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A Randomized Trial on the Technical Aspects of Stoma Construction.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694238
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : March 29, 2019
The Swedish Society of Medicine
The Swedish agreement concerning research and education of doctors
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date  ICMJE September 24, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date March 29, 2019
Study Start Date  ICMJE June 2013
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Stoma hernia frequency at 12 months [ Time Frame: 12 months ]
The frequency of stoma hernia at 12 months measured either by clinical examination or CT scan
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
Stoma hernia frequency at 12 months [ Time Frame: 12 months ]
The frequency of stoma hernia at 12 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
  • Readmission [ Time Frame: 12 months ]
    Number of readmissions in the two groups
  • Postoperative infections [ Time Frame: 12 months ]
    Postoperative infections at 12 months
  • Total hospital stay [ Time Frame: 12 months ]
    The total number of days in hospital during 12 months
  • Other complications [ Time Frame: 12 months ]
    The number and type of complications during 12 months postoperatively
  • 30 day mortality [ Time Frame: 30 days ]
    30 day mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Randomized Trial on the Technical Aspects of Stoma Construction.
Official Title  ICMJE Circular, Mesh Enforced or Cruciate Incision in the Abdominal Wall Fascia for coloStomy Construction - A Randomised Trial
Brief Summary

An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting colostomy for any reason are all included.

The three groups for randomization are:

A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is the parastomal hernia rate within 12 months from index surgery. Secondary end-points include clinical variables, re-admission and/or re-operation due to any stoma complication, quality of life and health economy analyses, at 12 months.

Detailed Description

Colostomy formation has been a standard surgical procedure for more than 100 years. Initially the quality of life for stoma patients was all but good, as the appliances to collect the feces were cumbersome, smelly and did not ensure non-leakage. As late as in the 60-ies bandages were still primitive(1). Gradually these problems have decreased as techniques for bandages have improved. A well functioning colostomy may in itself not negatively affect the patient's Quality of Life (QoL)(2), although thorough information and support from stoma care nurses is of utmost importance (3). However, this can only be said if the stoma is well functioning and if the complications are kept to a minimum. The complication rate after stoma formation is still considerable, with figures of 21-70% (4, 5) and studies have shown that adequate height; type of stoma, BMI, emergency surgery and gender may be of importance in reducing the risk of complications both in the short and long-term (6-8).

The surgical technique of stoma formation is only partly evidence based. There are few studies directed at technical details about stoma construction and their future impact on stoma function, apart from the importance of the stoma height (6). One study has tested to standardize the skin incision to 2/3rds of the width of the bowel (9), although the actual impact of this on the functional outcome of the stoma was not presented.. In the surgical literature a cruciate incision in the fascia and extraction of the bowel through a hole sufficient in size is a short description of the surgical technique (10). In clinical practice sufficient size of the hole has often been equal to "two fingers-width", is commonly used, which refers to the width of the surgeon's fingers, a fairly inexact measurement. A pilot study from Sahlgrenska University Hospital has found that this clinical practice for the most part results in a skin incision diameter of 50% of the bowel width.

There have been discussions regarding the placement of the stoma and effects on hernia incidence, whether in the obliquous muscle or the rectus abdominis (11) or if the bowel should take an extraperitoneal route (ad modum Goligher) or not (12). No studies have been sufficient in design or size to thoroughly answer the question.

Parastomal hernia is a long-term complication that is common, in the literature figures up to almost 50% have been reported (13, 14). Attempts to reduce the rates of parastomal hernias have been made in the last few years with a placement of a mesh, at the construction of the stoma, (15-19). This practice has not been universally accepted, in part due to a hesitance in the surgical society because of the risk of infections with foreign body material, and partly due to that most studies are underpowered for their main outcome variable. Another suggestion for the basic construction of the stoma has been to make a circular incision in the fascia instead of a cruciate, but this has not been documented in any studies. It has been described in conjunction with use of circular stapling devices in the skin, no hernias were found, however the patient numbers were small (20). It is apparent that further studies are most welcome.

The evaluation of parastomal hernias has been discussed. Janes et al. used clinical examination in their studies (16, 17), and confirmed in a later study that the concurrence with a CT-verified parastomal hernia was (21) sufficient if performed in a prone position. Another recent study found that results from a CT-scan was not correlated with patient symptoms (22). Other studies have evaluated the use of ultrasound and found it feasible (23). The conclusion must be that evaluation of parastomal hernias may be difficult and must be standardized in a study.

The hypothesis to be tested in this study is that a circular incision or mesh enforced cruciate incision in the abdominal wall fascia with a diameter of 50% of the width of the patients left colon results carries less risk of parastomal herniation than a cruciate incision where the each of the arms measure 1/2 of the diameter of the patients left colon.

The aim of this trial is to compare the parastomal hernia formation within 12 months after stoma surgery between circular, mesh enforced cruciate and cruciate incision.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colostomy
  • Colorectal Neoplasm
  • Diverticulitis
Intervention  ICMJE
  • Procedure: Cruciate incision
  • Procedure: Circular incision
  • Other: Mesh enforced cruciate incision
Study Arms  ICMJE
  • Active Comparator: Cruciate incision
    Cruciate incision in the abdominal wall fascia
    Intervention: Procedure: Cruciate incision
  • Experimental: Circular incision
    Circular incision in the fascia
    Intervention: Procedure: Circular incision
  • Experimental: Mesh enforced cruciate incision
    Mesh enforcement and then cruciate incision in the abdominal wall fascia
    Intervention: Other: Mesh enforced cruciate incision
Publications * Correa Marinez A, Erestam S, Haglind E, Ekelund J, Angerås U, Rosenberg J, Helgstrand F, Angenete E. Stoma-Const--the technical aspects of stoma construction: study protocol for a randomised controlled trial. Trials. 2014 Jun 27;15:254. doi: 10.1186/1745-6215-15-254.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2012)
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • presenting with a cancer or other conditions for which an elective surgical procedure is planned and includes a permanent colostomy formation
  • possible to operate in regard to concomitant disease
  • giving informed consent to participate

Exclusion Criteria:

  • Not possible to operate due to concomitant disease
  • Participation in other randomized trials in conflict with the protocol and end-points of the Stoma-Const trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01694238
Other Study ID Numbers  ICMJE Stoma-Const
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eva Angenete, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Collaborators  ICMJE
  • The Swedish Society of Medicine
  • The Swedish agreement concerning research and education of doctors
Investigators  ICMJE
Principal Investigator: Eva Angenete, M.D., Ph.D. Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University and SSORG - Scandinavian Surgical Outcomes Research Group
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP