Comparative Study of Complications and Incision Esthetic Satisfaction Between Single-Port Laparoscopy and Traditional Laparoscopy in Benign Gynecological Surgery

Objective: single-port laparoscopic surgery (sPls) is an effective, minimally invasive, feasible, and promising surgical technique for the treatment of various benign and malignant gynecological diseases. This study aimed to evaluate the differences in surgical conditions, complications, and esthetic incisions between sPls and traditional laparoscopic surgery (Tls) in benign gynecological surgeries.

Fifty-one eligible patients were included, and their general information (age, surgical approach), surgical conditions (surgical time, blood loss, postoperative first flatus), postoperative pain, and incision healing were collected.

There was a significant difference in the results of hysterectomy between the two groups. The surgical time in the sPls group was significantly shorter than that in the Tls group ( p = 0.026). Furthermore, the sPls group had less blood loss ( p < 0.05) and earlier postoperative first flatus (p < 0.05) than the control group. There was no significant difference in postoperative conditions between the two groups. During the follow-up, it was found that the Vancouver s car s cale score was 8.37 ± 2.30 in the control group and 6.81 ± 2.14 in the study group. The cosmetic effect and satisfaction were better in the sPls group ( p = 0.018). subgroup analysis showed that in other benign gynecological diseases without uterine lesions, sPls significantly improved surgical time, intraoperative blood loss, and postoperative first flatus ( p < 0.05).

sPls demonstrated good clinical efficacy in benign gynecological surgery, with shorter surgical time, less blood loss, earlier postoperative first flatus, fewer complications, and better cosmetic effects of scars.

Gynecological diseases refer to reproductive system diseases in women, including endocrine disorders, infections, and various benign and malignant tumors. 1 Common benign gynecological diseases such as endometriosis, hysteromyoma, and adenomyosis can cause uterine bleeding, pelvic pain, reduced fertility, psychological disorders, and comorbidi - ties,2–4 severely affecting women’s quality of life and mental health. The burden of benign gynecological diseases is high, especially in low- and middle-income countries, where 7.75% of women of reproductive age are affected by benign gyne - cological diseases. 5 Surgery is the main treatment method for most gynecological diseases, 6 especially minimally inva - sive surgery, which plays an important role in the treatment of benign or malignant gynecological diseases. 7,8 Minimally invasive surgery has advantages such as smaller incisions, faster recovery, shorter hospital stays, better cosmetic effects, and higher quality of life than traditional open surgery, 9,10 and it is increasingly favored by medical professionals, patients, and their families. Laparoscopic surgery is a commonly used minimally invasive surgery in gynecology in recent years, which can be used to remove uterine and ovarian lesions, and even clean lymph nodes of malignant tumors. 11,12 Compared with tradi - tional surgery, it has the advantages of less damage, faster recovery, and less postoperative discomfort. It has gradually replaced laparotomy and is widely used in gynecology. 13,14 In recent years, with the increasing demand for minimally invasive surgery and the advancement of surgical instru - ments and techniques, single-port laparoscopic surgery (SPLS) has been introduced into gynecological surgery. As a surgical technique, SPLS usually consists of a single incision through the umbilicus, which is different from traditional laparoscopic surgery (TLS), which requires at least two to three incisions. 15 In the treatment of benign gynecological diseases such as ovarian cysts, hysteromyoma, and ectopic pregnancy, SPLS and TLS have become the gold standard for © 2024 t he a uthor(s). Published with license by taylor & f rancis group, ll C CONTACT Ping Xu [email protected] gynecological o ncology, Zhejiang Jinhua tumor Hospital, 1296 north r ing r oad, Jinhua, Zhejiang, 321000, China. supplemental data for this article can be accessed online at https://doi.org/10.1080/08941939.2024.2419139. https://doi.org/10.1080/08941939.2024.2419139 t his is an o pen a ccess article distributed under the terms of the Creative Commons a ttribution-nonCommercial license ( http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. t he terms on which this article has been published allow the posting of the a ccepted Manuscript in a repository by the author(s) or with their consent. ARTICLE HISTORY r eceived 16 July 2024 a ccepted 15 o ctober 2024

