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

This study has been withdrawn prior to enrollment.
(The study has never been opened to accrual at COH. Study to be closed at COH due to the lack of qualified robotic colorectal surgeons.)
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01196000
First received: September 3, 2010
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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 Intervention
Recurrent Rectal Cancer
Stage I Rectal Cancer
Stage II Rectal Cancer
Stage III Rectal Cancer
Procedure: conventional laparoscopic surgery
Procedure: robotic-assisted laparoscopic surgery
Procedure: quality-of-life assessment
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Rate of conversion to open surgery as an indicator of surgical technical difficulty [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Circumferential resection margin positivity rate [ Time Frame: At completion of pathology review ] [ Designated as safety issue: No ]
  • Local recurrence rate [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Intra-operative and post-operative complications [ Time Frame: At day 30 and 6 months ] [ Designated as safety issue: No ]
  • Operative mortality [ Time Frame: At day 30 ] [ Designated as safety issue: No ]
  • Self reported bladder and sexual function [ Time Frame: At day 30 and 6 months ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: At day 30 and 6 months ] [ Designated as safety issue: No ]
  • Disease free and overall survival [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS) [ Time Frame: Upon completion of GOALS assessment by an independent expert ] [ Designated as safety issue: No ]
  • Quality of the plane of surgery as assessed by central review of photographs [ Time Frame: At completion of the central review of photographs ] [ Designated as safety issue: No ]
  • Health economics [ Time Frame: At day 30 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: quality of life assessment
Other: questionnaire administration
Ancillary studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196000

Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Alessio Pigazzi Beckman Research Institute
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01196000     History of Changes
Other Study ID Numbers: 07158, NCI-2010-01427
Study First Received: September 3, 2010
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 20, 2014