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

Recurrent Rectal Cancer Clinical Trial

Official title:

Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01196000
• Other study ID #: 07158
• Secondary ID: NCI-2010-01427
• Status: Withdrawn
• Phase: N/A
• First received: September 3, 2010
• Last updated: April 16, 2012
• Start date: December 2011

Study information

• Verified date: April 2012
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms
• Recurrent Rectal Cancer
• Stage I Rectal Cancer
• Stage II Rectal Cancer
• Stage III Rectal Cancer

Intervention

Procedure:
• conventional laparoscopic surgery
operation using conventional laparoscopic techniques
• robotic-assisted laparoscopic surgery
operation that involves use of laparoscopic assistance with robotic assistance
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of conversion to open surgery as an indicator of surgical technical difficulty		At completion of surgery	No
Secondary	Circumferential resection margin positivity rate		At completion of pathology review	No
Secondary	Local recurrence rate		At 3 years	No
Secondary	Intra-operative and post-operative complications		At day 30 and 6 months	No
Secondary	Operative mortality		At day 30	No
Secondary	Self reported bladder and sexual function		At day 30 and 6 months	No
Secondary	Health related quality of life		At day 30 and 6 months	No
Secondary	Disease free and overall survival		At 3 years	No
Secondary	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	No
Secondary	Quality of the plane of surgery as assessed by central review of photographs		At completion of the central review of photographs	No
Secondary	Health economics		At day 30 and 6 months	No