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


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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

4 months

Safety Issue:

No

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

WS 01-62

NCT ID:

NCT00956241

Start Date:

April 2002

Completion Date:

January 2007

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • colonic pouch
  • side-to-end anastomosis
  • preoperative radiotherapy
  • Rectal Neoplasms

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