An International Multicenter Prospective Study Evaluating the Long-term Oncological Impact of Adjuvant Chemotherapy in ypN+ Rectal Cancer.

OBJECTIVE: To assess the oncological benefit of adjuvant chemotherapy (AC) in node positive (ypN+) rectal cancer after neoadjuvant chemoradiotherapy and radical surgery. BACKGROUND: The evidence for AC after total mesorectal excision for locally advanced rectal cancer is conflicting and the net survival benefit is debated. METHODS: An international multicenter comparative cohort study was performed comparing oncological outcomes in tertiary rectal cancer centers from the Netherlands and France. Patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy followed by total mesorectal excision surgery and with positive lymph nodes on histologic examination (ypN+) were included for analysis. Kaplan-Meier curves were generated to compare disease-free (DFS) and overall survival in AC and non-AC groups. RESULTS: Of 1265 patients screened, a total of 239 rectal cancer patients with ypN+ disease were included. Demographic and clinical characteristics were similar in both groups. Higher systemic recurrence rates were observed in the non-AC group compared with those who received AC [32.0% (n=40) vs 17.5% (n=11), respectively, P =0.034]. DFS at 1 and 5 years postoperatively were significantly better in the AC group (92% vs 80% at 1 year; 72% vs 51% at 5 years, P =0.024), whereas no difference in overall survival was observed. CONCLUSIONS: In this multicenter comparative cohort study, we identified an oncological benefit of AC in both systemic recurrence and DFS in ypN+ rectal cancer patients. From this data, systemic chemotherapy continues to confer oncological benefit in locally advanced ypN+ rectal cancer.

IDEAL Stage 2a/b prospective cohort study of transanal transection and single-stapled anastomosis for rectal cancer.

AIM: There are several anastomotic techniques available to facilitate restorative rectal cancer surgery after total mesorectal excision (TME), including double-stapled anastomosis (DST) and handsewn coloanal anastomosis (CAA). However, to date no one technique is superior with regard to anastomotic leakage (AL) or functional outcomes. Transanal transection single-stapled anastomosis (TTSS) aims to overcome some of the technical challenges and offer comparable clinical and functional outcomes to traditional anastomotic techniques. The aim of this study was to explore the role of TTSS in modern rectal cancer surgery and to provide comparative clinical and functional outcome data with DST and CAA. METHOD: A prospective cohort study was undertaken to assess the safety and clinical and patient-reported outcomes associated with the TTSS procedure. All patients undergoing sphincter-preserving surgery for rectal cancer with an anastomosis performed within 6 cm of the anal verge between January 2016 and April 2021 were prospectively enrolled into this study. Clinical and patient-reported outcome data, including low anterior resection syndrome (LARS) assessment, were collected. The primary endpoint was anastomotic leakage within 30 days. RESULTS: A total of 275 patients participated in this study, with 70 (25%) patients undergoing a TTSS, 110 (40%) undergoing a DST and 95 (35%) undergoing a CAA. Patients undergoing a CAA had more distal tumours than those having a TTSS or DST, with a median tumour height of 5, 7 and 9 cm (p < 0.001), respectively. We observed a statistically significant reduction in AL in the TTSS group compared with the DST group, with rates of 8.6% versus 20.9% (p = 0.028). There was no difference in LARS scores between patients undergoing TTSS and DST (p = 0.228), while patients with a CAA had worse LARS scores than TTSS patients (p = 0.002). CONCLUSION: TTSS is a technically safe and feasible anastomotic technique in rectal cancer surgery as an alternative to DST and CAA. Its advantages over DST are a reduced AL rate and, over CAA, improved function. It should therefore be considered as an alternative technique to improve clinical and patient-reported outcomes in restorative rectal cancer surgery.

Comparison between preoperative chemoradiotherapy and lateral pelvic lymph node dissection in clinical T3 low rectal cancer without enlarged lateral lymph nodes.

