Short-term outcomes of chemoradiotherapy and local excision versus total mesorectal excision in T2-T3ab,N0,M0 rectal cancer: a multicentre randomised, controlled, phase III trial (the TAU-TEM study).

BACKGROUND: The standard treatment of T2-T3ab,N0,M0 rectal cancers is total mesorectal excision (TME) due to the high recurrence rates recorded with local excision. Initial reports of the combination of pre-operative chemoradiotherapy (CRT) and transanal endoscopic microsurgery (TEM) have shown reductions in local recurrence. The TAU-TEM study aims to demonstrate the non-inferiority of local recurrence and the improvement in morbidity achieved with CRT-TEM compared with TME. Here we describe morbidity rates and pathological outcomes. PATIENTS AND METHODS: This was a prospective, multicentre, randomised controlled non-inferiority trial including patients with rectal adenocarcinoma staged as T2-T3ab,N0,M0. Patients were randomised to the CRT-TEM or the TME group. Patients included, tolerance of CRT and its adverse effects, surgical complications (Clavien-Dindo and Comprehensive Complication Index classifications) and pathological results (complete response in the CRT-TEM group) were recorded in both groups. Patients attended follow-up controls for local and systemic relapse. TRIAL REGISTRATION: NCT01308190. RESULTS: From July 2010 to October 2021, 173 patients from 17 Spanish hospitals were included (CRT-TEM: 86, TME: 87). Eleven were excluded after randomisation (CRT-TEM: 5, TME: 6). Modified intention-to-treat analysis thus included 81 patients in each group. There was no mortality after CRT. In the CRT-TEM group, one patient abandoned CRT, 1/81 (1.2%). The CRT-related morbidity rate was 29.6% (24/81). Post-operative morbidity was 17/82 (20.7%) in the CRT-TEM group and 41/81 (50.6%) in the TME group (P < 0.001, 95% confidence interval 42.9% to 16.7%). One patient died in each group (1.2%). Of the 81 patients in the CRT-TEM group who received the allocated treatment, 67 (82.7%) underwent organ preservation. Pathological complete response in the CRT-TEM group was 44.3% (35/79). In the TME group, pN1 were found in 17/81 (21%). CONCLUSION: CRT-TEM treatment obtains high pathological complete response rates (44.3%) and a high CRT compliance rate (98.8%). Post-operative complications and hospitalisation rates were significantly lower than those in the TME group. We await the results of the follow-up regarding cancer outcomes and quality of life.

Clinical impact of leakage in patients with handsewn vs stapled anastomosis after right hemicolectomy: a retrospective study.

AIM: Anastomotic leakage is a major complication after right hemicolectomy leading to increased morbidity, mortality, length of stay and hospital costs. Previous studies have shown that the type of anastomosis (handsewn or stapled) is a major risk factor for anastomotic leakage. The purpose of this study was to evaluate the clinical impact of anastomotic leakage depending on the type of anastomotic technique (handsewn vs stapled). METHOD: This was an observational, retrospective, cross-sectional study. Data were collected at two major hospitals in Spain from January 2010 to December 2016. Patients had elective right colectomy for cancer with handsewn or stapled ileocolic anastomosis. The main outcome was the grading of postoperative treatments needed to manage anastomotic leakage according to two major classification systems. The other outcomes were demographics, time of hospitalization and death rate. RESULTS: Patients (n = 961) underwent elective surgery for neoplasia of the right colon. Anastomotic leakage was diagnosed in 116 patients (12.07%). Patients with handsewn anastomosis had more Type IIIA surgical complications and received milder treatments than patients with stapled anastomosis (SA) who had more Type IIIB complications and more re-laparotomies (P = 0.004). The clinical impact of anastomotic leakage was significantly more severe (Grade C) in patients with SA than in patients with a handsewn anastomosis (P = 0.007). No differences were found for hospital stay of patients with anastomotic leakage depending on the type of anastomosis (P = 0.275). Death due to anastomotic leakage was similar in both groups. CONCLUSIONS: The clinical impact of anastomotic leakage in patients with handsewn anastomosis is lower than in patients with SA.

Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2-T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME).

PURPOSE: The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME), in many cases requires a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal verge, achieves minimal postoperative morbidity and mortality rates, and does not require an ostomy. The treatment of T2, N0, and M0 cancers remains controversial. Preoperative chemoradiotherapy (CRT) in association with TEM reduces local recurrence and increases survival. The TAU-TEM study aims to demonstrate the non-inferiority of the oncological outcomes and the improvement in morbidity and quality of life achieved with TEM compared with TME. METHODS: Prospective, multicenter, randomized controlled non-inferiority trial includes patients with rectal adenocarcinoma less than 10 cm from the anal verge and up to 4 cm in size, staged as T2 or T3-superficial N0-M0. Patients will be randomized to two areas: CRT plus TEM or radical surgery (TME). Postoperative morbidity and mortality will be recorded and patients will complete the quality of life questionnaires before the start of treatment, after CRT in the CRT/TEM arm, and 6 months after surgery in both arms. The estimated sample size for the study is 173 patients. Patients will attend follow-up controls for local and systemic relapse. CONCLUSIONS: This study aims to demonstrate the preservation of the rectum after preoperative CRT and TEM in rectal cancer stages T2-3s, N0, M0 and to determine the ability of this strategy to avoid the need for radical surgery (TME). TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01308190. Número de registro del Comité de Etica e Investigación Clínica (CEIC) del Hospital universitario Parc Taulí: TAU-TEM-2009-01.

Morbidity after laparoscopic and open rectal cancer surgery: a comparative analysis of morbidity in octogenarians and younger patients.

AIM: Although the oncological adequacy of laparoscopic rectal resection (LR) appears equivalent to open resection (OR), its benefit is controversial in the elderly. The aim of this study was to investigate the influence of LR on morbidity and mortality in octogenarians. METHOD: This was a retrospective analysis of all patients who underwent rectal surgery for cancer between 2003 and 2013 in a teaching hospital. The primary aim of the study was to assess the influence of surgical approach on mortality and morbidity of rectal resection in patients ≥ 80 years old. Regression analysis was performed to control the effect of covariables on the clinical outcome. RESULTS: Of 408 patients 203 were in the LR group and 205 in the OR group including 303 (74.3%) less than 80 years and 105 (25.7%) over 80 years. The mortality was lower in the LR group compared with the OR group for patients under 80 years (0% vs 4.6%; P = 0.049) and no different in the over 80 group (11.5% vs 9.4%; P = 0.859). In younger patients, the OR group showed longer hospital stay (9 vs 7 days; P < 0.001) and more complications (44.1% vs 29.8%; P = 0.042). Medical complications were more frequent in LR group than OR group octogenarians (40.4% vs 20.8%; P = 0.009) as well as grade C anastomotic leakage (13.8 vs 10.7; P = 0.041). CONCLUSION: LR for rectal cancer showed clinical advantages in patients under 80 years and was as safe as OR in patients over 80 years, although the advantages of laparoscopic surgery were lost in the elderly group due to a higher rate of medical complications. OR may be an option in elderly patients with important comorbidities.

Predicting postoperative mortality after colorectal surgery: a novel clinical model.

AIM: The aim of this study was to develop and externally validate a clinically, practical and discriminative prediction model designed to estimate in-hospital mortality of patients undergoing colorectal surgery. METHOD: All consecutive patients who underwent elective or emergency colorectal surgery from 1990 to 2005, at the Zaandam Medical Centre, The Netherlands, were included in this study. Multivariate logistic regression analysis was performed to estimate odds ratios (ORs) and 95% confidence intervals (CIs) linking the explanatory variables to the outcome variable in-hospital mortality, and a simplified Identification of Risk in Colorectal Surgery (IRCS) score was constructed. The model was validated in a population of patients who underwent colorectal surgery from 2005 to 2011 in Barcelona, Spain. Predictive performance was estimated by calculating the area under the receiver operating characteristic curve. RESULTS: The strongest predictors of in-hospital mortality were emergency surgery (OR = 6.7, 95% CI 4.7-9.5), tumour stage (OR = 3.2, 95% CI 2.8-4.6), age (OR = 13.1, 95% CI 6.6-26.0), pulmonary failure (OR = 4.9, 95% CI 3.3-7.1) and cardiac failure (OR = 3.7, 95% CI 2.6-5.3). These parameters were included in the prediction model and simplified scoring system. The IRCS model predicted in-hospital mortality and demonstrated a predictive performance of 0.83 (95% CI 0.79-0.87) in the validation population. In this population the predictive performance of the CR-POSSUM score was 0.76 (95% CI 0.71-0.81). CONCLUSIONS: The results of this study have shown that the IRCS score is a good predictor of in-hospital mortality after colorectal surgery despite the relatively low number of model parameters.

Multivisceral Resection for Locally Advanced Rectal Cancer: Prognostic Factors Influencing Outcome.

AIMS: To assess outcome in patients with locally advanced rectal cancer undergoing multivisceral resection. METHODS: Retrospective study of 30 consecutive patients (mean age 67.8 years) with primary locally advanced rectal cancer undergoing en bloc multivisceral resection of the organs involved with curative intent between 1998 and 2010. Overall survival, local and distal recurrence, and disease-free survival were analyzed by the Kaplan-Meier method. Risk factors for clinical outcome were obtained using a Cox multivariate model. RESULTS: Postoperative complications occurred in 76.7% of patients and the in-hospital mortality rate was 10%. The median follow-up was 28.8 months. A total of 19 patients died at follow-up. Of the 11 patients who were alive, 7 were free of disease. In the multivariate analysis, lymph node involvement, stage II, and lymph vascular invasion were significantly associated with survival, and stage III showed a strong trend towards significance. Suture dehiscence (peritonitis and intra-abdominal abscess) showed a significant trend towards a higher local recurrence. Lymph vascular invasion was associated with a higher distant recurrence. CONCLUSION: Lymph node involvement was associated with worse survival, whereas stage II and absence of lymph vascular invasion were associated with a better survival. Lymph vascular invasion was associated with a higher distant recurrence.

[Laparoscopic treatment for gastroesophageal reflux in children]. / Tratamiento laparoscópico del reflujo gastroesofágico infantil.

Since 1998 we have operated 5 patients with gastroesophageal reflux (GER) by laparoscopic procedure, aged between 6 and 16 years. In the 3 smaller patients we have done the Boix-Ochoa antireflux technique. In the other 2 patients we have done the Nissen fundoplicature. At 3 months of postoperative course, the 24 hours-pHmetry is normal in all the patients. They also refer the absence of symptomatology of vomiting and/or pyrosis. In 3 patients we could do a postoperative manometry of the distal esophagic sphincter, with normal values. The postoperative dysphagia of the first seems to be lesser in the group treated with the Boix-Ochoa technique.

Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial.

PURPOSE: Prevention of parastomal hernia represents an important aim when a permanent stoma is necessary. The objective of this work is to assess whether implantation of a prophylactic prosthetic mesh during laparoscopic abdominoperineal resection contributed to reduce the incidence of parastomal hernia. METHODS: Rectal cancer patients undergoing elective laparoscopic abdominoperineal resection with permanent colostomy were randomized to placement of a large-pore lightweight mesh in the intraperitoneal/onlay position by the laparoscopic approach (study group) or to the control group (no mesh). Parastomal hernia was defined radiologically by a CT scan performed after 12 months of surgery. The usefulness of subcutaneous fat thickness measured by CT to discriminate patients at risk of parastomal hernia was assessed by ROC curve analysis. RESULTS: Thirty-six patients were randomized, 19 to the mesh group and 17 to the control group. Parastomal hernia was detected in 50 % of patients in the mesh group and in 93.8 % of patients in the control group (P = 0.008). The AUC for thickness of the subcutaneous abdominal was 0.819 (P = 0.004) and the optimal threshold 23 mm. Subcutaneous fat thickness ≥23 mm was a significant predictor of parastomal hernia (odds ratio 15.7, P = 0.010), whereas insertion of a mesh was a protective factor (odds ratio 0.06, P = 0.031). CONCLUSIONS: Use of prophylactic large-pore lightweight mesh in the intraperitoneal/onlay position by a purely laparoscopic approach reduced the incidence of parastomal hernia formation. Subcutaneous fat thickness ≥23 mm measured by CT was an independent predictor of parastomal hernia.