Biofeedback combined with percutaneous electrical pudendal nerve stimulation for the treatment of low anterior rectal resection syndrome: a study protocol for a randomized controlled trial.

BACKGROUND: Low anterior resection syndrome (LARS) is a distressing condition that affects approximately 25-80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT). METHODS AND ANALYSIS: In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months). DISCUSSION: We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery. TRIAL REGISTRATION: Chinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.

Incidence and risk factors for perineal hernia after robotic abdominoperineal resection: a single-center, retrospective cohort study.

BACKGROUND: Perineal hernia (PH) is a late complication of abdominoperineal resection (APR) that may compromise a patient's quality of life. The frequency and risk factors for PH after robotic APR adopting recent rectal cancer treatment strategies remain unclear. METHODS: Patients who underwent robotic APR for rectal cancer between December 2011 and June 2022 were retrospectively examined. From July 2020, pelvic reinforcement procedures, such as robotic closure of the pelvic peritoneum and levator ani muscles, were performed as prophylactic procedures for PH whenever feasible. PH was diagnosed in patients with or without symptoms using computed tomography 1 year after surgery. We examined the frequency of PH, compared characteristics between patients with PH (PH+) and without PH (PH-), and identified risk factors for PH. RESULTS: We evaluated 142 patients, including 53 PH+ (37.3%) and 89 PH- (62.6%). PH+ had a significantly higher rate of preoperative chemoradiotherapy (26.4% versus 10.1%, p = 0.017) and a significantly lower rate of undergoing pelvic reinforcement procedures (1.9% versus 14.0%, p = 0.017). PH+ had a lower rate of lateral lymph node dissection (47.2% versus 61.8%, p = 0.115) and a shorter operative time (340 min versus 394 min, p = 0.110). According to multivariate analysis, the independent risk factors for PH were preoperative chemoradiotherapy, not undergoing lateral lymph node dissection, and not undergoing a pelvic reinforcement procedure. CONCLUSIONS: PH after robotic APR for rectal cancer is not a rare complication under the recent treatment strategies for rectal cancer, and performing prophylactic procedures for PH should be considered.

Laparoscopy is non-inferior to open surgery for rectal cancer: A systematic review and meta-analysis.

BACKGROUND: Laparoscopic surgery has been endorsed by clinical guidelines for colon cancer, but not for rectal cancer on account of unapproved oncologic equivalence with open surgery. AIMS: We started this largest-to-date meta-analysis to comprehensively evaluate the safety and efficacy of laparoscopy in the treatment of rectal cancer compared with open surgery. MATERIALS & METHODS: Both randomized and nonrandomized controlled trials comparing laparoscopic proctectomy and open surgery between January 1990 and March 2020 were searched in PubMed, Cochrane Library and Embase Databases (PROSPERO registration number CRD42020211718). The data of intraoperative, pathological, postoperative and survival outcomes were compared between two groups. RESULTS: Twenty RCTs and 93 NRCTs including 216,615 patients fulfilled the inclusion criteria, with 48,888 patients received laparoscopic surgery and 167,727 patients underwent open surgery. Compared with open surgery, laparoscopic surgery group showed faster recovery, less complications and decreased mortality within 30 days. The positive rate of circumferential margin (RR = 0.79, 95% CI: 0.72 to 0.85, p < 0.0001) and distal margin (RR = 0.75, 95% CI: 0.66 to 0.85 p < 0.0001) was significantly reduced in the laparoscopic surgery group, but the completeness of total mesorectal excision showed no significant difference. The 3-year and 5-year local recurrence, disease-free survival and overall survival were all improved in the laparoscopic surgery group, while the distal recurrence did not differ significantly between the two approaches. CONCLUSION: Laparoscopy is non-inferior to open surgery for rectal cancer with respect to oncological outcomes and long-term survival. Moreover, laparoscopic surgery provides short-term advantages, including faster recovery and less complications.

Peri-operative, oncological and functional outcomes of robotic versus transanal total mesorectal excision in patients with rectal cancer: A systematic review and meta-analysis.

