Status:

COMPLETED

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

Lead Sponsor:

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

Collaborating Sponsors:

Dutch Digestive Diseases Foundation

Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).

Conditions:

Rectal Cancer

Eligibility:

All Genders

Phase:

NA

Brief Summary

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.

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 th...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2007

Estimated Enrollment :

127 Patients enrolled

Trial Details

Trial ID

NCT00956241

Start Date

April 1 2002

End Date

January 1 2007

Last Update

August 11 2009

Active Locations (1)

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Academic Medical Center

Amsterdam, Netherlands, 1105 AZ