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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Composite evacuation score after total mesorectal excision
Outcome Time Frame:
12 months after surgery
Safety Issue:
No
Principal Investigator
Christian T. Hamel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kantonsspital - Abteilung Onkologie
Authority:
Switzerland: Ethical Committees
Study ID:
SAKK 40/04
NCT ID:
NCT00238381
Start Date:
July 2005
Completion Date:
December 2015
Related Keywords:
- Colorectal Cancer
- 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
- Rectal Neoplasms
- Colorectal Neoplasms
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