AIM: The standard strategy for clinical T3 rectal cancer without enlarged lateral lymph nodes is preoperative chemoradiotherapy (CRT) followed by total mesorectal excision (TME) in Western countries and TME with bilateral lateral pelvic lymph node dissection (LPLND) in Japan. This study compared surgical, pathological and oncological results of these two strategies. METHOD: Patients who underwent preoperative CRT followed by TME in France (CRT + TME group) and those who underwent TME with LPLND in Japan (TME + LPLND group) for clinical T3 rectal adenocarcinoma without enlarged lateral lymph nodes from 2010 to 2016 were retrospectively analysed. RESULTS: In total, 439 patients were included in this study. The estimated local recurrence rate (LRR), disease-free survival and overall survival at 5 years post-surgery was 4.9%, 71% and 82% in the CRT + TME group, and 8.6%, 75% and 90% in the TME + LPLND group, respectively. Lateral LRR versus non-lateral LRR was 0.5% versus 4.2% in the CRT + TME group and 1.8% versus 6.2% in the TME + LPLND group. Obturator nerve injury and isolated pelvic abscess were shown only in the TME + LPLND group. Urinary complications were more frequent in the TME + LPLND group than in the CRT + TME group. CONCLUSION: Disease-free survival was not significantly different after TME with LPLND and after CRT followed by TME. LRR was not significantly different after both strategies; however, there was a trend for higher LRR after TME with LPLND than after CRT followed by TME. Obturator nerve injury, isolated lateral pelvic abscess and urinary complications should be noted when TME with LPLND is applied.

Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial.

INTRODUCTION: Low-pressure pneumoperitoneum (LLP) in laparoscopy colorectal surgery (CS) has resulted in reduced hospital stay and lower analgesic consumption. Microsurgery (MS) in CS is a technique that has a significant impact with respect to postoperative pain. The combination of MS plus LLP, known as low-impact laparoscopy (LIL), has never been applied in CS. Therefore, this trial will assess the efficacy of LLP plus MS versus LLP alone in terms of decreasing postoperative pain 24 h after surgery, without taking opioids. METHOD: PAROS II will be a prospective, multicentre, outcome assessor-blinded, randomised controlled phase III clinical trial that compares LLP plus MS versus LLP alone in patients undergoing laparoscopic surgery for colonic or upper rectal cancer or benign pathology. The primary outcome will be the number of patients with postoperative pain 24 h after the surgery, as defined by a visual analogue scale rating ≤3 and without taking opioids. Overall, PAROS II aims to recruit 148 patients for 50% of patients to reach the primary outcome in the LLP plus MS arm, with 80% power and an 5% alpha risk. CONCLUSION: The PAROS II trial will be the first phase III trial to investigate the impact of LIL, including LLP plus MS, in laparoscopic CS. The results may improve the postoperative recovery experience and decrease opioid consumption after laparoscopic CS.

Stapled side-to-side anastomosis for ileostomy reversal: a simple and reproducible technique with video.

INTRODUCTION: Protective diverting ileostomy is commonly performed in rectal surgery to avoid septic complications of low colorectal anastomosis. Ileostomy closure usually occurs three months after the surgery and can be realized in two ways: hand sewn or stapled. Existing randomized studies comparing the two techniques showed no difference in terms of complications. METHODS: Our study describes the standard technique of ileostomy reversal as done in Bordeaux University Hospital in 10 steps individually illustrated and with an explicative video. We also collected data concerning the 50 last patients who underwent an ileostomy reversal in our center from June 2021 to June 2022. RESULTS: Mean duration of the ileostomy closure was 46.8 minutes, and the mean total hospital stay was 4.66 days. Five of 50 (10%) patients had a post-operative bowel obstruction, 2/50 (4%) patients had a post-operative bleeding, 1/50 (2%) patient had a wound infection, and there was no anastomotic leakage observed. CONCLUSION: Stapled side-to-side anastomosis is a rapid, simple, and reproducible technique for ileostomy reversal. There are no more complications compared to hand-sewn anastomosis. It engenders an additional cost compensated by the gain in operating time which altogether saves money.

Half of Postoperative Deaths After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Could be Preventable: A French Root Cause Analysis on 5562 Patients.

