Phase 2 trial of sphincter-preserving operation for low rectal cancer
Phase 1
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000001161
- Lead Sponsor
- ISR study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients who prefer a standard operation, abdomino-perineal resection. 2. Tumors which were suspected of scirrous invasions. 3. Patients who underwent preoperative therapies such as chemotherapy, radiation, or immunotherapy. 4. Severe anal dysfunction 5. Double cancers. 6. Severe complications such as diabetes, hypertension or pulmonary fibrosis. 7. Patients who have psychogenic disease. 8. Informed consent was not given. 9. Not judged as eligible by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of a successful therapy Mortality rate Three-year local recurrence rate
- Secondary Outcome Measures
Name Time Method Morbidity rate Anal function Three-year disease free survival Rate of patients who avoided permanent stoma Evaluation of QO