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NCT00640913 Clinical Trial

Early Reversal of Defunctioning Stoma Trial

Rectal Cancer Clinical Trial

— ELSOR  

Official title:
Early Reversal of Defunctioning Stoma Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00640913
Other study ID # Ö 109-07
Secondary ID
Status Recruiting
Phase N/A
First received March 10, 2008
Last updated March 19, 2008
Start date February 2008
Est. completion date November 2009

Study information
Verified date March 2008
Source Rectal Cancer Trial on Defunctioning Stoma Study Group
Contact Peter Matthiessen, MD, PhD
Phone 0046 19 602 20 76
Email peter.matthiessen@orebroll.se
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Reversal of defunctioning stoma
Reversal of defunctioning stoma

Locations
Country Name City State
Sweden Department of Surgery, Örebro University Hospital Örebro

Sponsors (1)
Lead Sponsor Collaborator
Rectal Cancer Trial on Defunctioning Stoma Study Group

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months. Postoperatively at 1 and 6 months. Yes
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