Early Reversal of Defunctioning Stoma Trial (ELSOR)

Rectal Cancer Trial on Defunctioning Stoma Study Group

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: Reversal of defunctioning stoma

Study type: Observational

Funder types: Other

Identifiers

NCT00640913

Ö 109-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

I

Description:

Twenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation.

Treatment:

Procedure: Reversal of defunctioning stoma