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

Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer

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.

Study Overview

• Status: Withdrawn
• Conditions: Recurrent Rectal Cancer; Stage I Rectal Cancer; Stage II Rectal Cancer; Stage III Rectal Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: conventional laparoscopic surgery; Procedure: robotic-assisted laparoscopic 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I; Patients undergo standard conventional laparoscopic resection.	Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: conventional laparoscopic surgery; operation using conventional laparoscopic techniques; Other Names: laparoscopy-assisted surgery; surgery, laparoscopic
Experimental: Arm II; Patients undergo robotic-assisted laparoscopic resection.	Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: robotic-assisted laparoscopic surgery; operation that involves use of laparoscopic assistance with robotic assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of conversion to open surgery as an indicator of surgical technical difficulty	At completion of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Circumferential resection margin positivity rate	At completion of pathology review
Local recurrence rate	At 3 years
Intra-operative and post-operative complications	At day 30 and 6 months
Operative mortality	At day 30
Self reported bladder and sexual function	At day 30 and 6 months
Health related quality of life	At day 30 and 6 months
Disease free and overall survival	At 3 years
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
Quality of the plane of surgery as assessed by central review of photographs	At completion of the central review of photographs
Health economics	At day 30 and 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 8, 2010

Study Record Updates

• Last Update Posted (Estimate): April 17, 2012
• Last Update Submitted That Met QC Criteria: April 16, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 07158; NCI-2010-01427