single-port laparoscopic surgery; traditional laparoscopic surgery; gynecology; complications; esthetic incision 2 J. chen e T al. disease treatment. 16,17 There could still be some variations of experimental findings between the two in some illnesses, though. A study on benign ovarian cysts showed that com - pared to TLS, SPLS had no significant difference in hospi - talization costs, but SPLS was associated with shorter operative times, less postoperative pain, and a significantly lower cyst rupture rate (3.0% vs. 22.2%). 18 However, an opposing result was observed in another study. 19 Similar issues have been found in other benign gynecological dis - eases.15,17,20,21 In addition, due to the independence of the study, fewer studies have compared the results of SPLS and TLS in the comprehensive treatment of various benign gyne - cological diseases in clinical practice. Therefore, to determine the effectiveness of SPLS in benign gynecological diseases, this study aimed to compare the advantages and disadvantages of SPLS and TLS in terms of surgical time, postoperative pain, postoperative follow-up, and patient satisfaction in benign gynecological diseases, to assess the feasibility and safety of SPLS in benign gynecolog - ical diseases and provide a new clinical basis for the appli - cation of SPLS in gynecological diseases.

Ethical statement The study was conducted under the principles of the Declaration of Helsinki and obtained ethical approval from the Institutional Review Board and Ethics Committee of our hospital. All participants in this study were fully informed and signed informed consent forms. Sample size calculation This study is designed as a single-center randomized con - trolled trial, with the primary outcome being the amount of bleeding.18,22 The significance level is set at α = 0.05, and the statistical power is 1 – β = 0.80. Utilizing an online sample size calculation tool ( https://www.trialstats.com/statbox/ index.htm/samplesize/estimation?sid=4), we determined that a total sample size of 34 to 124 participants is required. Taking into account a 20% dropout rate and the specific cir - cumstances of our hospital, we have established the target sample size at 80 patients, with 40 participants in each group. Study design and population A total of 80 patients who underwent uterine lesion resec - tion surgery for uterine lesions and those who underwent laparoscopic surgery for adnexal lesions (such as ovarian cysts, ovarian tumors, and ectopic pregnancy) at our hospital from July/2022 to November/2023 were collected. All patients who agreed to participate were randomly assigned to either the SPLS group ( n = 40) or the TLS group ( n = 40) using a computer-generated random number table after signing informed consent forms. Both groups underwent surgery by the same experienced surgical team, ensuring minimal tech - nical variation between the different approaches. Ultimately, due to factors such as prolonged surgical time or significant bleeding caused by severe adhesions, loss to follow-up for patients from other regions, and noncompliance issues, 21 patients in the SPLS group and 30 patients in the TLS con - trol group completed the study. We collected general information on eligible patients, including age, body mass index, and underlying diseases. The inclusion criteria for patients were as follows: (1) gen - eral good condition; (2) no obvious pelvic adhesions; (3) ovarian cysts <8 cm, normal carbohydrate antigen 125 (CA-125) levels; (4) uterus <90 days of pregnancy, good activity; (5) hysteromyoma smaller than 5 cm and solitary; (6) body mass index <35 kg/m2; (7) signed informed consent form; (8) good compliance and able to follow up regularly. The following patients were excluded: (1) umbilical hole dysplasia or infection; (2) history of complex gynecological surgery considered severe pelvic adhesions; (3) submucosal hysteromyoma; (4) cervical myoma; (5) gynecological malig - nant tumors. The detailed selection process of subjects for this study is shown in Figure 1 . Treatment (1) Group SPLS group: General intravenous anesthesia with tracheal intubation was administered. Married patients were posi - tioned in a modified lithotomy position with a minimally invasive uterine