Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery
- Conditions
- Recurrent Rectal CancerStage II Rectal CancerStage I Rectal CancerStage III Rectal Cancer
- Interventions
- Procedure: conventional laparoscopic surgeryProcedure: robotic-assisted laparoscopic surgeryProcedure: quality-of-life assessmentOther: questionnaire administration
- Registration Number
- NCT01196000
- Lead Sponsor
- City of Hope Medical Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I questionnaire administration Patients undergo standard conventional laparoscopic resection. Arm II quality-of-life assessment Patients undergo robotic-assisted laparoscopic resection. Arm I conventional laparoscopic surgery Patients undergo standard conventional laparoscopic resection. Arm II robotic-assisted laparoscopic surgery Patients undergo robotic-assisted laparoscopic resection. Arm II questionnaire administration Patients undergo robotic-assisted laparoscopic resection. Arm I quality-of-life assessment Patients undergo standard conventional laparoscopic resection.
- Primary Outcome Measures
Name Time Method Rate of conversion to open surgery as an indicator of surgical technical difficulty At completion of surgery
- Secondary Outcome Measures
Name Time Method Circumferential resection margin positivity rate At completion of pathology review 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 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