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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

August 10, 2009
August 10, 2009
April 2002
January 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Rectal Cancer
  • Procedure: j-pouch coloanal anastomosis
  • Procedure: side-to-end coloanal anastomosis
  • 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.
    Intervention: 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
    Intervention: Procedure: side-to-end coloanal anastomosis
Doeksen A, Bakx R, Vincent A, van Tets WF, Sprangers MA, Gerhards MF, Bemelman WA, van Lanschot JJ. J-pouch vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision for rectal cancer: a multicentre randomized trial. Colorectal Dis. 2012 Jun;14(6):705-13. doi: 10.1111/j.1463-1318.2011.02725.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
January 2007
January 2007   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00956241
WS 01-62
Yes
A. Doeksen, MLDS
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).
Not Provided
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP