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

NCT ID: NCT01196000

Last Updated: 2012-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

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.

Conditions

Recurrent Rectal Cancer; Stage I Rectal Cancer; Stage II Rectal Cancer; Stage III Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients undergo standard conventional laparoscopic resection.

Group Type: ACTIVE_COMPARATOR

conventional laparoscopic surgery

Intervention Type: PROCEDURE

operation using conventional laparoscopic techniques

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Arm II

Patients undergo robotic-assisted laparoscopic resection.

Group Type: EXPERIMENTAL

robotic-assisted laparoscopic surgery

Intervention Type: PROCEDURE

operation that involves use of laparoscopic assistance with robotic assistance

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

conventional laparoscopic surgery

operation using conventional laparoscopic techniques

Intervention Type: PROCEDURE

robotic-assisted laparoscopic surgery

operation that involves use of laparoscopic assistance with robotic assistance

Intervention Type: PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

laparoscopy-assisted surgery; surgery, laparoscopic; quality of life assessment

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessio Pigazzi

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Other Identifiers

NCI-2010-01427

Identifier Type: -

Identifier Source: secondary_id

07158

Identifier Type: -

Identifier Source: org_study_id