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

Last updated: January 25, 2023
Sponsor: Karolinska University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Colon Cancer; Rectal Cancer

Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT02669992
2015/321-31/1
  • All Genders

Study Summary

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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • patient unable to understand written or oral information

Study Design

Total Participants: 400
Study Start date:
June 01, 2015
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Sahlgrenska Universitetssjukhuset, Östra sjukhuset

    Goteborg,
    Sweden

    Active - Recruiting

  • Centralsjukhuset Karlstad

    Karlstad,
    Sweden

    Active - Recruiting

  • Sunderby Sjukhus

    Lulea,
    Sweden

    Active - Recruiting

  • Lycksele lasarett

    Lycksele,
    Sweden

    Active - Recruiting

  • Skanes Universitetssjukhus Malmö

    Malmo,
    Sweden

    Site Not Available

  • Norrtälje sjukhus

    Norrtälje,
    Sweden

    Active - Recruiting

  • Östersundssjukhus

    Ostersund,
    Sweden

    Site Not Available

  • Skellefteå lasarett

    Skellefteå,
    Sweden

    Active - Recruiting

  • Danderyds sjukhus

    Stockholm,
    Sweden

    Active - Recruiting

  • Karolinska universitetssjukhuset

    Stockholm,
    Sweden

    Active - Recruiting

  • Norrlands Universitets Sjukhus

    Umea,
    Sweden

    Active - Recruiting

  • Region Gotland

    Visby, 62149
    Sweden

    Active - Recruiting

  • Östersunds sjukhus

    Östersund,
    Sweden

    Active - Recruiting

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