al. [ 26 ] DaVinci Si or Medrobotics Flex System Prone jack-knife or high lithotomy GelPOINT Si: 167 +/− 84 FCD: 110 +/− 40 Si: 37.5 +/− 38.3 FCD: 9.5 +/− 13.6 Ruiz et al. [ 29 ] DaVinci Si Lithotomy GelPOINT 76 +/− 23 37.4 +/− 8.6 ml Tomassi et al. [ 19 ] DaVinci Xi/Si Hockey-stick decubitus OR prone jack-knife OR lithotomy GelPOINT 82 +/− 41 - Warren et al. [ 11 ] DaVinci Xi Prone jack-knife GelPOINT - - Wassef et al. [ 27 ] - Prone jack-knife - 97 +/− 17 Minimal Yao et al. [ 28 ] DaVinci Xi/Si Lithotomy or prone jack-knife GelPOINT 140 +/− 45 Minimal Operative detail s L-TAMIS: 100 R-TAMIS: 102 L-TAMIS: 15 ml R-TAMIS: 5 ml Si: 167 +/− 84 FCD: 110 +/− 40 Si: 37.5 +/− 38.3 FCD: 9.5 +/− 13.6 Peri-operative outcomes are illustrated in Table  4 . Complications were divided into major (Clavien Dindo ≥ 3) and minor (Clavien Dindo < 3). Overall complication rate was 9.7% ( n  = 29/300). Minor and major complications were observed in 7% ( n  = 21/300) and 2.7% ( n  = 8/300), respectively. Of the major complications, four were bleeding requiring endoscopic intervention, one pelvic abscess requiring drainage, one poor wound healing requiring re-operative, one peritoneal violation requiring conversion and repair and one post-operative stenosis requiring dilatation. Table 4 Peri-operative details Study Length of stay (days) Minor complications Major complications Readmission Follow-up Atallah et al. [ 20 ] 1.4 +/− 1.1 - - - 14 +/− 9 months Baker et al. [ 15 ] 1.8 +/− 0.9 0 1 (bleeding requiring endoscopic clipping) 0 2 weeks Fok et al. [ 21 ] 0.8 +/− 0.6 0 0 0 30 days Hompes et al. [ 22 ] 1.7 +/− 1.2 1 0 0 - Huang et al. [ 16 ] 4.3 +/− 2.6 0 0 0 9.6 months Lee et al. [ 5 ] L-TAMIS: 10 h R-TAMIS: 10.5 h L-TAMIS: 1 R-TAMIS: 1 0 0 - Liu et al. [ 18 ] 1 1 (C. Diff infection requiring antibiotics) 0 0 188 +/− 209 days Liu et al. [ 23 ] 0 0 0 0 30 days Liu et al. [ 17 ] 82% 0 days 1 (post-operative hypotension) 1 (POD9 bleeding requiring endoscopy) 1 24 +/− 9 months Lo et al. [ 24 ] 2.8 +/− 2.8 2 (stool incontinence, abscess requiring antibiotics) 1 (poor wound healing requiring re-operation) 1 80 days Marks et al. [ 1 ] 73% 0 days 3 (wound dehiscence requiring antibiotics) 1 (pelvic abscess requiring IR drain) 0 4 +/− 4 months Ngu et al. [ 25 ] 4.2 +/− 1.3 0 0 0 21 +/− 9 months Paull et at. [ 26 ] - - 2 (peritoneal violation requiring conversion and repair, rectal stenosis requiring dilatations) 0 - Ruiz et al. [ 29 ] 2.5 +/− 1.2 2 (urinary retention, respiratory infection) 0 0 19 +/− 2 months Tomassi et al. [ 19 ] 90% 0 days 4 (2 urinary retention, nausea, suture line dehiscence requiring antibiotics) 2 (bleeding requiring endoscopy) - - Warren et al. [ 11 ] - - - - - Wassef et al. [ 27 ] 79% 0 days 6 (4 diarrhoea, pain, urgency) 0 - - Yao et al. [ 28 ] 4.6 +/− 2 0 0 0 24 +/− 10 months Peri-operative details L-TAMIS: 10 h R-TAMIS: 10.5 h L-TAMIS: 1 R-TAMIS: 1 Tumour specifications were similar across the included studies. Specimen fragmentation occurred in only four cases. The pooled margin positivity rate across studies was 3.8% ( n  = 11/286). Out of the reported, the overall local recurrence (benign or malignant) occurred in 2.2% ( n  = 5/232) of patients within the specified follow-up period. The recurrence locations included the proctectomy scar site, anorectal junction and surgical bed. The histopathological and oncological data is demonstrated in Table  5 . Table 5 Histopathological and oncological data Study Lesion diameter (cm) Distance to anal verge (cm) Surface area (cm 2 ) Fragmentation Positive margins Recurrence Atallah et al. [ 20 ] 3.1 +/− 1.4 6.8 +/− 2.3 - 0 1/9 0 Baker et al. [ 15 ] 3.8 +/− 1.2 7.3 - 1/11 1/11 - Fok et al. [ 21 ] 3.2 8.3 - 0 1/5 - Hompes et al. [ 22 ] - 7.3 +/− 2 8 +/− 5.9 - 2/15 - Huang et al. [ 16 ] 2.5 5 +/− 1.5 - 0 2/23 0 Lee et al. [ 5 ] - L-TAMIS: 7.8 R-TAMIS: 8.2 L-TAMIS: 17 R-TAMIS: 17 - L-TAMIS: 2/23 R-TAMIS: 1/19 - Liu et al. [ 18 ] 2.6 +/− 1.1 8.6 +/− 3.6 7.7 +/− 9.8 0 0 - Liu et al. [ 23 ] 3 9.7 8.9 0 0 - Liu et al. [ 17 ] 4.1 +/− 3.1 7.8 +/− 3.9 - - 1/28 0 Lo et al. [ 24 ] 4.1 - - 0 0 - Marks et al. [ 1 ] 2.8 +/− 1.3 3.5 +/− 7.5 - 0 0 0 Ngu et al. [ 25 ] 2.8 +/− 1.2 6.5 +/− 1.5 - 0 0 0 Paull et al. [ 26 ] - Si: 11.1 +/− 3.8 FCD: 9.6 +/− 3.6 - - 0 0 Ruiz et al. [ 29 ] - 6.4 +/− 1.5 21.5 +/− 12.1 0 0 0 Tomassi et al. [ 19 ] 3.3 +/− 1.7 8.8 +/− 2.5 - 1/58 3/58 3/58 (adjacent to proctotomy scar, surgical bed, recurrent polyp) Warren et al. [ 11 ] - - - 0 - 0 Wassef et al. [ 27 ] 2.8 +/− 0.9 7.5 +/− 3.5 - 2/19 0 1/19: site of excision Yao et al. [ 28 ] 2.8 +/− 1.1 6.8 +/− 2.1 - 0 0 1/24: anorectal junction Histopathological and oncological data L-TAMIS: 7.8 R-TAMIS: 8.2 L-TAMIS: 17 R-TAMIS: 17 L-TAMIS: 2/23 R-TAMIS: 1/19 Si: 11.1 +/− 3.8 FCD: 9.6 +/− 3.6 Only two of the studies included in our analysis reported costs associated with R-TAMIS [ 5 , 22 ]. Lee et al. reported direct costs of $3562 and $4440.92 of L-TAMIS and R-TAMIS respectively in their comparative study [ 5 ]. Hompes et al. reported a far more economical cost of €837 for a single R-TAMIS case in their institute [ 22 ]. Neither study incorporated the capital costs of robotic platforms in their calculations.

