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

Karolinska University Hospital

Status: Enrolling

Conditions: Rectal Neoplasm

Treatments: Procedure: Stapled or Hand-sewn anastomosis; Procedure: Mesh or suture stoma site closure

Study type: Interventional

Funder types: Other

Identifiers

NCT02669992

2015/321-31/1

Details and patient eligibility

About

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?

Full 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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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400 participants in 4 patient groups

Stapled anastomosis

Experimental group

Description:

Stapled anastomosis by the use of commercially available linear stapler device

Treatment:

Procedure: Stapled or Hand-sewn anastomosis

Hand-sewn anastomosis

Active Comparator group

Description:

Hand-sewn by the use of a resorbable monofilament suture

Treatment:

Procedure: Stapled or Hand-sewn anastomosis

Abdominal wall mesh closure

Experimental group

Description:

Closure by the use of a mesh low-weight net device

Treatment:

Procedure: Mesh or suture stoma site closure

Abdominal wall suture closure

Active Comparator group

Description:

Closure by the use of slowly absorbing monofilament suture

Treatment:

Procedure: Mesh or suture stoma site closure