Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

NCT ID: NCT02609451

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2 weeks

Ileostomy closure after 2 weeks

Group Type EXPERIMENTAL

Ileostomy closure

Intervention Type PROCEDURE

Ileostomy closure at a different time point

12 weeks

Ileostomy closure after 12 weeks

Group Type EXPERIMENTAL

Ileostomy closure

Intervention Type PROCEDURE

Ileostomy closure at a different time point

Interventions

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Ileostomy closure

Ileostomy closure at a different time point

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Liestal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph A. Maurer, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hosptal, Baselland

Locations

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Kantonspital Baselland Liestal

Liestal, Basel-Landschaft, Switzerland

Site Status

Countries

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Switzerland

References

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Thalheimer A, Bueter M, Kortuem M, Thiede A, Meyer D. Morbidity of temporary loop ileostomy in patients with colorectal cancer. Dis Colon Rectum. 2006 Jul;49(7):1011-7. doi: 10.1007/s10350-006-0541-2.

Reference Type BACKGROUND
PMID: 16598401 (View on PubMed)

O'Leary DP, Fide CJ, Foy C, Lucarotti ME. Quality of life after low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. Br J Surg. 2001 Sep;88(9):1216-20. doi: 10.1046/j.0007-1323.2001.01862.x.

Reference Type BACKGROUND
PMID: 11531870 (View on PubMed)

Hallbook O, Matthiessen P, Leinskold T, Nystrom PO, Sjodahl R. Safety of the temporary loop ileostomy. Colorectal Dis. 2002 Sep;4(5):361-364. doi: 10.1046/j.1463-1318.2002.00398.x.

Reference Type BACKGROUND
PMID: 12780582 (View on PubMed)

Elsner AT, Brosi P, Walensi M, Uhlmann M, Egger B, Glaser C, Maurer CA. Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial. Dis Colon Rectum. 2021 Nov 1;64(11):1398-1406. doi: 10.1097/DCR.0000000000002182.

Reference Type DERIVED
PMID: 34343161 (View on PubMed)

Other Identifiers

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EKBB-REF-NR-266/07_Ileostomy

Identifier Type: -

Identifier Source: org_study_id

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