Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer:A Multicenter Randomized Controlled Trial

The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer.A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients.Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated.The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001.It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0

Aspects on colostomy construction, complications and stoma function

Aim: The aim of this thesis was to evaluate the importance of surgical technique for stoma complications as well as stoma function in patients operated with colostomy. Methods: Five papers are included: Three observational studies (three papers), one randomized control trial (two papers). Clinical data has been collected from medical records, operative notes, the Swedish Colorectal Cancer Registry, prospectively registered clinical records forms and patient reported data through questionnaires. Results: The incidence of stoma related complications is high and may be affected by surgical technique but not stoma function (paper I). Most patients seem to live a full life with their stoma (paper II). A loop colostomy does not seem to reduce the risk for postoperative complications after surgery for obstructing colorectal cancer but it does affect the stoma related complications (paper III). The incidence of parastomal hernia was not affected by the surgical technique used under colostomy construction (paper IV-V). Conclusion: Surgical technique when colostomies are performed influences the occurrence of short-term complications in patients operated with abdominoperineal excision. Parastomal hernia incidence is not affected by the surgical technique used for colostomy construction. Stoma type does not affect the risk for postoperative complications

Aspects on colostomy construction, complications and stoma function

Aim: The aim of this thesis was to evaluate the importance of surgical technique for stoma complications as well as stoma function in patients operated with colostomy. Methods: Five papers are included: Three observational studies (three papers), one randomized control trial (two papers). Clinical data has been collected from medical records, operative notes, the Swedish Colorectal Cancer Registry, prospectively registered clinical records forms and patient reported data through questionnaires. Results: The incidence of stoma related complications is high and may be affected by surgical technique but not stoma function (paper I). Most patients seem to live a full life with their stoma (paper II). A loop colostomy does not seem to reduce the risk for postoperative complications after surgery for obstructing colorectal cancer but it does affect the stoma related complications (paper III). The incidence of parastomal hernia was not affected by the surgical technique used under colostomy construction (paper IV-V). Conclusion: Surgical technique when colostomies are performed influences the occurrence of short-term complications in patients operated with abdominoperineal excision. Parastomal hernia incidence is not affected by the surgical technique used for colostomy construction. Stoma type does not affect the risk for postoperative complications

Stoma-related symptoms in patients operated for rectal cancer with abdominoperineal excision

The primary aim of this study was to characterize the frequency, severity, and distress of symptoms from the colostomy and colostomy acceptance in rectal cancer patients. The secondary aims were to study the symptomatic parastomal herniation, its relationship to stoma-related symptoms, and potential risk factors for the development of symptomatic parastomal herniation

Rectus abdominis muscle atrophy, prophylactic mesh, and stoma placement : retrospective findings from a prospective multicenter trial

Purpose The primary aim of this study was to investigate whether rectus abdominis muscle atrophy is associated with a lower risk of developing parastomal hernia. Secondary objectives were to assess whether the use of prophylactic mesh is a risk factor for rectus abdominis muscle atrophy and whether the position of the stoma within the rectus abdominis muscle affects the risk of parastomal hernia. Methods This retrospective study analysed patients from a prospective, randomised, multicentre trial in which rectal cancer patients were randomised to stoma creation with or without prophylactic mesh. Computed tomography at 12 months was evaluated to identify parastomal hernia, rectus abdominis muscle atrophy and position of stoma in the rectus abdominis muscle. Results Out of 149 patients, rectus abdominis muscle atrophy was observed in 9% and parastomal hernia in 42% of patients. There was no association between rectus abdominis muscle atrophy and parastomal hernia (p = 0.80; RR 1.07; CI 0.62–1.86), nor between prophylactic mesh and rectus abdominis muscle atrophy (p = 0.19; RR 2.00; CI 0.7–5.73). Stoma placement within the rectus abdominis muscle also showed no association with parastomal hernia development (p = 0.69; RR 0.97; CI 0.81–1.15). Conclusion This study found no statistically significant association between rectus abdominis muscle atrophy and parastomal hernia. The use of prophylactic mesh was not a risk factor for rectus abdominis muscle atrophy, and stoma placement within the rectus abdominis muscle was not associated with parastomal hernia. The previously reported association between prophylactic mesh, rectus abdominis muscle atrophy, and parastomal hernia was not confirmed in this cohort

Stoma-Const - the technical aspects of stoma construction:study protocol for a randomised controlled trial

BACKGROUND: The construction of a colostomy is a common procedure, but the evidence for the different parts of the construction of the colostomy is lacking. Parastomal hernia is a common complication of colostomy formation. The aim of this study is to standardise the colostomy formation and to compare three types of colostomy formation (one including a mesh) regarding the development of parastomal hernia. METHODS/DESIGN: Stoma-Const is a Scandinavian randomised trial comparing three types of colostomy formation. The primary endpoint is parastomal herniation as shown by clinical examination or CT scan within one year. Secondary endpoints are re-admission rate, postoperative complications (classified according to Clavien-Dindo), stoma-related complications (registered in the case record form at stoma care nurse follow-up), total length of hospital stay during 12 months, health-related quality of life and health economic analysis as well as re-operation rate and mortality within 30 days and 12 months of primary surgery. Follow-up is scheduled at 4-6 weeks, and 6 and 12 months. Inclusion is set at 240 patients. DISCUSSION: Parastomal hernia is a common complication after colostomy formation. Several studies have been performed with the aim to reduce the rate of this complication. However, none are fully conclusive and data on quality of life and health economy are lacking. The aim of this study is to develop new standardised techniques for colostomy formation and evaluate this with patient reported outcomes as well as clinical and radiological assessment. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01694238.2012-09-24