Status:
COMPLETED
Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 a...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00238381
Start Date
July 1 2005
End Date
August 1 2016
Last Update
May 15 2019
Active Locations (18)
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1
Kreiskrankenhaus Lörrach
Loerrach, Germany, 79539
2
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
3
Zuger Kantonsspital AG
Baar, Switzerland, 6340
4
Universitaetsspital-Basel
Basel, Switzerland, CH-4031