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Spots Global Cancer Trial Database for Early Reversal of Defunctioning Stoma Trial

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Trial Identification

Brief Title: Early Reversal of Defunctioning Stoma Trial

Official Title: Early Reversal of Defunctioning Stoma Trial

Study ID: NCT00640913

Conditions

Rectal Cancer

Study Description

Brief Summary: 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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Surgery, Örebro University Hospital, Örebro, , Sweden

Contact Details

Name: Peter Matthiessen, MD, PhD

Affiliation: Department of Surgery, Örebro University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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