Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

Not Applicable

Terminated

• Conditions: Rectal Cancer
• Interventions: Procedure: Ileostomy closure

• Registration Number: NCT02609451
• Lead Sponsor: Kantonsspital Liestal

Brief 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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Status Verified: 2017-01
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• anastomosis ≤ 5cm from anal verge
• age >18 years
• informed consent
• uneventful course after first operation

Exclusion Criteria

• pregnancy
• allergy to contrast agent
• severe non-surgical complications
• evident abdominal - pelvic complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 weeks	Ileostomy closure	Ileostomy closure after 12 weeks
2 weeks	Ileostomy closure	Ileostomy closure after 2 weeks

Primary Outcome Measures

Name	Time	Method
Quality Of Life (GQLI - Questionnaire)	6 weeks	Quality Of Life Survey using the GQLI - Questionnaire

Secondary Outcome Measures

Name	Time	Method
Safety as assessed by Morbidity, Mortality	6 weeks, 16 weeks	Morbidity, Mortality
Feasibility (via Visual Analogue Scale)	intraoperatively	Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter
Quality Of Life (GQLI - Questionnaire)	preOP, 16 weeks	Quality Of Life Survey using the GQLI - Questionnaire
Quality Of Life (EORTC - Questionnaire)	preoperative (preOP), 6 weeks, 16 weeks	Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire

Trial Locations

Locations (1)

Kantonspital Baselland Liestal; 🇨🇭 Liestal, Baselland, Switzerland