NCT01196000

Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery

Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Rectal Cancer
• Stage I Rectal Cancer
• Stage II Rectal Cancer
• Stage III Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	conventional laparoscopic surgery	operation using conventional laparoscopic techniques
PROCEDURE	robotic-assisted laparoscopic surgery	operation that involves use of laparoscopic assistance with robotic assistance
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-07-01
• First posted: 2010-09-08
• Last updated: 2012-04-17