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

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: j-pouch coloanal anastomosis; Procedure: side-to-end coloanal anastomosis

• Registration Number: NCT00956241
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 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.

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2009-08
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Last Update Submitted: 2009-08-10
• Study First Posted: 2009-08-11
• Last Update Posted: 2009-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
j-pouch 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.
side-to-end 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Function of the neo-rectum as assessed by the functional outcome questionnaire	12 months
Surgical results	4 and 12 months
Quality of life	4 and 12 months

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands