- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00640913
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 Contact
- Name: Peter Matthiessen, MD, PhD
- Phone Number: 0046 19 602 20 76
- Email: peter.matthiessen@orebroll.se
Study Locations
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-
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Örebro, Sweden, 701 85
- Recruiting
- Department of Surgery, Örebro University Hospital
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Contact:
- Rickard Lindgren, MD
- Phone Number: 0046 19 602 10 00
- Email: rickard.lindgren@orebroll.se
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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.
|
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
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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.
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Postoperatively at 1 and 6 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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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