Phase 2 trial of sphincter-preserving operation for low rectal cancer

UMIN ID: UMIN000001161

Registered date:26/05/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 2005/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Performance of anus-preserving operation for patients with low rectal cancer

Outcome(s)

• Primary Outcome: Rate of a successful therapy Mortality rate Three-year local recurrence rate
• Secondary Outcome: Morbidity rate Anal function Three-year disease free survival Rate of patients who avoided permanent stoma Evaluation of QOL

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 76years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: ISR study group
• Source(s) of Monetary Support: This study was supported in part by a Grant-in-Aid for Cancer Research from the Ministry of Health and Welfare and Labor of Japan.