BACKGROUND: Comparative outcomes of robotic low anterior resection (rTME) and trans-anal total mesorectal excision (TaTME) in patients with low rectal cancer were evaluated. METHODS: A systematic online search was conducted using the following databases: PubMed, Scopus, Cochrane database, The Virtual Health Library, Clinical trials.gov and Science Direct. Comparative studies of rTME versus TaTME for low rectal cancer were included. Primary outcomes were postoperative complications, including anastomotic leak, surgical site infection, and Clavien-Dindo complication rate. Total operative time, conversion to open surgery, intra-operative blood loss, intensive therapy unit (ITU) and total hospital length of stay (LOS), oncological outcomes and functional outcomes were the other evaluated outcome parameters. RESULTS: A total of 12 studies with a total number of 3025 patients divided between rTME (n = 1881) and TaTME (n = 1144) groups were included. There was no significant difference between the two groups for total operative time (P = 0.39), conversion to open surgery (P = 0.29) and intra-operative blood loss (P = 0.62). Clavien-Dindo ≥ 3 complication rate (P = 0.47), anastomotic leak (P = 0.89), rates of re-operation (P = 0.62) and re-admission (P = 0.92), R0 resections (P = 0.52), ITU LOS (P = 0.63) and total hospital LOS (P = 0.30) also showed similar results between the two groups. However, the rTME group had higher rates of total harvested lymph nodes (P = 0.04) and complete total mesorectal excision (TME) resections (P = 0.05). Albeit with a limited dataset, the Wexner and low anterior resection syndrome (LARS) scores showed better functional results in the rTME group compared with the TaTME group (P = 0.0009 and P = 0.00001, respectively). CONCLUSION: Compared with TaTME, rTME seems to provide better functional outcomes, higher lymph node yield and more complete TME resections with a similar post-operative complications profile.

Outcomes Post Beyond Total Mesorectal Excision Plane Resections Following Setting up Complex Colorectal Cancer Service in a District General Hospital.

Background: This study aims to validate the feasibility of a hub-and-spoke model for pelvic exenteration (PE) surgery while upholding favorable patient outcomes. Methods: A retrospective analysis of patients undergoing PE at our trust October 2017 and December 2023 was conducted. Descriptive statistics and Kaplan-Meier survival analysis were employed. Results: Sixty-seven patients underwent PE during the study period, mainly for locally advanced colorectal cancer (n=61, 91.04%). Minimally invasive surgery was performed in 16 cases (Robotic 3, 4.47% / Laparoscopic 13, 19.40) while the rest of patients 51 had open surgery (75.11%). Median hospital stay was 12 days (range:8-20). While 24 patients (35.82%) developed major complications (CD III-IV) post-surgery, there were no mortalities associated with pelvic exenteration in this study. Of the 67 patients undergoing surgery with curative intent, negative margins (R0 resection) were achieved in 57 patients (85.12%). This is comparable to outcomes reported by the PelvEx collaborative (85.07% versus 79.8%). At a median follow-up of 22 months, 15 patient (22.38%) recurred with 10.44% local recurrence rate. The 2 years overall and disease-free survival were 85.31% and 77.0.36%, respectively. Conclusion: Our study suggests that a nascent PE service, supported by specialist expertise and resources, can achieve good surgical outcomes within a district general hospital.

How well do we measure the impact of bowel dysfunction on health-related quality of life after rectal cancer surgery?

BACKGROUND: Rectal cancer surgery risks causing bowel dysfunction, which has an important impact on health-related quality of life. The validity of generic tools used to measure health-related quality of life after bowel dysfunction is unclear. This study aimed to determine the content validity of health-related quality-of-life measurement tools in rectal cancer. METHODS: This was a qualitative single-center study in which adult patients who underwent rectal cancer surgery with sphincter preservation from July 2017 to October 2020 were recruited. Patients were excluded if they developed local metastasis, required a permanent stoma, or had surgery <1 year since recruitment. Telephone-based semi-structured interviews were conducted. Bowel dysfunction was measured using the Low Anterior Resection Syndrome score. Content analysis was achieved using the International Classification of Functioning framework. RESULTS: Recurrent bowel dysfunction-related concepts included "Mental functions," "Defecation functions," "Emotional functions," "Recreation and leisure," "Intimate relationships," and "Remunerative employment." A mean of 7.5 recurrent bowel dysfunction-related concepts were identified within the health-related quality of life instruments analyzed. The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-C30 (n = 11) and the 36-Item Short Form Health Survey (n = 9) covered the greatest number of recurrent bowel dysfunction-related concepts. Concepts such as "Mental functions," "Urination functions," "Sexual functions," "Driving," and "Mobility" were not covered by any instrument. CONCLUSION: The content of traditional health-related quality-of-life instruments is missing important areas that represent the impact of bowel dysfunction after rectal cancer surgery on health-related quality of life. These findings could help improve patient-centered care in rectal cancer surgery.

Association of Surgical Approaches and Outcomes in Total Mesorectal Excision and Margin Status for Rectal Cancer.

INTRODUCTION: Despite being a key metric with a significant correlation with the outcomes of patients with rectal cancer, the optimal surgical approach for total mesorectal excision (TME) has not yet been identified. The aim of this study was to assess the association of the surgical approach on the quality of TME and surgical margins and to characterize the surgical and long-term oncologic outcomes in patients undergoing robotic, laparoscopic, and open TME for rectal cancer. METHODS: Patients with primary, nonmetastatic rectal adenocarcinoma who underwent either lower anterior resection or abdominoperineal resection via robotic (Rob), laparoscopic (Lap), or open approaches were selected from the US Rectal Cancer Consortium database (2007-2017). Quasi-Poisson regression analysis with backward selection was used to investigate the relationship between the surgical approach and outcomes of interest. RESULTS: Among the 664 patients included in the study, the distribution of surgical approaches was as follows: 351 (52.9%) underwent TME via the open approach, 159 (23.9%) via the robotic approach, and 154 (23.2%) via the laparoscopic approach. There were no significant differences in baseline demographics among the three cohorts. The laparoscopic cohort had fewer patients with low rectal cancer (<6 cm from the anal verge) than the robotic and open cohorts (Lap 28.6% versus Rob 59.1% versus Open 45.6%, P = 0.015). Patients who underwent Rob and Lap TME had lower intraoperative blood loss compared with the Open approach (Rob 200 mL [Q1, Q3: 100.0, 300.0] versus Lap 150 mL [Q1, Q3: 75.0, 250.0] versus Open 300 mL [Q1, Q3: 150.0, 600.0], P < 0.001). There was no difference in the operative time (Rob 243 min [Q1, Q3: 203.8, 300.2] versus Lap 241 min [Q1, Q3: 186, 336] versus Open 226 min [Q1, Q3: 178, 315.8], P = 0.309) between the three approaches. Postoperative length of stay was shorter with robotic and laparoscopic approach compared to open approach (Rob 5.0 d [Q1, Q3: 4, 8.2] versus Lap 5 d [Q1, Q3: 4, 8] versus Open 7.0 d [Q1, Q3: 5, 9], P < 0.001). There was no statistically significant difference in the quality of TME between the robotic, laparoscopic, and open approaches (79.2%, 64.9%, and 64.7%, respectively; P = 0.46). The margin positivity rate, a composite of circumferential margin and distal margin, was higher with the robotic and open approaches than with the laparoscopic approach (Rob 8.2% versus Open 6.6% versus Lap 1.9%, P = 0.17), Rob versus Lap (odds ratio 0.21; 95% confidence interval 0.05, 0.83) and Rob versus Open (odds ratio 0.5; 95% confidence interval 0.22, 1.12). There was no difference in long-term survival, including overall survival and recurrence-free survival, between patients who underwent robotic, laparoscopic, or open TME (Figure 1). CONCLUSIONS: In patients undergoing surgery with curative intent for rectal cancer, we did not observe a difference in the quality of TME between the robotic, laparoscopic, or open approaches. Robotic and open TME compared to laparoscopic TME were associated with higher margin positivity rates in our study. This was likely due to the higher percentage of low rectal cancers in the robotic and open cohorts. We also reported no significant differences in overall survival and recurrence-free survival between the aforementioned surgical techniques.

