Back to resultsRectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5 cm colon-J-pouch
side-to-end anastomosis
straight coloanal anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the rectum, stage 0 rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent rectal cancer
Eligibility Criteria
Histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy Total mesorectal excision needed Age ≥ 18 years Clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools) Any T, any N, any M or adenoma An R0-resection is expected (liver metastases planned to be simultaneously Written informed consent, signed and dated by the patient and the investigator Completed baseline quality of life questionnaire Exclusion criteria: 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)
Sites / Locations
- Kreiskrankenhaus Lörrach
- Kantonsspital Aarau
- Zuger Kantonsspital AG
- Universitaetsspital-Basel
- Inselspital Bern
- Kantonsspital Bruderholz
- Bezirksspital Dornach
- Hopitaux Universitaires de Geneve
- Hopital de La Chaux-de-Fonds
- Centre Hospitalier Universitaire Vaudois
- Kantonsspital Luzern
- Ospedale Beata Vergine
- Kantonsspital Olten
- GZO Spital Wetzikon
- Kantonsspital Winterthur
- Klinik Hirslanden
- City Hospital Triemli
- UniversitaetsSpital Zuerich
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Arm I
Arm II
Arm III
Arm Description
Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
Outcomes
Primary Outcome Measures
Composite evacuation score after total mesorectal excision
Secondary Outcome Measures
Composite evacuation score at 6, 18, and 24 months after total mesorectal excision
Composite incontinence score after total mesorectal excision
Quality of life after total mesorectal excision
Overall survival
Morbidity
Full Information
NCT ID
NCT00238381
First Posted
October 12, 2005
Last Updated
May 14, 2019
Sponsor
Swiss Group for Clinical Cancer Research
1. Study Identification
Unique Protocol Identification Number
NCT00238381
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 Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma of the rectum, stage 0 rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
336 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Other
Arm Description
Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
Arm Title
Arm II
Arm Type
Other
Arm Description
Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
Arm Title
Arm III
Arm Type
Other
Arm Description
Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
Intervention Type
Procedure
Intervention Name(s)
5 cm colon-J-pouch
Intervention Description
5 cm colon-J-pouch with/without temporary protective ileostomy
Intervention Type
Procedure
Intervention Name(s)
side-to-end anastomosis
Intervention Description
side-to-end anastomosis with/without temporary protective ileostomy
Intervention Type
Procedure
Intervention Name(s)
straight coloanal anastomosis
Intervention Description
straight coloanal anastomosis with/without temporary protective ileostomy
Primary Outcome Measure Information:
Title
Composite evacuation score after total mesorectal excision
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Composite evacuation score at 6, 18, and 24 months after total mesorectal excision
Time Frame
6, 18 and 24 months after surgery
Title
Composite incontinence score after total mesorectal excision
Time Frame
6, 12, 18 and 24 months
Title
Quality of life after total mesorectal excision
Time Frame
6, 12m 18 and 24 months
Title
Overall survival
Time Frame
2 years follow-up
Title
Morbidity
Time Frame
2 years follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy
Total mesorectal excision needed
Age ≥ 18 years
Clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools)
Any T, any N, any M or adenoma
An R0-resection is expected (liver metastases planned to be simultaneously
Written informed consent, signed and dated by the patient and the investigator
Completed baseline quality of life questionnaire
Exclusion criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian T. Hamel, MD
Organizational Affiliation
Kantonsspital - Abteilung Onkologie
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walter R. Marti, Prof.
Organizational Affiliation
Kantonsspital Aarau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Markus Zuber, MD
Organizational Affiliation
Kantonsspital Olten
Official's Role
Study Chair
Facility Information:
Facility Name
Kreiskrankenhaus Lörrach
City
Lörrach
ZIP/Postal Code
79539
Country
Germany
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Zuger Kantonsspital AG
City
Baar
ZIP/Postal Code
6340
Country
Switzerland
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital Bruderholz
City
Bruderholz
ZIP/Postal Code
CH-4101
Country
Switzerland
Facility Name
Bezirksspital Dornach
City
Dornach
ZIP/Postal Code
CH-4143
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneva
ZIP/Postal Code
CH-1226
Country
Switzerland
Facility Name
Hopital de La Chaux-de-Fonds
City
La Chaux-de-Fonds
ZIP/Postal Code
CH 2300
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital Luzern
City
Luzerne
ZIP/Postal Code
CH-6000
Country
Switzerland
Facility Name
Ospedale Beata Vergine
City
Mendrisio
ZIP/Postal Code
CH-6850
Country
Switzerland
Facility Name
Kantonsspital Olten
City
Olten
ZIP/Postal Code
CH-4600
Country
Switzerland
Facility Name
GZO Spital Wetzikon
City
Wetzikon
ZIP/Postal Code
8620
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
CH-8400
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
CH-8063
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30252681
Citation
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.
Results Reference
result
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Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
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