manipulator placed via the vagina, while unmarried patients were positioned in a “V” shape without the use of a uterine manipulator, and a urinary catheter was inserted preoperatively. To establish the surgical access, a 20 mm vertical incision was made at the umbilicus, followed by the insertion of a pneumoperitoneum needle and insufflation of CO 2 to a pressure of 10–12 mmHg. A 10 mm trocar was placed at the upper edge of the umbilicus for the laparoscope. Below the umbilical trocar, one or two 5 mm trocars were inserted on both sides for surgical instruments, arranged in a pattern resembling the Chinese character “pin” ( 品). TLS group: The anesthesia method and position were the same as the SPLS group. A 10 mm vertical incision was made at the umbilicus, and after successfully establishing pneumoperi- toneum, a 10 mm laparoscope was inserted. At McBurney’s points on both sides and 1–2 cm above the pubic symphysis, trocars and graspers were inserted through 5 mm incisions. For myomectomy cases, the left McBurney’s incision was extended to 15–20 mm to allow the insertion of a uterine morcellator. The surgical steps were essentially the same as those in SPLS. (2) Surgical procedure Both groups underwent four types of surgeries: hysterec - tomy, adnexectomy, ovarian cystectomy, and myomectomy. The techniques for these procedures were based on estab - lished methods from previous literature. For ovarian cystec - tomy, we followed the approach described by Zuo et  al., 23 which involved flipping and securing the affected ovary to the abdominal wall. After electrocauterization to incise the cyst, it was carefully dissected from the ovarian cortex and JOurnal OF inVesTiga TiVe surger Y 3 completely excised, followed by hemostasis. Similarly, adnex - ectomy was performed in accordance with previous stud - ies,24,25 while myomectomy followed the method outlined by Niu et  al. 26 Hysterectomy was conducted according to the technique described by Xu et  al. 27 (3) Postoperative management Both groups of patients received postoperative care accord - ing to standard protocols, including routine wound dressing changes for the abdominal incision and other nursing measures. Data collection Main observation indicators ( Online Appendix 1 , supple - mentary material): 1. Surgical time (minutes, min): The time was counted from the start of the skin incision to the completion of skin closure. 2. Intraoperative blood loss (milliliters, ml): The total volume of liquid in the negative pressure suction bot - tle was subtracted from the total volume of irrigation fluid, and the blood loss was estimated using the area method. For example, the absorption of a 15 cm × 20 cm gauze was 10 ml, and the absorption of four layers of a 15 cm × 30 cm gauze pad was 60 ml. Total blood loss = Suction volume + Gauze absorption – Various irrigation water volume during surgery. 3. Postoperative first flatus of anus (hours, h): The clin - ical efficacy of patients in the two groups was com - pared. Criteria for efficacy assessment: ① Apparent effectiveness: Patients had no obvious infection after surgery and had satisfactory recovery; ② Effectiveness: Patients had mild infection after surgery but had good recovery; ③ Ineffectiveness: Patients had obvi - ous infection after surgery and had unsatisfactory recovery. Overall efficiency = (apparent effective - ness + effectiveness)/total number × 100%. Secondary observation indicators: 1. Pain scoring at 24 and 48 h after surgery. Changhai Pain Scale ( Figure 2): a combination of the Numerical Rating Scale (NRS) and Visual Analog Scale (V AS). 2. Pain survey questionnaire scoring at 1 month after surgery, also known as Brief Pain Inventory (BP) (Online Appendix 2 ). Figure 1. f low chart of selecting study cohort. Figure 2. Changhai pain scale. 4 J. chen e T al. 3. Esthetic satisfaction score: The Vancouver Scar Scale (Online Appendix 3 ) was used to evaluate scar appearance at 3 months postoperatively. Statistical analysis All statistical analyses were performed using SPSS 26.0 software. Normally distributed continuous variables were presented as mean ± standard deviation and compared using independent samples t-test. Non-normally distrib - uted data were presented as median [interquartile range] and compared using the Mann-Whitney U test. Categorical variables were presented as counts (percentages) and com - pared using the chi-square test or Fisher’s exact test. A two-sided P value < 0.05 was considered statistically significant.

