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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00956241
Other study ID # WS 01-62
Secondary ID
Status Completed
Phase N/A
First received August 10, 2009
Last updated August 10, 2009
Start date April 2002
Est. completion date January 2007

Study information

Verified date August 2009
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
j-pouch coloanal anastomosis

side-to-end coloanal anastomosis


Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam

Sponsors (3)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO)., Dutch Digestive Diseases Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months. 4 months No
Secondary Function of the neo-rectum as assessed by the functional outcome questionnaire 12 months No
Secondary Surgical results 4 and 12 months No
Secondary Quality of life 4 and 12 months No
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