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Completed

NCT Number: NCT00956241

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

j-pouch coloanal anastomosis

Procedure

side-to-end coloanal anastomosis

Procedure

Primary outcomes

  1. Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.

    Time frame: 4 months

Secondary outcomes

  1. Function of the neo-rectum as assessed by the functional outcome questionnaire

    Time frame: 12 months

  2. Surgical results

    Time frame: 4 and 12 months

  3. Quality of life

    Time frame: 4 and 12 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Aug 11, 2009
Registry last updated
Aug 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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