Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Recurrent Rectal Cancer
- Sponsor
- City of Hope Medical Center
- Primary Endpoint
- Rate of conversion to open surgery as an indicator of surgical technical difficulty
- Status
- Withdrawn
- Last Updated
- 14 years ago
Overview
Brief Summary
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer.
PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.
Detailed Description
OBJECTIVES: I. To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial. II. To assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation. III. To assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins. IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform NHS and other service providers and decision-makers. V. To analyze disease-free and overall survival and local recurrence rates at 3-year follow-up. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo standard laparoscopic resection. ARM II: Patients undergo robotic-assisted laparoscopic resection. After completion of study treatment, patients are followed up at 1 month, 6 months, and then annually thereafter for 3 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of conversion to open surgery as an indicator of surgical technical difficulty
Time Frame: At completion of surgery
Secondary Outcomes
- Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS)(Upon completion of GOALS assessment by an independent expert)
- Health economics(At day 30 and 6 months)
- Circumferential resection margin positivity rate(At completion of pathology review)
- Local recurrence rate(At 3 years)
- Self reported bladder and sexual function(At day 30 and 6 months)
- Health related quality of life(At day 30 and 6 months)
- Intra-operative and post-operative complications(At day 30 and 6 months)
- Operative mortality(At day 30)
- Disease free and overall survival(At 3 years)
- Quality of the plane of surgery as assessed by central review of photographs(At completion of the central review of photographs)