Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
18 Years
N/A
Both
Recurrent Rectal Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer, Stage III Rectal Cancer
Trial Information
Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of conversion to open surgery as an indicator of surgical technical difficulty
Outcome Time Frame:
At completion of surgery
Safety Issue:
No
Principal Investigator
Alessio Pigazzi
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
07158
NCT ID:
NCT01196000
Start Date:
December 2011
Completion Date:
Related Keywords:
- Recurrent Rectal Cancer
- Stage I Rectal Cancer
- Stage II Rectal Cancer
- Stage III Rectal Cancer
- Rectal Neoplasms
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