a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer.
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000039169
- Lead Sponsor
- ational cancer center east hospital colorectal surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1104
Not provided
1) T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour, determined by MRIscan (staged after (chemo)radiotherapy if applicable) 2) Intention for APR 3) Malignancy other than adenocarcinoma at histological examination 4) Patients under 18 years of age 5) Pregnancy 6) Previous prostate or rectal surgery (excluding local excision) 8) Signs of acute intestinal obstruction 9) Multiple colorectal tumors 11) Planned synchronous abdominal organ resections 12) Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri 10) Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis 13) Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as sever cardiovascular or respiratory disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method