Our review highlights the current evidence for R-TAMIS in the local excision of rectal lesions. While R-TAMIS appears to have complication, margin negativity and recurrence rates superior to those of L-TAMIS published elsewhere in the literature, accurate conclusions cannot be drawn in the absence of comparative studies. Future research focusing on comparing these two approaches will shed light on best practices.

Transanal minimally invasive local excision remains an acceptable treatment option for early-stage rectal tumours (T1, N0) within 3–8 cm of the anal verge in the absence of nodal involvement on local staging [ 30 ]. While this procedure has traditionally been performed laparoscopically, recent evidence has suggested R-TAMIS as a safe alternative, with better articulation and superior visualisation [ 24 ]. We sought to synthesise currently available data on R-TAMIS, to assess its safety and efficacy profile on cases to date. Our review was comprised of 317 patients from 18 cohort studies or large case series (≥ 5 patients) highlighting practical aspects of R-TAMIS in addition to peri-operative and oncological outcomes. Overall complication rate from R-TAMIS was 9.7%. Clear margins (R0) were reported in 96.2% of patients. Local recurrence occurred in 2.2% of patients during the specified follow-up periods. A recent systematic review of laparoscopic TAMIS outcomes in over 1200 cases by Kim et al. found an overall complication rate of 18.4% ( n  = 222/1205) [ 31 ]. Margin positivity rates were also elevated at 8.6% ( n  = 101/1173). Finally, local recurrence was reported as 7.2% ( n  = 54/746). While these findings suggest a potential benefit of R-TAMIS, these studies were observational and non-comparative, making side-by-side comparison difficult and unreliable. To date, only one study has been published directly comparing outcomes between the laparoscopic and robotic-assisted approach in patients undergoing transanal local excision of rectal lesions. In their single-centre review of 40 consecutive patients, Lee et al. compared the two approaches in terms of peri-operative outcomes, histopathological outcomes and cost [ 5 ]. Their review found no significant difference between L-TAMIS and R-TAMIS in any outcome other than cost, which was significantly higher in the R-TAMIS group (median direct cost $3562 vs. $4440.92). A breakdown of cost was not provided in this study. Our study has several limitations. Despite only including cohort studies or large case series, the majority of included studies contained small numbers of participants, which are by default highly susceptible to potential selection bias. Similarly, a lack of comparative studies made meta-analysis of results and a statistical comparison between surgical approaches not feasible. Further studies on larger populations, ideally in the form of randomised control trials or matched cohorts, are required before conclusions can be drawn on the superiority of one modality over another. Nevertheless, R-TAMIS appears to be a safe and feasible alternative to L-TAMIS, in the transanal local excision of rectal tumours.

Robotic transanal minimally invasive surgery (R-TAMIS) was introduced in 2012 for the excision of benign rectal polyps and low grade rectal cancer [ 1 ]. Robotic platforms offer the benefits of wristed articulation, 3D optics and improved ergonomics, combatting issues posed by traditional laparoscopic TAMIS (L-TAMIS) [ 2 , 3 ]. Theoretical benefits of R-TAMIS include superior oncologic resections and increased dexterity, via fine motion scaling and articulated instruments respectively [ 4 ]. Similarly, the use of a robotic platform averts the need of an active surgical assistant in the already confined work space [ 5 ]. Despite promising reports in the literature, there is a void of large comparative studies, particularly comparing peri-operative and oncological outcomes between R-TAMIS and L-TAMIS [ 5 ]. In addition, most of the current literature on R-TAMIS are small series or individual case reports, limiting the power and interpretation of results [ 6 – 13 ]. We aim to collate the existing data surrounding the use of R-TAMIS to treat rectal neoplasms from cohort studies and larger case series, providing a foundation for future, large-scale, comparative studies.

Below is the link to the electronic supplementary material. Supplementary file1 (DOCX 43.8 kb) Supplementary file1 (DOCX 43.8 kb)