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

NCT02669992 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-01-26

No results posted yet for this 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?

Conditions

  • Rectal Neoplasm

Interventions

PROCEDURE

Stapled or Hand-sewn anastomosis

Randomization between stapled or hand-sewn anastomosis

PROCEDURE

Mesh or suture stoma site closure

Randomization between suture or Mesh closure of the stoma site

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Ulrik Lindforss, A.P · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669992 on ClinicalTrials.gov