Rectal cancer
Conditions
Interventions
Performance of anus-preserving operation for patients with low rectal cancer
Sponsors
ISR study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Tumors were located below 5cm from anal verge or below 3cm from dentate line. 2. Adenocarcinoma was pathologically proven. 3. T1-T3 4. M0 5. Systemic status which allow the operation. 6. < 76 years old 7. Performance status was 0 or 1. 8. Informed consent was given.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of a successful therapy Mortality rate Three-year local recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity rate Anal function Three-year disease free survival Rate of patients who avoided permanent stoma Evaluation of QOL | — |
Countries
Japan
Contacts
Public ContactMasaaki Ito
National Cancer Center Hospital East Department of colorectal and pelvic surgery
Outcome results
None listed