NCT02609451

Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Kantonsspital Liestal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.

Detailed description

In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Ileostomy closure	Ileostomy closure at a different time point

Timeline

• Start date: 2007-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2015-11-20
• Last updated: 2017-08-31

Locations

1 site across 1 country: Switzerland