OBJECTIVE: To perform a retrospective root-cause analysis of postoperative death after CRS and HIPEC procedures. BACKGROUND: The combination of CRS and HIPEC is an effective therapeutic strategy to treat peritoneal surface malignancies, however it is associated with significant postoperative mortality. METHODS: All patients treated with a combination of CRS and HIPEC between January 2009 and December 2018 in 22 French centers and died in the hospital, were retrospectively analyzed. Perioperative data of the 101 patients were collected by a local senior surgeon with a sole junior surgeon. Three independent experts investigated the typical root cause of death and provided conclusions on whether postoperative death was preventable (PREV group) or not (NON-PREV group). A typical root cause of preventable postoperative death was classified on a cause-and-effect diagram. RESULTS: Of the 5562 CRS+HIPEC procedures performed, 101 in-hospital deaths (1.8%) were identified, of which a total of 18 patients of 70 years old and above and 20 patients with ASA score of 3. Etiology of peritoneal disease was mainly colorectal. A total of 54 patients (53%) were classified in the PREV group and 47 patients (47%) in the NON-PREV group. The results of the study show that in the PREV group, WHO performance status 1-2 was more frequent and the Median Peritoneal Cancer Index was higher compared with those of the NON-PREV group. The cause of death in the PREV group was classified as: (i) preoperatively for debatable indication (59%), (ii) intraoperatively (30%) and (iii) postoperatively in 17 patients (31%). A multifactorial cause of death was found in 11 patients (20%). CONCLUSION: More than half of the postoperative deaths after combined CRS and HIPEC may be preventable, mainly by following guidelines regarding preoperative selection of the patients and adequate intraoperative decisions.

Transanal versus abdominal low rectal dissection for rectal cancer: long-term results of the Bordeaux' randomized trial.

AIM: The aim of the current study is to report long-term outcomes after transanal low rectal dissection compared with the conventional laparoscopic approach within the context of the Bordeaux' randomized trial. Results from this randomized trial have indicated that transanal approach was more effective than laparoscopic dissection regarding the rate of negative circumferential resection margin (CRM). Despite a high number of publications regarding the transanal approach for TME, there were no long-term data on survival and local recurrence which are now required. METHODS: One hundred patients with low rectal cancer suitable for laparoscopic TME with handsewn coloanal anastomosis were randomized in transanal versus laparoscopic low rectal dissection from 2008 to 2012. The randomization ratio was 1:1. All patients included in the trial were considered for long-term assessment. Local recurrence, overall- and disease-free survival were assessed by Kaplan-Meier and compared with Log-rank test. RESULTS: The follow up was 60.2 months, similar in both group (p = 0.321). Overall, there were no differences of long-term outcomes. There was a significant association between CRM involvement and local recurrence (p = 0.011), however, the 5-year local recurrence rate was 4%, without any significant difference between transanal and laparoscopic dissection: 3% vs. 5%; p = 0.300. The 5-year disease-free survival was 73%: 72% vs. 74; p = 0.351. CONCLUSION: Lower positivity of the circumferential resection margin was reported after transanal low rectal dissection, but it did not translate into a decreased incidence of local recurrence. Further investigations are necessary to demonstrate advantages of this new procedure.

Potential sexual function improvement by using transanal mesorectal approach for laparoscopic low rectal cancer excision.

OBJECTIVE: Preliminary results of the transanal approach for low rectal cancer suggest better oncological outcomes than the conventional laparoscopic approach. We currently report the functional results. METHODS: From 2008 to 2012, 100 patients with low rectal cancer and suitable for sphincter-saving resection were randomized between transanal and laparoscopic low rectal dissection. Patients derived from this randomized trial were enrolled for functional assessment. End points were bowel function (LARS bowel and Wexner continence scores) and urogenital function (IPSS, IIEF-5 and FSFI-6 scores) obtained by questionnaires sent to patients with a follow-up more than 12 months. RESULTS: Overall, 76 patients were eligible and 72 responded to the questionnaire: 38 in the transanal group and 34 in the laparoscopic group. The bowel function did not differ between the transanal and the laparoscopic groups: LARS 36 versus 37 (p = 0.941) and Wexner 9 versus 10 (p = 0.786). The urologic function was also similar between the two groups: IPSS 5.5 versus 3.5 (p = 0.821). Among sexually active patients before surgery, 20 of 28 (71 %) patients in the transanal group and 9 of 23 (39 %) in the laparoscopic group maintained an activity after surgery (p = 0.02). Erectile function was also better in men after transanal compared to laparoscopic low rectal dissection: IIEF 17 versus 7 (p = 0.119). CONCLUSION: Transanal approach for low rectal cancer did not change bowel and urologic functions compared to the conventional laparoscopic approach. However, there was a trend to a better erectile function with a significantly higher rate of sexual activity in the transanal group.

Laparoscopic total mesorectal excision with coloanal anastomosis for rectal cancer.

OBJECTIVE: Oncologic and functional outcomes were compared between transanal and transabdominal specimen extraction after laparoscopic coloanal anastomosis for rectal cancer. BACKGROUND: Laparoscopic coloanal anastomosis is an attractive new surgical option in patients with low rectal cancer because laparotomy is not necessary due to transanal specimen extraction. Risks of tumor spillage and fecal incontinence induced by transanal extraction are not known. METHODS: Between 2000 and 2010, 220 patients with low rectal cancer underwent laparoscopic rectal excision with hand-sewn coloanal anastomosis. The rectal specimen was extracted transanally in 122 patients and transabdominally in 98 patients. End points were circumferential resection margin, mesorectal grade, local recurrence, survival, and functional outcome. RESULTS: The mortality rate was 0.5% and surgical morbidity rate was 17%. The rate of positive circumferential resection margin was 9% and the mesorectum was graded complete in 79%, subcomplete in 12%, and incomplete in 9%. After a follow-up of 51 months (range, 1-151), the local recurrence rate was 4% and overall survival and disease-free survival rates were 83% and 70% at 5 years, respectively. The continence score was 6 (range, 0-20). There was no difference of mortality rate, morbidity rate, circumferential resection margin, mesorectal grade, local recurrence (4% vs 5%, P = 0.98), and disease-free survival rate (72% vs 68%, P = 0.63) between transanal and transabdominal extraction groups. Continence score was also similar (6 vs 6, P = 0.92). CONCLUSIONS: Transanal extraction of the rectal specimen did not compromise oncologic and functional outcome after laparoscopic surgery for low rectal cancer and seems as a safe option to preserve the abdominal wall.

An analysis of feasibility of robotic colectomy: post hoc analysis of a phase III randomised controlled trial.

With global expansion of robotic surgery, there is increasing interest in its application in colonic surgery. This study aimed to report the feasibility of robotic assisted colonic resection as a post hoc analysis of a randomised controlled trial (RCT) by comparing outcomes following laparoscopic and robotic colectomy. The PAROS trial was a phase III RCT that compared outcomes in low pressure (LP, 7 mmHg) and standard pressure (SP, 12 mmHg) pneumoperitoneum in elective colectomy. A post hoc analysis was performed to compare clinical and operative outcomes in laparoscopic and robotic colonic resection in a high volume colorectal surgery practice. A health economic comparison was also performed. Data were analysed using IBM SPSS StatisticsTM, version 20. 127 patients were compared [34% (n = 43) robotic, 66% (n = 84) laparoscopic]. LP pneumoperitoneum was practiced in 47% (n = 20) robotic and 50% (n = 42) laparoscopic cases. Cancer procedures were more commonly performed in the robotic group (p = 0.009). Clinical outcomes were comparable including post-operative surgical complications (p = 0.493). Operative times were longer (p = 0.005) but length of hospital stay (LOS) was one day shorter in the robotic group (p = 0.05). Conversion to SP pneumoperitoneum was required in 9.5% (n = 8) of the LP laparoscopic group compared to 2.3% (n = 1) of the LP robotic group. Surgeons reported good operative visibility in all robotic cases and 94% (n = 80) laparoscopic cases. Considering, capital investment and maintenance, instrumentation and LOS, robotic cases were €651 more expensive per case. Robotic-assisted surgery is feasible in colonic resection and may facilitate shorter LOS and the possibility to complete MIS using low pressure pneumoperitoneum.

Time trend in surgical indications and outcomes in ulcerative colitis-A two decades in-depth retrospective analysis.

BACKGROUND: Recent data regarding the impact of biologics and new surgical techniques on the indications and outcomes of colectomy for ulcerative colitis (UC) are limited. AIMS: The present study aimed at determining the trend of colectomy in UC by comparing colectomy indications and outcomes between 2000 and 2010 and 2011-2020. METHODS: This observational retrospective study was conducted in two tertiary hospitals, including consecutive patients who underwent colectomy between 2000 and 2020. All data concerning UC history, treatment and surgeries were collected. RESULTS: Among the 286 patients included, 87 underwent colectomy in 2001-2010 and 199 in 2011-2020. Patients' characteristics were similar between groups, except for prior biologic exposure (50.6 % vs. 74.9%; p<0.001). The indications of colectomy significantly decreased for refractory UC (50.6 % vs. 37.7%; p = 0.042), but were similar for acute severe UC (36.8 % vs. 42.2%; p = 0.390) and (pre)neoplastic lesions (12.6 % vs. 20.1%; p = 0.130). A widespread use of laparoscopy (47.7 % vs. 81.4%; p<0.001) was associated with fewer early complications (12.6 % vs. 5.5%; p = 0.038). CONCLUSION: Over the last two decades, the proportion of surgery for refractory UC significantly decreased compared to other surgical indications while surgical outcomes improved despite larger exposure to biologics.

Oncological strategy following R1 sphincter-saving resection in low rectal cancer after chemoradiotherapy.

AIM: Sphincter-saving resection (SSR) for low rectal cancer remains challenging due to the high risk of positive resection margin (R1). Long-term outcomes and the dedicated oncological strategy are not well established in this situation. The aim of this study was to define the more appropriate strategy according to the patterns of recurrence. METHODS: Between 1994 and 2014, patients treated by SSR for low rectal cancer with preoperative chemoradiotherapy were included. Three types of recurrences were defined: local (LR), distant (DR) and mixed (MR). Recurrences and survival after R0 and R1 resection were analysed by Kaplan-Meier and compared with the log-rang test. RESULTS: Among 394 patients receiving SSR, 42 (10.6%) had R1 resection. Independent factors of R1 resection were EMVI (OR2.24,95%IC1.10-4.53,p = 0.025) and no tumor downstaging (OR8.41,95%IC2.50-8.32,p = 0.001). Both 5-year disease free and overall survival, and 5-year distant and local recurrence, were significantly worse after R1 resection. The overall recurrence after R1 resection was 57% (24/42), 7% had LR, 36% DR and 14% MR. Time to DR was shorter than time to LR (11.1 vs. 34.3) months. In all cases of MR, DR occurred before LR (12.1 vs. 34.3) months, meaning that after R1 resection, the first concern was DR. CONCLUSION: R1 resection after SSR for low rectal cancer reflects a more aggressive and systemic disease. Prognosis depends on DR in about 90% of cases, suggesting that pelvic control should not be the priority in the oncological strategy after R1. Adjuvant systemic chemotherapy ought to be preferred to salvage abdominoperineal resection.

The feasibility of implementing an enhanced recovery programme in patients undergoing pelvic exenteration.

BACKGROUND: Pelvic exenteration (PE) is a complex operative procedure, reserved for patients with locally advanced and recurrent pelvic malignancies. PE is associated with a high index of post-operative morbidity. Enhanced Recovery After Surgery (ERAS) programmes have been successful in improving postoperative outcomes, however, its application in PE has not been studied. The aim of our study is to assess the feasibility and short-term impact of ERAS on PE. METHODS: A dedicated PE ERAS programme was developed reflecting the complexity of differing subtypes of PE. A prospective cohort study was undertaken to evaluate the feasibility of implementing our PE ERAS between 2016 and 2020. The primary endpoint of this study was overall compliance with the ERAS programme. RESULTS: 145 patients were enrolled into our PE ERAS programme, with 86 (56.2%) patients undergoing a soft tissue PE, 27 (17.6%) a vascular PE and 32 (20.9%) a bony PE. The median overall compliance to the PE ERAS programme was 70% (IQR 55.5-88.8). There were no observed differences between overall compliance to the PE ERAS programme between different subtypes of PE (p = 0.60). Patients with higher compliance with the PE ERAS programme had a shorter LoS (p < 0.001), less post-operative morbidity (p < 0.001), reduced severity of Clavien-Dindo grade of morbidity (p < 0.001) and fewer readmissions (p = 0.03). CONCLUSIONS: The principles of ERAS can be readily applied to patients undergoing PE, with high adherence to the ERAS programme associated with improved clinical outcomes.