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

N/AWithdrawnNCT01196000

City of Hope Medical Center

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

conventional laparoscopic surgeryPROCEDURE

operation using conventional laparoscopic techniques

robotic-assisted laparoscopic surgeryPROCEDURE

operation that involves use of laparoscopic assistance with robotic assistance

quality-of-life assessmentPROCEDURE

Ancillary studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of conversion to open surgery as an indicator of surgical technical difficulty

Time frame: At completion of surgery

Secondary Outcomes

Circumferential resection margin positivity rate

Time frame: At completion of pathology review

Local recurrence rate

Time frame: At 3 years

Intra-operative and post-operative complications

Time frame: At day 30 and 6 months

Operative mortality

Time frame: At day 30

Self reported bladder and sexual function

Time frame: At day 30 and 6 months

Health related quality of life

Time frame: At day 30 and 6 months

Disease free and overall survival

Time frame: 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)

Time frame: Upon completion of GOALS assessment by an independent expert

Quality of the plane of surgery as assessed by central review of photographs

Time frame: At completion of the central review of photographs

Health economics

Time frame: At day 30 and 6 months

Data from ClinicalTrials.gov

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