Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

NCT02609451 | Terminated

• 1 other identifier: EKBB-REF-NR-266/07_Ileostomy
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

quality of life; feasibility; safety; protective ileostomy closure

Outcome Measures

Primary Outcomes (1)

• Quality Of Life (GQLI - Questionnaire)

  Quality Of Life Survey using the GQLI - Questionnaire

  6 weeks

Secondary Outcomes (4)

• Feasibility (via Visual Analogue Scale)

  intraoperatively

• Safety as assessed by Morbidity, Mortality

  6 weeks, 16 weeks

• Quality Of Life (EORTC - Questionnaire)

  preoperative (preOP), 6 weeks, 16 weeks

• Quality Of Life (GQLI - Questionnaire)

  preOP, 16 weeks

Study Arms (2)

2 weeks

EXPERIMENTAL

Ileostomy closure after 2 weeks

Procedure: Ileostomy closure

12 weeks

EXPERIMENTAL

Ileostomy closure after 12 weeks

Procedure: Ileostomy closure

Interventions

Ileostomy closure PROCEDURE

Ileostomy closure at a different time point

12 weeks; 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kantonsspital Liestal: lead

Study Sites (1)

Kantonspital Baselland Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 16598401 BACKGROUND

• 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.

  PMID: 11531870 BACKGROUND

• 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.

  PMID: 12780582 BACKGROUND

• 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.

  PMID: 34343161 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Christoph A. Maurer, Prof.Dr.med.

  Cantonal Hosptal, Baselland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 31, 2017

Record last verified: 2017-01

Locations

CH (1)