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

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

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: side-to-end coloanal anastomosis; Procedure: j-pouch coloanal anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT00956241

WS 01-62

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups

j-pouch coloanal anastomosis

Other group

Description:

although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.

Treatment:

Procedure: j-pouch coloanal anastomosis

side-to-end coloanal anastomosis

Other group

Description:

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

Treatment:

Procedure: side-to-end coloanal anastomosis