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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01196000
Collaborator
(none)
0
Enrollment
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: conventional laparoscopic surgery
  • Procedure: robotic-assisted laparoscopic surgery
  • Procedure: quality-of-life assessment
  • Other: questionnaire administration
 N/A

Detailed Description

OBJECTIVES:

  1. To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial.

  2. To assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation.

  3. To assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins.

  4. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform NHS and other service providers and decision-makers.

  5. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
Study Start Date :
Dec 1, 2011
Anticipated Primary Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I

Patients undergo standard conventional laparoscopic resection.

Procedure: conventional laparoscopic surgery
operation using conventional laparoscopic techniques
Other Names:
  • laparoscopy-assisted surgery
  • surgery, laparoscopic

    • Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment

    • Other: questionnaire administration
    Ancillary studies
    Experimental: Arm II

    Patients undergo robotic-assisted laparoscopic resection.

    Procedure: robotic-assisted laparoscopic surgery
    operation that involves use of laparoscopic assistance with robotic assistance

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment

    • Other: questionnaire administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Rate of conversion to open surgery as an indicator of surgical technical difficulty [At completion of surgery]

    Secondary Outcome Measures

    1. Circumferential resection margin positivity rate [At completion of pathology review]

    2. Local recurrence rate [At 3 years]

    3. Intra-operative and post-operative complications [At day 30 and 6 months]

    4. Operative mortality [At day 30]

    5. Self reported bladder and sexual function [At day 30 and 6 months]

    6. Health related quality of life [At day 30 and 6 months]

    7. Disease free and overall survival [At 3 years]

    8. Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS) [Upon completion of GOALS assessment by an independent expert]

    9. Quality of the plane of surgery as assessed by central review of photographs [At completion of the central review of photographs]

    10. Health economics [At day 30 and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • City of Hope Medical Center

    Investigators

    • Principal Investigator: Alessio Pigazzi, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT01196000
    Other Study ID Numbers:
    • 07158
    • NCI-2010-01427
    First Posted:
    Sep 8, 2010
    Last Update Posted:
    Apr 17, 2012
    Last Verified:
    Apr 1, 2012
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Apr 17, 2012