Stoma-related complications: a report from the Stoma-Const randomized controlled trial.

AIM: The impact of construction techniques on the development of stoma complications is partly undiscovered. The aim of this paper was to report and analyse the impact of the three surgical techniques in a randomized controlled trial Stoma-Const on stoma-related complications as well as identifying risk factors and patient-reported stoma function as a planned secondary analysis. METHODS: This was a randomized, multicenter trial where all patients scheduled to receive an end colostomy were invited to participate. Patients were randomized to one of three techniques for stoma construction; cruciate fascial incision, circular incision or prophylactic mesh. Stoma complications were assessed by a surgeon and stoma care nurses within 1 year postoperatively. RESULTS: Two hundred and nine patients were randomized. Patient demographics were similar in all three groups. Data on stoma-related complications were available for analysis in 201 patients. A total of 127 patients (63%) developed some type of stoma complication within 1 year after surgery. The risk ratio (95% CI) for stoma complications was 0.93 (0.73; 1.2) between cruciate vs. circular incision groups and 1.02 (0.78; 1.34) between cruciate vs. mesh groups. There were no statistically significant differences between the groups regarding parastomal hernia rate and no risk factors could be identified. CONCLUSION: This randomized trial confirmed a high prevalence of stoma-related complications but could not identify an impact of surgical technique or identify modifiable risk factors for stoma-related complications.

Methods of Colostomy Construction: No Effect on Parastomal Hernia Rate: Results from Stoma-const-A Randomized Controlled Trial.

OBJECTIVE: The primary objective of this trial was to compare the parastomal hernia rates 1 year after the construction of an end colostomy by 3 surgical techniques: cruciate incision, circular incision in the fascia and using prophylactic mesh. Secondary objectives were evaluation of postoperative complications, readmissions/reoperations, and risk factors for parastomal hernia. SUMMARY OF BACKGROUND DATA: Colostomy construction techniques have been explored with the aim to improve function and reduce stoma complications, but parastomal herniation is frequent with an incidence of approximately 50%. METHODS: A randomized, multicenter trial was performed in 3 hospitals in Sweden and Denmark; all patients scheduled to receive an end colostomy were asked to participate. Parastomal hernia within 12 months was determined by computed tomography of the abdomen in prone position and by clinical assessment. Complications, readmissions, reoperations, and risk factors were also assessed. RESULTS: Two hundred nine patients were randomized to 1 of the 3 arms of the study. Patient demographics were similar in all 3 groups. Assessment of parastomal hernia was possible in 185 patients. The risk ratio (95% confidence interval) for parastomal hernia was 1.25 (0.83; 1.88), and 1.22 (0.81; 1.84) between cruciate versus circular and cruciate versus mesh groups, respectively. There were no statistically significant differences between the groups with regard to parastomal hernia rate. Age and body mass index were found to be associated with development of a parastomal hernia. CONCLUSION: We found no significant differences in the rates of parastomal hernia within 12 months of index surgery between the 3 surgical techniques of colostomy construction.

Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).

BACKGROUND: Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial. METHODS: Early closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector. RESULTS: Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations. CONCLUSIONS: The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage. CLINICAL TRIAL: Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.

The type of stoma matters-morbidity in patients with obstructing colorectal cancer.

PURPOSE: A loop colostomy may reduce the risk of severe intraabdominal complications in patients with obstructing colorectal cancer compared to an end colostomy. The aim of this study was to relate complications to the type of stoma, and a secondary aim was to evaluate whether the type of colostomy had an impact on time until oncological/surgical treatment. METHODS: All patients who underwent surgery and received a deviating colostomy due to obstructing colorectal cancer between January 2011 and December 2015 in five Swedish hospitals in Region Västra Götaland were included (n = 289). Patient charts were reviewed retrospectively. Patients alive in the end of 2016 were contacted and were sent a questionnaire including questions about stoma function and health-related quality of life. RESULTS: Some 289 patients were included; 147 received an end colostomy and 140 a loop colostomy. Two patients were excluded from the analysis due to missing data. There was no difference in complications at 90 days between the two groups, 44% (end colostomy) and 54% (loop colostomy) (odds ratio: 0.83 (95% CI: 0.49; 1.41). Time to start of treatment was similar in both groups. Patients with a loop colostomy had significantly higher stoma-related morbidity with retraction, prolapse, leakage and bandaging problems. No differences in quality of life were found. CONCLUSION: The hypothesis that a loop colostomy reduced complications could not be confirmed. An end colostomy should be the first choice in these patients particularly in patients who will have their colostomy for the remainder of their life to reduce stoma-related symptoms.

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.

Early closure of temporary ileostomy--the EASY trial: protocol for a randomised controlled trial.

OBJECTIVE: The objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal). BACKGROUND: Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7-9% and minor complications varying from 4-5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality. DESIGN AND METHODS: Early closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0-12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation). DISCUSSION: The aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637.