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| ID | Type | Description | Link |
|---|---|---|---|
| EU-20528 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Other | Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction. |
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| Arm II | Other | Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction. |
|
| Arm III | Other | Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 cm colon-J-pouch | Procedure | 5 cm colon-J-pouch with/without temporary protective ileostomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite evacuation score after total mesorectal excision | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Composite evacuation score at 6, 18, and 24 months after total mesorectal excision | 6, 18 and 24 months after surgery | |
| Composite incontinence score after total mesorectal excision | 6, 12, 18 and 24 months |
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Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian T. Hamel, MD | Kantonsspital - Abteilung Onkologie | Study Chair |
| Walter R. Marti, Prof. | Kantonsspital Aarau | Study Chair |
| Markus Zuber, MD | Kantonsspital Olten | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kreiskrankenhaus Lörrach | Loerrach | 79539 | Germany | |||
| Kantonsspital Aarau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30252681 | Result | 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. |
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| side-to-end anastomosis |
| Procedure |
side-to-end anastomosis with/without temporary protective ileostomy |
|
| straight coloanal anastomosis | Procedure | straight coloanal anastomosis with/without temporary protective ileostomy |
|
| Quality of life after total mesorectal excision | 6, 12m 18 and 24 months |
| Overall survival | 2 years follow-up |
| Morbidity | 2 years follow-up |
| Aarau |
| CH-5001 |
| Switzerland |
| Zuger Kantonsspital AG | Baar | 6340 | Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | CH-4101 | Switzerland |
| Bezirksspital Dornach | Dornach | CH-4143 | Switzerland |
| Hopitaux Universitaires de Geneve | Geneva | CH-1226 | Switzerland |
| Hopital de La Chaux-de-Fonds | La Chaux-de-Fonds | CH 2300 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital Luzern | Luzerne | CH-6000 | Switzerland |
| Ospedale Beata Vergine | Mendrisio | CH-6850 | Switzerland |
| Kantonsspital Olten | Olten | CH-4600 | Switzerland |
| GZO Spital Wetzikon | Wetzikon | 8620 | Switzerland |
| Kantonsspital Winterthur | Winterthur | CH-8400 | Switzerland |
| Klinik Hirslanden | Zurich | CH-8032 | Switzerland |
| City Hospital Triemli | Zurich | CH-8063 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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