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

K

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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