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Brief Title: Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
Official Title: 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
Study ID: NCT00238381
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kreiskrankenhaus Lörrach, Lörrach, , Germany
Kantonsspital Aarau, Aarau, , Switzerland
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
Kantonsspital Luzern, Luzerne, , Switzerland
Ospedale Beata Vergine, Mendrisio, , Switzerland
Kantonsspital Olten, Olten, , Switzerland
GZO Spital Wetzikon, Wetzikon, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Klinik Hirslanden, Zurich, , Switzerland
City Hospital Triemli, Zurich, , Switzerland
UniversitaetsSpital Zuerich, Zurich, , Switzerland
Name: Christian T. Hamel, MD
Affiliation: Kantonsspital - Abteilung Onkologie
Role: STUDY_CHAIR
Name: Walter R. Marti, Prof.
Affiliation: Kantonsspital Aarau
Role: STUDY_CHAIR
Name: Markus Zuber, MD
Affiliation: Kantonsspital Olten
Role: STUDY_CHAIR