ROLARR: Robotic versus Laparoscopic Resection for Rectal Cancer

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Scientific Abstract|Design: Multicentre, prospective, randomised, controlled, parallel-group trial of robotic-assisted versus laparoscopic surgery for the curative treatment of rectal cancer. The setup is designed on a hub-spoke-site basis with regional spokes in USA, Singapore, and Leeds feeding into the central CTRU. Patients will be randomised on an equal basis to either laparoscopic or robotic-assisted surgery. Randomisation will be stratified according to participating surgeon, patient sex, neoadjuvant therapy (yes or no), and nature of proposed procedure (high or low anterior resection or abdominoperineal resection). |Setting: Teaching Hospital (or their equivalent) with expertise in laparoscopic and robotic rectal cancer surgery and clinical trial involvement, and can guarantee ~15 patients/year. |Target population: Male or female aged 18+ years and able to provide written informed consent, with diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection. |Interventions being evaluated: Pre- and post-operative care will be as per institutional protocol. Robotic surgery may be by a totally robotic or a hybrid approach; the only absolute requirement is for robotic TME rectal resection. The specifics of each operation will be at the discretion of the surgeon, as will the decision to convert to open operation. Laparoscopic TME will be performed in accordance with each surgeons usual practice. |Measurement of outcomes and duration of follow up: The treatment period constitutes the surgical period only. Clinical follow-up data will be collected by review at 30 days, 6 & 12 months post-operatively & annually thereafter until 3-years post-randomisation. Bladder and sexual function and QoL data will be measured at baseline and 6 months (and at 30 days for the Euroqol-5D (EQ-5D)). |Primary outcome: Conversion rates: conversion to open surgery (as an indicator of technical difficulty). Conversion is defined as the need to use a laparotomy wound for any reason other than specimen retrieval. |Key secondary outcomes are as follows: 1) Circumferential resection margin (CRM) positivity rates: pathological resection margin positivity rates, with CRM as the key outcome measure, will be collected as an indicator of oncological efficacy. 2) 3-year local disease recurrence rates: as a key survival outcome and indicator of surgical accuracy. |Further secondary outcomes: 3) Technical safety: intra- and post-operative complications and 30-day mortality. A complication will be defined as an adverse event and will include both minor (not requiring intervention) and major (requiring intervention) events. 4) Functional outcomes: Bladder & sexual function assessed by International Prostatic Symptom Score (IPSS) for male and female bladder function, and the International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI) for sexual function. 5) Generic health-related quality of life assessed by Short-Form 36 (SF-36). 6) Recurrence and survival: 3-year disease-free and overall survival. 7) Health economics: a within-trial economic evaluation utilising resource use and outcome data from all centres. Costs will be based upon UK NHS costs. The impact of differential rates of technological diffusion on cost effectiveness will be explored using a series of scenario analyses. Methods of analysis will adhere to NICE reference case where possible. 8) Global assessment tool for evaluation of intra-operative laparoscopic skills GOALS. To assess technical competency investigators will submit a video of mesorectal dissections from randomly selected cases (reflecting early and late cases) for review by an independent, blinded expert and assigned a GOALS score. 9) Pathology assessment of the plane of surgery. Blinded assessment will score the quality of the plane of surgery for both surgical arms of the trial.|Sample size: The primary endpoint is conversion to open rectal resection;