IRIS U kit usefulness in transanal total mesorectal excision for lower rectal cancer to avoid urethral injury.

Transanal total mesorectal excision (taTME) has improved the laparoscopic dissection for rectal cancer in the narrow pelvis. Although taTME has more clinical benefits than laparoscopic surgery, such as a better view of the distal rectum and direct determination of distal resection margin, an intraoperative urethral injury could occur in excision ta-TME. This study aimed to determine the feasibility and efficacy of the ta-TME with IRIS U kit surgery. This retrospective study enrolled 10 rectal cancer patients who underwent a taTME with an IRIS U kit. The study endpoints were the safety of access (intra- or postoperative morbidity). The detectability of the IRIS U kit catheter was investigated by using a laparoscope-ICG fluorescence camera system. Their mean age was 71.4±6.4 (58-78) years; 80 were men, and 2 were women. The mean operative time was 534.6 ± 94.5 min. The coloanal anastomosis was performed in 80%, and 20% underwent abdominal peritoneal resection. Two patients encountered postoperative complications graded as Clavien-Dindo grade 2. The transanal approach with IRIS U kit assistance is feasible, safe for patients with lower rectal cancer, and may prevent intraoperative urethral injury.

Personalized Decisional Algorithms for Soft Tissue Defect Reconstruction after Abdominoperineal Resection for Low-Lying Rectal Cancers.

BACKGROUND: Abdominoperineal resection (APR)-the standard surgical procedure for low-lying rectal cancer (LRC)-leads to significant perineal defects, posing considerable reconstruction challenges that, in selected cases, necessitate the use of plastic surgery techniques (flaps). PURPOSE: To develop valuable decision algorithms for choosing the appropriate surgical plan for the reconstruction of perineal defects. METHODS: Our study included 245 LRC cases treated using APR. Guided by the few available publications in the field, we have designed several personalized decisional algorithms for managing perineal defects considering the following factors: preoperative radiotherapy, intraoperative position, surgical technique, perineal defect volume, and quality of tissues and perforators. The algorithms have been improved continuously during the entire period of our study based on the immediate and remote outcomes. RESULTS: In 239 patients following APR, the direct closing procedure was performed versus 6 cases in which we used various types of flaps for perineal reconstruction. Perineal incisional hernia occurred in 12 patients (5.02%) with direct perineal wound closure versus in none of those reconstructed using flaps. CONCLUSION: The reduced rate of postoperative complications suggests the efficiency of the proposed decisional algorithms; however, more extended studies are required to categorize them as evidence-based management guide tools.

Long-term Quality of Life After Surgery for Mid- and High Rectal Cancer: Hartmann's Procedure Versus Anterior Resection and Abdominoperineal Resection.

BACKGROUND/AIM: Anterior resection is the gold standard surgery for high and middle rectal tumors. In cases where anterior resection is not feasible, the surgeon resorts to a non-restorative approach such as Hartmann's procedure or abdominoperineal resection. It is not well studied how Hartmann's procedure impacts quality of life. This cross-sectional cohort study compares the long-term quality of life after Hartmann's procedure with anterior resection and abdominoperineal resection. PATIENTS AND METHODS: Patients operated for high- or middle rectal cancer in the southern healthcare region of Sweden between 2007 and 2017 were identified and data were extracted from the Swedish Colorectal Cancer Registry. Further clinical variables were retrieved from medical charts. Quality of life was evaluated by SF-12-, EQ-5D-5L- and EORTC QLQ - CR29 questionnaires. RESULTS: Out of 521 patients included, 51 had undergone Hartmann's procedure, 381 anterior resection and 89 abdominoperineal resection. Hartmann patients were significantly older with more comorbidities. Median follow-up time was 104 months. There were no differences between groups in overall quality of life. Patients subjected to Hartmann's procedure reported inferior mobility, self-care, daily activities and reduced estimation of general health compared to those who had anterior resection. Abdominoperineal resection was associated with more impotence compared to Hartmann's procedure. CONCLUSION: Overall long-term QoL after Hartmann's procedure was comparable to anterior resection and abdominoperineal resection. In certain symptoms patients with Hartmann's procedure for rectal cancer scored worse compared to anterior resection, but patients were older and frailer making causal inference impossible.

