Early Reversal of Defunctioning Stoma Trial

• Conditions: Rectal Cancer
• Interventions: Procedure: Reversal of defunctioning stoma

• Registration Number: NCT00640913
• Lead Sponsor: Rectal Cancer Trial on Defunctioning Stoma Study Group

Brief Summary

In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

Detailed Description

Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.

Study Timeline

• Study Start: 2008-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-19
• Last Update Submitted: 2008-03-19
• Study First Posted: 2008-03-21
• Last Update Posted: 2008-03-21
• Primary Completion: 2009-04
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6.

Exclusion Criteria

• Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
I	Reversal of defunctioning stoma	Twenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation.

Primary Outcome Measures

Name	Time	Method
Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment	Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months.	Postoperatively at 1 and 6 months.

Trial Locations

Locations (1)

Department of Surgery, Örebro University Hospital; 🇸🇪 Örebro, Sweden