Early Reversal of Defunctioning Stoma Trial (ELSOR)

March 19, 2008 updated by: Rectal Cancer Trial on Defunctioning Stoma Study Group
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 701 85
        • Recruiting
        • Department of Surgery, Örebro University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty patients operated on with low anterior resection of the rectum for cancer and a defunctioning loop stoma.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months.
Time Frame: Postoperatively at 1 and 6 months.
Postoperatively at 1 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rectal Cancer Trial on Defunctioning Stoma Study Group

Investigators

  • Principal Investigator: Peter Matthiessen, MD, PhD, Department of Surgery, Örebro University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

March 21, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ö 109-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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