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

This study has been completed.
Sponsor:
Collaborators:
Dutch Digestive Diseases Foundation (Maag Lever Darm Stichting: MLDS)
Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT00956241
First received: August 10, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Rectal Cancer
Procedure: j-pouch coloanal anastomosis
Procedure: side-to-end coloanal anastomosis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Function of the neo-rectum as assessed by the functional outcome questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Surgical results [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: April 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00956241

Locations
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Digestive Diseases Foundation (Maag Lever Darm Stichting: MLDS)
Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
  More Information

No publications provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A. Doeksen, MLDS
ClinicalTrials.gov Identifier: NCT00956241     History of Changes
Other Study ID Numbers: WS 01-62
Study First Received: August 10, 2009
Last Updated: August 10, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
rectal cancer
colonic pouch
side-to-end anastomosis
preoperative radiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014