Robotic Versus Laparoscopic Abdominoperineal Resection for Locally Advanced Rectal Cancer Following Preoperative Chemoradiotherapy.

BACKGROUND/AIM: The usefulness of robotic surgery compared to laparoscopic surgery for rectal cancer has been reported; however, few reports exist on robotic abdominoperineal resection (APR). The aim of this study was to compare the outcomes of robotic and laparoscopic surgery to determine their usefulness in patients with locally advanced rectal cancer who had undergone preoperative chemoradiotherapy (CRT). PATIENTS AND METHODS: This retrospective study included 43 patients with locally advanced rectal cancer who underwent preoperative CRT and robotic (22 patients) or laparoscopic APR (21 patients) between December 2012 and September 2022. We examined the short- and long-term outcomes in the robotic and laparoscopic groups. RESULTS: The median follow-up durations were 36 and 48 months for the robotic and laparoscopic groups, respectively. No significant differences in operative time, intraoperative blood loss, or overall complication rates were observed. However, the incidence of organ/space surgical site infection (SSI) was significantly lower in the robotic surgery group than in the laparoscopic group (9.1% vs. 38.1%, p=0.034) and the 3-year overall survival rate was significantly higher in the robotic surgery group than in the laparoscopic group (95% vs. 67%, p=0.029). CONCLUSION: Robotic APR was associated with a significantly lower rate of organ/space SSIs than the laparoscopic approach, indicating the usefulness of the robotic approach.

Turnbull-Cutait pull-through coloanal anastomosis versus standard coloanal anastomosis plus diverting ileostomy for low anterior resection: a meta-analysis and systematic review.

PURPOSE: Coloanal anastomosis with loop diverting ileostomy (CAA) is an option for low anterior resection of the rectum, and Turnbull-Cutait coloanal anastomosis (TCA) regained popularity in the effort to offer patients a reconstructive option. In this context, we aimed to compare both techniques. METHODS: PubMed, Cochrane, and Scopus were searched for studies published until January 2024. Odds ratios (RRs) with 95% confidence intervals (CIs) were pooled with a random-effects model. Statistical significance was defined as p < 0.05. Heterogeneity was assessed using the Cochran Q test and I2 statistics, with p-values inferior to 0.10 and I2 >25% considered significant. Statistical analysis was conducted in RStudio version 4.1.2 (R Foundation for Statistical Computing). Registered number CRD42024509963. RESULTS: One randomized controlled trial and nine observational studies were included, comprising 1,743 patients, of whom 899 (51.5%) were submitted to TCA and 844 (48.5%) to CAA. Most patients had rectal cancer (52.2%), followed by megacolon secondary to Chagas disease (32.5%). TCA was associated with increased colon ischemia (OR 3.54; 95% CI 1.13 to 11.14; p < 0.031; I2 = 0%). There were no differences in postoperative complications classified as Clavien-Dindo ≥ IIIb, anastomotic leak, pelvic abscess, intestinal obstruction, bleeding, permanent stoma, or anastomotic stricture. In subgroup analysis of patients with cancer, TCA was associated with a reduction in anastomotic leak (OR 0.55; 95% CI 0.31 to 0.97 p = 0.04; I2 = 34%). CONCLUSION: TCA was associated with a decrease in anastomotic leak rate in subgroups analysis of patients with cancer.

Updated evidence of the effectiveness and safety of transanal drainage tube for the prevention of anastomotic leakage after rectal low anterior resection: a systematic review and meta-analysis.

