RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery. PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
5 cm colon-J-pouch with/without temporary protective ileostomy
side-to-end anastomosis with/without temporary protective ileostomy
straight coloanal anastomosis with/without temporary protective ileostomy
Kreiskrankenhaus Lörrach
Loerrach, Germany
Kantonsspital Aarau
Aarau, Switzerland
Composite evacuation score after total mesorectal excision
Time frame: 12 months after surgery
Composite evacuation score at 6, 18, and 24 months after total mesorectal excision
Time frame: 6, 18 and 24 months after surgery
Composite incontinence score after total mesorectal excision
Time frame: 6, 12, 18 and 24 months
Quality of life after total mesorectal excision
Time frame: 6, 12m 18 and 24 months
Overall survival
Time frame: 2 years follow-up
Morbidity
Time frame: 2 years follow-up
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Zuger Kantonsspital AG
Baar, Switzerland
Universitaetsspital-Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Kantonsspital Bruderholz
Bruderholz, Switzerland
Bezirksspital Dornach
Dornach, Switzerland
Hopitaux Universitaires de Geneve
Geneva, Switzerland
Hopital de La Chaux-de-Fonds
La Chaux-de-Fonds, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
...and 8 more locations