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.
|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|