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NCT Number: NCT02669992

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

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?

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Key information

Conditions

Rectal Neoplasm Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska Universitetssjukhuset, Östra sjukhuset, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stapled or Hand-sewn anastomosis

Procedure

Randomization between stapled or hand-sewn anastomosis

Mesh or suture stoma site closure

Procedure

Randomization between suture or Mesh closure of the stoma site

Primary outcomes

  1. 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

  2. Number of participants with postoperative stoma site hernia

    Time frame: 2 year

    Herni postoperatively on the site of previous stoma detected within 2 years

Secondary outcomes

  1. Number of participants with postoperative complications

    Time frame: 30 days

  2. Postoperative Hospital stay

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Pontus Gustafsson, MD

CONTACT

[email protected]

+46703272152

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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.

Acronym: LISTO

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2016
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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