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)127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

127

Conditions

Rectal Cancer

Interventions

j-pouch coloanal anastomosisPROCEDURE

side-to-end coloanal anastomosisPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Academic Medical Center

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 4 months

Secondary Outcomes

Function of the neo-rectum as assessed by the functional outcome questionnaire

Time frame: 12 months

Surgical results

Time frame: 4 and 12 months

Quality of life

Time frame: 4 and 12 months

Data from ClinicalTrials.gov

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