Early Reversal of Defunctioning Stoma Trial (ELSOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Rectal Cancer Trial on Defunctioning Stoma Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rectal Cancer Trial on Defunctioning Stoma Study Group
ClinicalTrials.gov Identifier:
NCT00640913
First received: March 10, 2008
Last updated: March 19, 2008
Last verified: March 2008

March 10, 2008
March 19, 2008
February 2008
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00640913 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Early Reversal of Defunctioning Stoma Trial
Early Reversal of Defunctioning Stoma Trial

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Analysis of serum C-Reactive Protein (CRP) and Procalcitonin (PCT).

Non-Probability Sample

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

Rectal Cancer
Procedure: Reversal of defunctioning stoma
Reversal of defunctioning stoma
I
Twenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation.
Intervention: Procedure: Reversal of defunctioning stoma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
November 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Peter Matthiessen, MD, PhD 0046 19 602 20 76 peter.matthiessen@orebroll.se
Sweden
 
NCT00640913
Ö 109-07
Yes
Peter Matthiessen, MD, PhD, Department of Surgery, Örebro University Hospital, 701 85 Örebro
Rectal Cancer Trial on Defunctioning Stoma Study Group
Not Provided
Principal Investigator: Peter Matthiessen, MD, PhD Department of Surgery, Örebro University Hospital
Rectal Cancer Trial on Defunctioning Stoma Study Group
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP