Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site? (LISTO)

January 25, 2023 updated by: Ulrik Lindforss, Karolinska University Hospital

Loop Ileostomy Closure.Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site in the Abdominal Wall. A Prospective Randomised Multicenter Trial.

There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions:

  1. The choice of anastomotic method - does it influence the postoperative course?
  2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative complications after closure of a temporary loop ileostomy after rectal cancer surgery are common. In this study the investigators propose the hypothesis that a stapled anastomotic technique will decrease postoperative small bowel obstruction and a mesh closure of the stoma site in the abdominal wall will decrease hernia formation.

All patients will be randomized to stapled or hand-sewn anastomosis. The randomization to mesh or suture closure of the abdominal wall is optional.

The stapled anastomotic technique is performed by the use of a linear staple device and the hand-sewn technique with a running seromuscular monofilament suture.

The stoma site has two options and will be closed either by the use of mesh (lightweight), positioned under the muscle (retromuscular), or just by long-lasting suture. The anterior fascia of the rectus as well as the skin are closed by the use of running monofilament longlasting sutures, the latter in a pursestring procedure.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Goteborg, Sweden
        • Recruiting
        • Sahlgrenska Universitetssjukhuset, Östra sjukhuset
        • Contact:
          • Petra wieveg, MD
      • Karlstad, Sweden
        • Recruiting
        • Centralsjukhuset Karlstad
        • Contact:
          • Claes Erixon
      • Lulea, Sweden
        • Recruiting
        • Sunderby Sjukhus
        • Contact:
          • Christoffer Odensten
      • Lycksele, Sweden
        • Recruiting
        • Lycksele lasarett
      • Norrtälje, Sweden
        • Recruiting
        • Norrtälje Sjukhus
        • Contact:
          • Rebecka Zacharias
      • Skellefteå, Sweden
        • Recruiting
        • Skellefteå lasarett
        • Contact:
          • Mats Hjortborg
      • Stockholm, Sweden
        • Recruiting
        • Danderyds Sjukhus
        • Contact:
          • Ylva Falken, MD
      • Stockholm, Sweden
        • Recruiting
        • Karolinska Universitetssjukhuset
        • Contact:
          • Ulrik Lindforss
      • Umea, Sweden
        • Recruiting
        • Norrlands Universitets sjukhus
        • Contact:
          • Ulf Gunnarsson, prof
      • Visby, Sweden, 62149
      • Östersund, Sweden
        • Recruiting
        • Östersunds Sjukhus
        • Contact:
          • Pär Nordin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • loop ileostomy after rectal cancer surgery
  • loop ileostomy closure is permitted and possible according to clinical practice

Exclusion Criteria:

  • patient unable to understand written or oral information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stapled anastomosis
Stapled anastomosis by the use of commercially available linear stapler device
Procedure: Stapled or Hand-sewn anastomosis
Randomization between stapled or hand-sewn anastomosis
Active Comparator: Hand-sewn anastomosis
Hand-sewn by the use of a resorbable monofilament suture
Procedure: Stapled or Hand-sewn anastomosis
Randomization between stapled or hand-sewn anastomosis
Experimental: Abdominal wall mesh closure
Closure by the use of a mesh low-weight net device
Procedure: Mesh or suture stoma site closure
Randomization between suture or Mesh closure of the stoma site
Active Comparator: Abdominal wall suture closure
Closure by the use of slowly absorbing monofilament suture
Procedure: Mesh or suture stoma site closure
Randomization between suture or Mesh closure of the stoma site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative bowel obstruction
Time Frame: 30 days
Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray
30 days
Number of participants with postoperative stoma site hernia
Time Frame: 2 year
Herni postoperatively on the site of previous stoma detected within 2 years
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with postoperative complications
Time Frame: 30 days
30 days
Postoperative Hospital stay
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Ulrik Lindforss, A.P, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/321-31/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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