Closure of Protective Ileostomy 2 vs. 12 Weeks After TME (Closure2vs12)

Kantonsspital Liestal

Status: Terminated

Conditions: Rectal Cancer

Treatments: Procedure: Ileostomy closure

Study type: Interventional

Funder types: Other

Identifiers

NCT02609451

EKBB-REF-NR-266/07_Ileostomy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

2 weeks

Experimental group

Description:

Ileostomy closure after 2 weeks

Treatment:

Procedure: Ileostomy closure

12 weeks

Experimental group

Description:

Ileostomy closure after 12 weeks

Treatment:

Procedure: Ileostomy closure