Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
NCT ID: NCT00238381
Last Updated: 2019-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
336 participants
INTERVENTIONAL
2005-07-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
side-to-end anastomosis
side-to-end anastomosis with/without temporary protective ileostomy
Arm II
Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
5 cm colon-J-pouch
5 cm colon-J-pouch with/without temporary protective ileostomy
Arm III
Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
straight coloanal anastomosis
straight coloanal anastomosis with/without temporary protective ileostomy
Interventions
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5 cm colon-J-pouch
5 cm colon-J-pouch with/without temporary protective ileostomy
side-to-end anastomosis
side-to-end anastomosis with/without temporary protective ileostomy
straight coloanal anastomosis
straight coloanal anastomosis with/without temporary protective ileostomy
Eligibility Criteria
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Exclusion Criteria
* Previous rectal cancer surgery, other than local excision within the last 2 months
* Histologically proven chronic inflammatory bowel disease
* Contraindications to any of the 3 surgical techniques
* BMI \> 35
* Patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the QL questionnaires and/or following the structured interview
* Inability to read and understand any of the languages available on the QL questionnaires,and spoken during the interview (German, French, Italian)
18 Years
ALL
No
Sponsors
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Swiss Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Christian T. Hamel, MD
Role: STUDY_CHAIR
Kantonsspital - Abteilung Onkologie
Walter R. Marti, Prof.
Role: STUDY_CHAIR
Kantonsspital Aarau
Markus Zuber, MD
Role: STUDY_CHAIR
Kantonsspital Olten
Locations
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Kreiskrankenhaus Lörrach
Loerrach, , 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
Countries
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References
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Marti WR, Curti G, Wehrli H, Grieder F, Graf M, Gloor B, Zuber M, Demartines N, Fasolini F, Lerf B, Kettelhack C, Andrieu C, Bigler M, Hayoz S, Ribi K, Hamel C; Swiss Group for Clinical Cancer Research (SAKK), Section Surgery. Clinical Outcome After Rectal Replacement With Side-to-End, Colon-J-Pouch, or Straight Colorectal Anastomosis Following Total Mesorectal Excision: A Swiss Prospective, Randomized, Multicenter Trial (SAKK 40/04). Ann Surg. 2019 May;269(5):827-835. doi: 10.1097/SLA.0000000000003057.
Other Identifiers
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EU-20528
Identifier Type: -
Identifier Source: secondary_id
SAKK 40/04
Identifier Type: -
Identifier Source: org_study_id
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