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

August 29, 2017 updated by: Kantonsspital Liestal

Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Baselland
      • Liestal, Baselland, Switzerland, 4410
        • Kantonspital Baselland Liestal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 2 weeks
Ileostomy closure after 2 weeks
Procedure: Ileostomy closure
Ileostomy closure at a different time point
EXPERIMENTAL: 12 weeks
Ileostomy closure after 12 weeks
Procedure: Ileostomy closure
Ileostomy closure at a different time point

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality Of Life (GQLI - Questionnaire)
Time Frame: 6 weeks
Quality Of Life Survey using the GQLI - Questionnaire
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (via Visual Analogue Scale)
Time Frame: intraoperatively
Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter
intraoperatively
Safety as assessed by Morbidity, Mortality
Time Frame: 6 weeks, 16 weeks
Morbidity, Mortality
6 weeks, 16 weeks
Quality Of Life (EORTC - Questionnaire)
Time Frame: preoperative (preOP), 6 weeks, 16 weeks
Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire
preoperative (preOP), 6 weeks, 16 weeks
Quality Of Life (GQLI - Questionnaire)
Time Frame: preOP, 16 weeks
Quality Of Life Survey using the GQLI - Questionnaire
preOP, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Liestal

Investigators

  • Principal Investigator: Christoph A. Maurer, Prof.Dr.med., Kantonsspital Baselland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (ESTIMATE)

November 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB-REF-NR-266/07_Ileostomy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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