BACKGROUNDS: Anastomotic leakage (AL) represents a major complication after rectal low anterior resection (LAR). Transanal drainage tube (TDT) placement offers a potential strategy for AL prevention; however, its efficacy and safety remain contentious. METHODS: A systematic review and meta-analysis were used to evaluate the influence of TDT subsequent to LAR as part of the revision of the surgical site infection prevention guidelines of the Japanese Society of Surgical Infectious Diseases (PROSPERO registration; CRD42023476655). We searched each database, and included randomized controlled trials (RCTs) and observational studies (OBSs) comparing TDT and non-TDT outcomes. The main outcome was AL. Data were independently extracted by three authors and random-effects models were implemented. RESULTS: A total of three RCTs and 18 OBSs were included. RCTs reported no significant difference in AL rate between the TDT and non-TDT groups [relative risk (RR): 0.69, 95% confidence interval (CI) 0.42-1.15]. OBSs reported that TDT reduced AL risk [odds ratio (OR): 0.45, 95% CI 0.31-0.64]. In the subgroup excluding diverting stoma (DS), TDT significantly lowered the AL rate in RCTs (RR: 0.57, 95% CI 0.33-0.99) and OBSs (OR: 0.41, 95% CI 0.27-0.62). Reoperation rates were significantly lower in the TDT without DS groups in both RCTs (RR: 0.26, 95% CI 0.07-0.94) and OBSs (OR: 0.40, 95% CI 0.24-0.66). TDT groups exhibited a higher anastomotic bleeding rate only in RCTs (RR: 4.28, 95% CI 2.14-8.54), while shorter hospital stays were observed in RCTs [standard mean difference (SMD): -0.44, 95% CI -0.65 to -0.23] and OBSs (SMD: -0.54, 95% CI -0.97 to -0.11) compared with the non-TDT group. CONCLUSIONS: A universal TDT placement cannot be recommended for all rectal LAR patients. Some patients may benefit from TDT, such as patients without DS creation. Further investigation is necessary to identify the specific beneficiaries.

Analysis of risk factors for the sigmoid stoma complications in patients after abdominoperineal resection surgery: An observational study.

To analyze the risk factors for intraperitoneal sigmoid stoma complications after abdominoperineal resection (APR) surgery to guide clinical practice. Patients who were diagnosed with rectal cancer and underwent APR surgery from June 2013 to June 2021 were retrospectively enrolled. The characteristics of the stoma complication group and the no stoma complication group were compared, and univariate and multivariate logistic analyses were employed to identify risk factors for sigmoid stoma-related complications. A total of 379 patients who were diagnosed with rectal cancer and underwent APR surgery were enrolled in this study. The average age of the patients was 61.7 ±â€…12.1 years, and 226 (59.6%) patients were males. Patients in the short-term stoma complication group were younger (55.7 vs 62.0, P < .05) and had a more advanced tumor stage (P < .05). However, there was no significant difference between the long-term stoma complication group and the no stoma complication group. Multivariate logistic regression analysis revealed that operation time was an independent risk factor (P < .05, OR = 1.005, 95% CI = 1.000-1.010) for short-term stoma complications. Both the short-term and long-term stoma complication rates in our institution were low. A longer operation time was an independent risk factor for short-term stoma complications after APR surgery.

[Chinese expert consensus for resection margin in rectal cancer surgery (2024 edition)].

Colorectal cancer is the second most common malignant tumor in China, with rectal cancer accounting for approximately 50% of all cases. While neoadjuvant therapy is essential for diagnosis and treatment, proctectomy with radical resection remains indispensable. Especially for middle and low rectal cancer, the length of the distal resection margin is critical for prognosis, organ preservation, and postoperative quality of life. However, determining a "safe" margin to ensure the radical resection (R0) while maximizing the function of the anal sphincter poses a significant challenge for surgeons. Aiming at this, we conducted a comprehensive review of authoritative guidelines and literature domestically and internationally. We divided the issues related to resection margin in proctectomy into three chapters: (1) the concept and definition of the resection margin; (2) the evaluation of the resection margin in preoperative, intra-operative, and post-operative stages; and (3) radical resection of rectal cancer after neoadjuvant therapy. With the help of the Delphi method, the expert group voted twice for 14 recommendations and finally established the "Chinese Expert Consensus for Resection Margin in Rectal Cancer Surgery (2024 version)". This consensus serves as a valuable reference for clinicians to carry out proctectomy of rectal cancer, which can improve patient's quality of life without affecting their prognosis.

[Influence of neoadjuvant chemoradiotherapy on peritoneal wound healing after abdominoperineal resection].

