Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
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
2 other identifiers
interventional
336
2 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 colorectal-cancer
Started Jul 2005
Longer than P75 for phase_3 colorectal-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedMay 15, 2019
May 1, 2019
8.8 years
October 12, 2005
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite evacuation score after total mesorectal excision
12 months after surgery
Secondary Outcomes (5)
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
Quality of life after total mesorectal excision
6, 12m 18 and 24 months
Overall survival
2 years follow-up
Morbidity
2 years follow-up
Study Arms (3)
Arm I
OTHERPatients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
Arm II
OTHERPatients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
Arm III
OTHERPatients undergo straight coloanal anastomosis with/without temporary protective ileostomy
Interventions
side-to-end anastomosis with/without temporary protective ileostomy
straight coloanal anastomosis with/without temporary protective ileostomy
Eligibility Criteria
You may not qualify if:
- Rectal tumor other than adenocarcinoma or adenoma
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Kreiskrankenhaus Lörrach
Loerrach, 79539, Germany
Kantonsspital Aarau
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
Related Publications (1)
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.
PMID: 30252681RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian T. Hamel, MD
Kantonsspital - Abteilung Onkologie
- STUDY CHAIR
Walter R. Marti, Prof.
Kantonsspital Aarau
- STUDY CHAIR
Markus Zuber, MD
Kantonsspital Olten
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2005
First Posted
October 13, 2005
Study Start
July 1, 2005
Primary Completion
May 1, 2014
Study Completion
August 1, 2016
Last Updated
May 15, 2019
Record last verified: 2019-05