RObotic versus LAparoscopic Resection for Rectal cancer: an international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic assisted versus laparoscopic surgery for the curative treatment of rectal cancer

niversity of Leeds (UK)0 sites466 target enrollmentMay 27, 2010

Overview

Registry

who.int

Start Date

May 27, 2010

End Date

September 30, 2014

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds (UK)

•Current information as of 15/09/2010:
•1\. Aged greater than or equal to 18 years
•2\. Able to provide written informed consent
•3\. Diagnosis of rectal cancer\* amenable to curative surgery either by low anterior resection, high anterior resection, or abdominoperineal resection i.e. staged T1\-3, N0\-2, M0 by imaging as per local practice; although not mandated, CT imaging with either additional MRI or transrectal ultrasound is recommended to assess distant and local disease.
•(\*For the purposes of the ROLARR trial, rectal cancer is defined as an adenocarcinoma whose distal extent is situated at or within 15cm of the anal margin as assessed by endoscopic examination or radiological contrast study)
•4\. Rectal cancer suitable for resection by either standard or robotic\-assisted laparoscopic procedure
•5\. Fit for robotic\-assisted or standard laparoscopic rectal resection
•6\. American Society of Anestheologists (ASA) physical status classification less than or equal to 3
•7\. Capable of completing required questionnaires at time of consent
•Initial information at time of registration:

•Current information as of 15/09/2010:
•1\. Benign lesions of the rectum
•2\. Benign or malignant diseases of the anal canal
•3\. Locally advanced cancers not amenable to curative surgery
•4\. Locally advanced cancers requiring en bloc multi\-visceral resection
•5\. Synchronous colorectal tumours requiring multi\-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
•6\. Co\-existent inflammatory bowel disease
•7\. Clinical or radiological evidence of metastatic spread
•8\. 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 Clinical Trials Research Unit \[CTRU])
•9\. 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