Early Reversal of Defunctioning Stoma Trial
18 Years
85 Years
Both
Rectal Cancer
Trial Information
Early Reversal of Defunctioning Stoma Trial
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
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
Outcome Time Frame:
Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively
Safety Issue:
Yes
Principal Investigator
Peter Matthiessen, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Surgery, Örebro University Hospital
Authority:
Sweden: Regional Ethical Review Board
Study ID:
Ö 109-07
NCT ID:
NCT00640913
Start Date:
February 2008
Completion Date:
November 2009
Related Keywords:
- Rectal Cancer
- Defunctioning stoma
- Low anterior resection
- TME surgery
- Early stoma reversal
- Rectal Neoplasms
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