Objective: To study the influence of neoadjuvant chemoradiotherapy on peritoneal wound recovery after abdominoperineal resection (APR). Methods: This was a retrospective cohort study of data of 219 patients who had been pathologically diagnosed with low rectal cancer and undergone APR in the Union Hospital of Tongji Medical College of Huazhong University of Science and Technology between January 2018 and December 2021. Of these patients, 158 had undergone surgery without any pre-surgical treatment (surgery group), 35 had undergone surgery after neoadjuvant chemotherapy (neoadjuvant chemotherapy group), and 26 had undergone surgery after neoadjuvant chemoradiotherapy (neoadjuvant chemoradiotherapy group). The primary outcome was perineal wound complications occurring within 30 days. The status of wound healing was classified into the following three levels: Level A: abnormal wound seepage that improved after wound discharge; Level B: wound infection and dehiscence; and Level C: Level B plus fever. The patients' general condition, tumor status, perianal wound healing level, and intra- and post-operative recovery were recorded. Results: None of the study patients had any complications during surgery. The duration of surgery was 240.0 (180.0-300.0) minutes, 240.0 (225.0-270.0) minutes and 270.0 (240.0-356.2) minutes in the surgery, neoadjuvant chemotherapy, and neoadjuvant chemoradiotherapy groups, respectively (H=6.508, P=0.039). The rates of perineal wound complications were 34.6% (9/26) and (22.9%, 8/35)in the neoadjuvant chemoradiotherapy group and the neoadjuvant chemotherapy group, being significantly higher than that in the surgery group (10.1%, 16/158). After adjusting for patient age and sex using a logistic regression model, the risk of complications was still higher in the neoadjuvant chemoradiotherapy than in the surgery group (OR=4.6, 95%CI: 1.7-12.7; OR=2.6, 95%CI: 1.0-6.8), these differences being statistically significant (both P<0.05). The duration of hospital stay was 9.5 (7.0-12.0) days, 10.0 (8.0-17.0) days and 11.5 (9.0-19.5) days for patients in the surgery, neoadjuvant chemotherapy, and neoadjuvant chemoradiotherapy groups, respectively (H=0.569, P=0.752). However, after adjusting for patient age and sex by using a generalized linear model, hospital stay was longer in the neoadjuvant chemoradiotherapy than in the surgery group (ß [95% CI]: 4.4 [0.5-8.4], P=0.028). After surgery, 155 of 219 patients required further adjuvant chemotherapy. A higher proportion of patients with than without wound complications did not attend for follow-up (32.2% [10/31] vs. 16.1% [20/124]); this difference is statistically significant (χ2=4.133, P=0.023). Conclusions: In patients with low rectal cancer, neoadjuvant radiotherapy may be associated with an increased risk of perineal wound infection and non-healing.

Low Hartmann's procedure versus abdominoperineal resection for rectal cancer, a propensity score matching cohort study.

BACKGROUND: This study aimed to compare low Hartmann's procedure (LHP) with abdominoperineal resection (APR) for rectal cancer (RC) regarding postoperative complications. METHOD: RC patients receiving radical LHP or APR from 2015 to 2019 in our center were retrospectively enrolled. Patients' demographic and surgical information was collected and analyzed. Propensity score matching (PSM) was used to balance the baseline information. The primary outcome was the incidence of major complications. All the statistical analysis was performed by SPSS 22.0 and R. RESULTS: 342 individuals were primarily included and 134 remained after PSM with a 1:2 ratio (50 in LHP and 84 in APR). Patients in the LHP group were associated with higher tumor height (P < 0.001). No significant difference was observed between the two groups for the incidence of major complications (6.0% vs. 1.2%, P = 0.290), and severe pelvic abscess (2% vs. 0%, P = 0.373). However, the occurrence rate of minor complications was significantly higher in the LHP group (52% vs. 21.4%, P < 0.001), and the difference mainly lay in abdominal wound infection (10% vs. 0%, P = 0.006) and bowel obstruction (16% vs. 4.8%, P = 0.028). LHP was not the independent risk factor of pelvic abscess in the multivariate analysis. CONCLUSION: Our data demonstrated a comparable incidence of major complications between LHP and APR. LHP was still a reliable alternative in selected RC patients when primary anastomosis was not recommended.

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.