J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer

August 10, 2009 updated by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial

The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Invalidating anorectal dysfunctions are common after restorative rectal surgery. Improvement of functional results by the technically more demanding J-pouch has been demonstrated in comparison with the straight coloanal anastomosis. In the present multicenter randomized trial we assessed whether the J-pouch is also superior to the side-to-end coloanal anastomosis.

Study Type

Interventional

Enrollment (Actual)

127

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

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The inclusion criteria comprised a histologically proven rectal cancer located in the middle or distal part of the rectum (≤ 10cm from the anal verge), and a WHO performance status ≤ 2.

Exclusion Criteria:

  • Patients with a T1 or T4 tumor were excluded
  • Patients diagnosed with distant metastases
  • A medical history of colonic resection
  • Anorectal surgery or chemo- radiotherapy
  • Pre-existing fecal incontinence grade III or IV according to Parks10
  • Life expectancy of less than one year.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: j-pouch coloanal anastomosis
although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.
Procedure: j-pouch coloanal anastomosis
Other: side-to-end coloanal anastomosis
in the Netherlands, the side-to-end anastomosis is the standard procedure to perform an anastomosis in case of rectal resection. therefore, the side-to-end group was our control group
Procedure: side-to-end coloanal anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Function of the neo-rectum as assessed by the functional outcome questionnaire
Time Frame: 12 months
12 months
Surgical results
Time Frame: 4 and 12 months
4 and 12 months
Quality of life
Time Frame: 4 and 12 months
4 and 12 months

Collaborators and Investigators

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Dutch Digestive Diseases Foundation
Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).

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

April 1, 2002

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2009

Last Update Submitted That Met QC Criteria

August 10, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS 01-62

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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