Status:
WITHDRAWN
Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery
Lead Sponsor:
City of Hope Medical Center
Conditions:
Recurrent Rectal Cancer
Stage I Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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-assi...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01196000
Start Date
December 1 2011
Last Update
April 17 2012
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