General information This study included 51 patients with respectable benign gynecological tumors and divided them into two groups. There were 30 cases in TLS group, with an average age of 51.77 ± 9.03 years, and 21 cases in SPLS group, with an aver - age age of 49.19 ± 12.56 years. There was no significant dif - ference in age between the two groups ( p > 0.05) (Table 1 ). There were four surgical methods, including hysterectomy, adnexectomy, oophorocystectomy, and myomectomy. TLS was most used for hysterectomy ( p = 0.011), as shown in Table 1. Comparison of basic surgical conditions The perioperative surgical outcomes are shown in Table 2 . Compared with TLS group, SPLS group had shorter surgical time (98.95 ± 48.49 min, p = 0.026), less blood loss (16.76 ± 13.24 mL, p = 0.010), and earlier postoperative first flatus (31.29 ± 5.99 h, p < 0.001). These results indicated a sig - nificant advantage in SPLS. Comparison of pain after surgery The results in Table 3 showed that there were no signifi - cant differences in pain scores between the two groups, whether it was in the short-term postoperative period (24, 48 h) or in the long-term postoperative period (1 month) (p > 0.05). Comparison of incision healing The scar scores were 8.37 ± 2.30 in TLS group and 6.81 ± 2.14 in SPLS group. The wound healing of SPLS was significantly better than TLS ( p = 0.018). SPLS group patients had better cosmetic effects and higher satisfaction with the outcomes than TLS group. Subgroup analysis Comparison of indicators between the two groups in patients undergoing hysterectomy with adnexectomy showed no sig - nificant differences in any parameter ( p > 0.05, Online Appendix 4 ). In other benign gynecological surgeries, the use of SPLS significantly improved surgical time, intraoper - ative blood loss, and postoperative first flatus time ( p < 0.05, Table 4).

In recent years, with the growing focus of gynecological sur - geons on minimally invasive techniques, laparoscopic Table 1. g eneral information of patients in the two groups. Parameters tls group (n = 30) sPls group (n = 21) t value P value age 51.77 ± 9.03 49.19 ± 12.56 0.853 0.398 surgical methods Hysterectomy 20(66.7) 6(28.6) 7.714 0.011 a dnexectomy 24(80.0) 15(71.4) – 0.518 o ophorocystectomy 11(36.7) 6(28.6) 0.364 0.763 Myomectomy 8(26.7) 1(4.8) – 0.064 note: Bold is the P value < 0.05, indicating a significant difference. Table 2. Comparison of surgery conditions between the two groups. group Case surgical time (min) Blood loss (ml) Postoperative first flatus time (h) tls group 30 126.47 ± 37.10 32.17 ± 27.03 38.73 ± 5.83 sPls group 21 98.95 ± 48.49 16.76 ± 13.24 31.29 ± 5.99 t value – 2.296 2.412 4.441 P value – 0.026 0.010 <0.001 note: Bold is the P value < 0.05, indicating a significant difference. Table 3. Comparison of postoperative pain between the two groups. group Case Pain score at 24 h after surgery Pain score at 48 h after surgery Pain score at 1 month after surgery tls group 30 4.07 ± 1.14 2.30 ± 0.54 0.67 ± 0.61 sPls group 21 3.67 ± 0.91 2.33 ± 0.58 0.76 ± 0.70 t value – 1.333 −0.212 −0.518 P value – 0.189 0.833 0.607 Table 4. Comparison o f tls and sPls in other benign gynecological diseases. Indicators tls group (n = 11) sPls group (n = 14) t value P value age 49.82 ± 10.22 46.50 ± 14.26 0.651 0.522 surgical time (min) 106.82 ± 26.28 77.21 ± 32.71 2.443 0.023 Blood loss (ml) 34.55 ± 26.16 11.21 ± 6.32 −3.325 0.001 Postoperative first flatus time (h) 40.55 ± 5.80 29.14 ± 4.59 5.493 <0.001 Pain score at 24 h after surgery 4.09 ± 1.38 3.36 ± 0.93 1.591 0.125 Pain score at 48 h after surgery 2.27 ± 0.65 2.29 ± 0.47 −0.058 0.954 Pain score at 1 month after surgery 0.00[0.00,1.00] 1.00[0.00,1.00] −0.791 0.437 scar scores 8.00 ± 2.05 6.93 ± 2.50 1.150 0.262 note: Bold is the P value < 0.05, indicating a significant difference. JOurnal OF inVesTiga TiVe surger Y 5 surgery has become widely used in the treatment of benign gynecological diseases. 28 Among these, SPLS has gradually emerged as an alternative to TLS due to its association with less tissue damage, superior cosmetic outcomes, reduced postoperative pain, and shorter recovery periods. 