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

Primary Purpose

Rectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ileostomy closure
Sponsored by
Kantonsspital Liestal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring quality of life, feasibility, safety, protective ileostomy closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kantonspital Baselland Liestal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2 weeks

12 weeks

Arm Description

Ileostomy closure after 2 weeks

Ileostomy closure after 12 weeks

Outcomes

Primary Outcome Measures

Quality Of Life (GQLI - Questionnaire)
Quality Of Life Survey using the GQLI - Questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2015
Last Updated
August 29, 2017
Sponsor
Kantonsspital Liestal
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1. Study Identification

Unique Protocol Identification Number
NCT02609451
Brief Title
Closure of Protective Ileostomy 2 vs. 12 Weeks After TME
Acronym
Closure2vs12
Official Title
Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Evidence of bad outcome after interims analysis
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Liestal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
quality of life, feasibility, safety, protective ileostomy closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 weeks
Arm Type
Experimental
Arm Description
Ileostomy closure after 2 weeks
Arm Title
12 weeks
Arm Type
Experimental
Arm Description
Ileostomy closure after 12 weeks
Intervention Type
Procedure
Intervention Name(s)
Ileostomy closure
Intervention Description
Ileostomy closure at a different time point
Primary Outcome Measure Information:
Title
Quality Of Life (GQLI - Questionnaire)
Description
Quality Of Life Survey using the GQLI - Questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Feasibility (via Visual Analogue Scale)
Description
Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter
Time Frame
intraoperatively
Title
Safety as assessed by Morbidity, Mortality
Description
Morbidity, Mortality
Time Frame
6 weeks, 16 weeks
Title
Quality Of Life (EORTC - Questionnaire)
Description
Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire
Time Frame
preoperative (preOP), 6 weeks, 16 weeks
Title
Quality Of Life (GQLI - Questionnaire)
Description
Quality Of Life Survey using the GQLI - Questionnaire
Time Frame
preOP, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph A. Maurer, Prof.Dr.med.
Organizational Affiliation
Cantonal Hosptal, Baselland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonspital Baselland Liestal
City
Liestal
State/Province
Baselland
ZIP/Postal Code
4410
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16598401
Citation
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.
Results Reference
background
PubMed Identifier
11531870
Citation
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.
Results Reference
background
PubMed Identifier
12780582
Citation
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.
Results Reference
background
PubMed Identifier
34343161
Citation
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.
Results Reference
derived

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Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

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