Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion
- Able to provide written informed consent
- Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by CT and MRI or transrectal ultrasound)
- Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
- Fit for robotic-assisted or standard laparoscopic rectal resection
- ASA =< 3
- Capable of completing required questionnaires at time of consent
Exclusion
- Benign lesions of the rectum
- Cancers of the anal canal
- Locally advanced cancers not amenable to curative surgery
- Locally advanced cancers requiring en bloc multi-visceral resection
- Synchronous colorectal tumours requiring multi-segment surgical resection
- Co-existent inflammatory bowel disease
- Clinical or radiological evidence of metastatic spread
- Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with Chief Investigator via CTRU)
- History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
- Pregnancy
- Participation in another rectal cancer clinical trial relating to surgical technique
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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