Clinical trial NCT01196000: Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery
Official title: Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Recurrent Rectal Cancer
Stage I Rectal Cancer
Stage II Rectal Cancer
Stage III Rectal Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Rate of conversion to open surgery as an indicator of surgical technical difficulty
timeFrame: At completion of surgery
Secondary outcomes:
measure: Circumferential resection margin positivity rate
timeFrame: At completion of pathology review
measure: Local recurrence rate
timeFrame: At 3 years
measure: Intra-operative and post-operative complications
timeFrame: At day 30 and 6 months
measure: Operative mortality
timeFrame: At day 30
measure: Self reported bladder and sexual function
timeFrame: At day 30 and 6 months
measure: Health related quality of life
timeFrame: At day 30 and 6 months
measure: Disease free and overall survival
timeFrame: At 3 years
measure: Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS)
timeFrame: Upon completion of GOALS assessment by an independent expert
measure: Quality of the plane of surgery as assessed by central review of photographs
timeFrame: At completion of the central review of photographs
measure: Health economics
timeFrame: At day 30 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Alessio Pigazzi
role: PRINCIPAL_INVESTIGATOR
References: