Early Reversal of Defunctioning Stoma Trial (ELSOR)
Recruitment status was Recruiting
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Early Reversal of Defunctioning Stoma Trial|
- 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 ] [ Designated as safety issue: Yes ]
- Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months. [ Time Frame: Postoperatively at 1 and 6 months. ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Analysis of serum C-Reactive Protein (CRP) and Procalcitonin (PCT).
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640913
|Contact: Peter Matthiessen, MD, PhD||0046 19 602 20 firstname.lastname@example.org|
|Department of Surgery, Örebro University Hospital||Recruiting|
|Örebro, Sweden, 701 85|
|Contact: Rickard Lindgren, MD 0046 19 602 10 00 email@example.com|
|Principal Investigator:||Peter Matthiessen, MD, PhD||Department of Surgery, Örebro University Hospital|