Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis
This is a randomized, multicenter study. Patients are stratified according to participating
center, gender, distance of the distal tumor margin from the dentate line (> 5 cm vs ≤ 5
cm), age (< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis
(M0 vs M1). Patients are randomized to 1 of 3 treatment arms.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Composite evacuation score after total mesorectal excision
12 months after surgery
No
Christian T. Hamel, MD
Study Chair
Kantonsspital - Abteilung Onkologie
Switzerland: Ethical Committees
SAKK 40/04
NCT00238381
July 2005
December 2015
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