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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956241
• Other study ID #: WS 01-62
• 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

• Rectal Cancer
• Rectal Neoplasms

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