20,29 Of these advantages, the most notable is the cosmetic outcome, as SPLS utilizes an umbilical incision, rendering the scar vir - tually invisible, which is particularly appealing to younger female patients. 30 This esthetic benefit has significantly con - tributed to the growing demand for SPLS. The results of this study indicate that compared to TLS, SPLS offers several advantages during the treatment of benign gynecological diseases, including shorter surgical time, reduced blood loss, earlier postoperative first flatus, and better cosmetic outcomes after scar healing. These find - ings are consistent with those of Jiang et  al., 15 who reported that in the SPLS group, specimen extraction time, postoper - ative ambulation time, postoperative first flatus time, and hospital stay were all significantly shorter, and the satisfac - tion with abdominal wall scarring was higher. However, the surgical duration for SPLS was notably longer than for TLS. This extended duration may be attributed to factors such as the smaller sample size, the complexity of the procedures, and the experience of the surgeons. Specifically, the limited operating space within a single port can complicate and pro - long the surgical steps. 31 Additionally, the size of the uterus affects the duration of hysterectomy, with larger uterine weights associated with longer operative times and greater estimated blood loss. 32 Moreover, reports suggest that fewer trocar cannulas in laparoscopic approaches are associated with smaller intraoperative spaces, potentially increasing the time required for the procedure. 33 Therefore, the experience and technical skill of the surgeon are crucial for the success - ful implementation of SPLS. Research on surgical scars and patient satisfaction also supports the cosmetic benefits of SPLS. A meta-analysis of patients undergoing myomectomy showed that the SPLS group had significantly higher follow-up satisfaction scores regarding abdominal scarring compared to the TLS group, 17 indicating that SPLS, by reducing the number of incisions, achieved a more estheti - cally pleasing postoperative appearance, meeting patients’ demand for a “scarless” surgery. Postoperative pain is a critical factor affecting patient recovery, as it influences both the time to ambulation and imposes a significant psychological burden on patients. In our study, there were no significant differences in either early or late postoperative pain scores between the SPLS and TLS groups. This finding suggests that, despite the relatively larger umbilical incision in SPLS, it does not contribute to increased postoperative pain. This observation contrasts with the widely held belief that SPLS generally reduces postoper - ative pain. Theoretically, SPLS should reduce pain due to fewer incisions and less tissue damage. However, some stud - ies have reported contrary findings, indicating that SPLS may not significantly alleviate postoperative pain and could even increase pain due to specific factors. 34,35 We hypothe - size that differences in postoperative pain may be attributed to variations in tissue handling during surgery, particularly inflammatory responses in surrounding tissues and potential postoperative complications such as hernias. Meta-analyses have shown that the incidence of postoperative incisional hernias in SPLS is significantly higher than in TLS, approx - imately three times more frequent. 36,37 This increased inci - dence may contribute to higher postoperative pain in some patients. Therefore, despite the evident cosmetic advantages of SPLS, surgeons should inform patients about potential complications, particularly the risk of incisional hernia, before the procedure. Additionally, the number of trocars used during surgery may also affect postoperative pain. 38 Therefore, reducing the number of trocars or improving sur - gical techniques may help further minimize postopera - tive pain. In this study, we also conducted a subgroup analysis to investigate the differences in outcomes between SPLS and TLS for hysterectomy with adnexectomy and other benign gynecological procedures. The results indicated that, except for hysterectomy with adnexectomy, SPLS offered advantages such as reduced operative time, lower postoperative bleed - ing, and earlier postoperative first flatus in other benign gynecological conditions, suggesting that SPLS has certain benefits in these cases. These advantages may be diminished by the complexity of hysterectomy and adnexectomy and the relatively small sample size. The anatomical complexity of the uterus and adnexa could increase surgical difficulty, thereby reducing the potential advantages of SPLS compared to TLS. Moreover, the limited operating space within a sin - gle incision may contribute to increased surgical time and complexity. For larger ovarian cysts and uterine fibroids, the restricted maneuverability of instruments in SPLS may lead to greater difficulty due to interference between instruments. Additionally, patient factors such as obesity and tall stature can complicate the procedure. Practical experience suggests that combining SPLS with suspension techniques and effec - tive dissection can somewhat expand the surgical field and reduce operational difficulty. 39 Furthermore, robotic-assisted surgery presents a viable solution, utilizing the precision of robotic technology to mitigate the ergonomic limitations of SPLS.40–42 Future research should consider increasing sample sizes and exploring additional optimization strategies to val - idate the advantages and potential applications of SPLS in various clinical scenarios. While this study has provided valuable insights into the comparison between SPLS and TLS for benign gynecological procedures, it is not without limitations that may affect the generalizability and robustness of the results. Firstly, the study’s sample size is limited, particularly in the subgroup analysis of hysterectomy with adnexectomy, where the num - ber of patients is insufficient to achieve adequate statistical power. This small sample size may lead to result instability and limits a comprehensive assessment of the potential dif - ferences between the surgical methods. Secondly, SPLS is technically challenging, especially when dealing with larger lesions. Variations in surgeon experience and skill levels could significantly impact surgical outcomes. Although most surgeries in this study were performed by the same surgical team, the learning curve of the surgeons might still affect the operation time and complication rates. Thirdly, the follow-up period of this study was relatively short, focusing 6 J. chen e T al. primarily on the short-term postoperative recovery phase and not adequately assessing long-term outcomes such as delayed complications (e.g., incisional hernias) or quality of life improvements. Thus, differences in long-term prognosis between SPLS and TLS need further validation through extended follow-up data. Lastly, some postoperative metrics, such as pain scores and scar satisfaction, are based on sub - jective patient assessments, which may be influenced by individual differences, psychological state, and pain toler - ance, potentially introducing bias in the scoring results. This could somewhat obscure the actual differences in postoper - ative recovery between SPLS and TLS. Future research should address these limitations by increasing the sample size, conducting multi-center studies, and extending follow-up periods to more thoroughly evaluate the advan - tages and disadvantages of SPLS versus TLS. Additionally, controlling for surgeon experience and using objective assessment criteria can provide a more comprehensive eval - uation of the clinical effects of these surgical approaches. Author contribution Jian Chen: Conceptualization, Data curation, Writing – Original draft preparation. Mengying Li: Data curation, Visualization, Investigation, Writing – Original draft preparation. Yujiao Lai: Validation, Investigation, Writing – Reviewing and Editing. Ping Xu: Supervision, Software, Writing – Reviewing and Editing. Disclosure statement No potential competing interest was reported by the authors. Ethics approval and consent to participate This study was approved by Zhejiang Jinhua Tumor Hospital Ethics Committee (2022-006-01). Informed consent was waived by the com - mittee because of the retrospective nature of the study. Data availability statement The datasets generated and analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.

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