Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study
Phase 2
- Conditions
- advanced rectal cancer
- Registration Number
- JPRN-UMIN000039685
- Lead Sponsor
- Sapporo Medical University Hospital Department of surgery, surgical oncology and science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1) cT4b 2) Multiple rectal cancer (except Tis) 3) Multiple malignancies 4) Patients whose consent ability is judged to be insufficient (dementia etc.) 5) Other, patients judged inappropriate by investigators
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of CRM-negative
- Secondary Outcome Measures
Name Time Method Quality of TME successful resection (CRM-negative, DM-negative and complete TME) Conversion to open surgery Intraoperative adverse effects Surgical outcomes (estimate blood loss, operative time, console time, number of lymph nodes harvested) Postoperative recovery of bowel function (time to first flatus/ stools/ intake of fluid and diet) Postoperative urinary function (residual urine volume/ I-PSS/ OABSS/ ICIQ-SF) Length of postoperative hospital stay Postoperative complications within 30 days after surgery (Clavien-Dindo classification grade III or more) Surgery-related mortality within 30 days after surgery Reoperation within 30 days after surgery 3-year local recurrence-free survival 3-year disease-free survival 3-year overall survival