ROLARR: Robotic versus Laparoscopic Resection for Rectal Cancer
Lead Research Organisation:
University of Leeds
Department Name: UNLISTED
Abstract
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Technical Summary
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;
People |
ORCID iD |
David Jayne (Principal Investigator) |
Publications
Randell R
(2019)
Factors supporting and constraining the implementation of robot-assisted surgery: a realist interview study.
in BMJ open
Collinson FJ
(2012)
An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer.
in International journal of colorectal disease
Description | Collaboration with national bodies - ACPGB&I and Bowel Disease Research Foundation |
Organisation | Bowel Disease Research Foundation (BDRF) |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Continued collaborations and negotiations with ACPGB&I and BDRF to promote patient recruitment |
Collaborator Contribution | Sending out media flyers and adverts for speaker events to promote trial. Interaction with the wider community of colorectal surgeons in the UK. |
Impact | No specific outputs |
Start Year | 2011 |
Description | US trial coordination |
Organisation | St Jude Children's Hospital |
Department | Department of Surgery |
Country | United States |
Sector | Hospitals |
PI Contribution | Overall responsibility for development of trial protocol and trial management systems for the conduct and coordination of thestudy; statisitical analysis of trial data. |
Collaborator Contribution | input into protocol development; advice about and facilitation of trial set-up in participating US clinical sites; collection and management of trial data from participating US clinical sites. |
Impact | Publication: PMID 21912876 More generally, the colaboration has greatly facilitated the set-up of the study in US. |
Start Year | 2009 |
Description | American Society of Colon and Rectal Surgeons - Robotic Evidence presentation |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Discussion on the relative merits of robotics application in colorectal surgery - a controversial area and important due to the costs of robotics. General consensus that the results of MRC/EME ROLARR trial are going to be influential as the only reliable source of data to inform policy decision in the near future |
Year(s) Of Engagement Activity | 2014 |
Description | Clinical and Robotics Surgical Association - ROLARR Update |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Participants eager to know the final outcome of the ROLARR trial. Opportunity to present the timeline for trial dissemination. Share information with US collaborators Timelines for dissemination confirmed with International Collaborators. |
Year(s) Of Engagement Activity | 2014 |
Description | ECCO 34 - European Society of Surgical Oncology - Robotic Technologies |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Discussion of the likely adoption of new technologies into surgical practice General agreement that robotic platforms are an enabling technology |
Year(s) Of Engagement Activity | 2014 |
Description | Edinburgh International Coloproctology Festival - Robotic debate |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Audience discussion and voting on the future role of robotics in colorectal surgery The result of the debate was in favour of robotic colorectal surgery, indicating a clinician preference for continuing robotic application |
Year(s) Of Engagement Activity | 2014 |
Description | International presentation at 6th Asian Robotic Camp for Colorectal Surgeons |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | International conference of colorectal surgeons and industry partners involved in robotic colorectal surgery. Exploring state of the art robotic surgical applications and the evidence base. |
Year(s) Of Engagement Activity | 2017 |
Description | Involvement in academic debate about the conduct of International surgical trials held at RCS England |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presented the ROLARR study as an example of how to conduct international clinical trials of surgical technique, including the problems encountered and how overcome. Influenced learning for others contemplating international trials |
Year(s) Of Engagement Activity | 2016 |
Description | Key note lecture at European Association of Endoscopic Surgery - June 2019 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Invited to give a key note lecture to the European Association of Endoscopic Surgery about the future of robotic surgery based on the outcomes of ROLARR |
Year(s) Of Engagement Activity | 2019 |
Description | Key note lecture on robotic surgery, based on ROLARR findings, at EAES international conference 2019 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Used the results of ROLAR to inform presentation on evidence based robotic surgery for rectal cancer to international audience |
Year(s) Of Engagement Activity | 2019 |
Description | Key note lecture to international robotics conference |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation informing the future of robotic surgery uptake and development |
Year(s) Of Engagement Activity | 2018 |
Description | M62 Coloproctology Course - Fistulae |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Increased awareness of FIAT trial to ACPGBI audience - main target audience Better understanding of how the trail works |
Year(s) Of Engagement Activity | 2014 |
Description | MRC hubs surgical speciality workshop |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Type Of Presentation | Workshop Facilitator |
Geographic Reach | National |
Primary Audience | Health professionals |
Results and Impact | Presentation at the MRC Hubs Surgical Specialty Workshop, June 2013, "Experiences of Implementing and Monitoring Surgical Interventions in RCTs: the ROLARR Trial" n/a |
Year(s) Of Engagement Activity | 2013 |
Description | Methodological presentation (statistics) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Type Of Presentation | Paper Presentation |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Statistical issues in the design of randomised surgical trials: a practical example of the possible solutions. Presentation by Helen Marshall, principal statistician on ROLARR at the 2011 MRC Clinical Trials Methodology Conference in Bristol and the 2011 Society of Clinical Trials Annual Meeting in Vancouver, Canada n/a |
Year(s) Of Engagement Activity | 2011 |
Description | National Cancer Research Institute - Tackling Organisation of Challenging Trials |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | Yes |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Stimulated discussion around the difficulties and solutions in international clinical trials Helped others in their planning of future international clinical trials - with particular reference to surgical trials |
Year(s) Of Engagement Activity | 2014 |
Description | Presentation about ROLARR study design to Society of Perioperative Medicine Clinical Trials Network, November 2017 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | To foster shared learning in clinical trials design for maximum impact |
Year(s) Of Engagement Activity | 2017 |
Description | Presentation of ROLARR trial results to Belgian Society of Surgery, December 2017 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation of the ROLARR results and implivcations for clinical adoption to the Belgian Suregical Society. |
Year(s) Of Engagement Activity | 2017 |
Description | Presentation of first results to European Society of Coloproctology 2015 annual scientific conference |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | First presentation of preliminary results to European audience, including collaborators in ROLARR. Particular interest from media keen to understand the impact on future robotics adoption. Overall, the presentation and results were well received. Research team congratulated on the rigour of the investigation. |
Year(s) Of Engagement Activity | 2015 |
Description | Presentation of initial results from ROLARR to Australian and New Zealand Colorectal Society |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Initial results of ROLARR disseminated to the main colorectal society in the Southern Hemisphere demonstrating little benefit of robotic surgery over laparoscopic surgery in the treatment of rectal cancer |
Year(s) Of Engagement Activity | 2016 |
Description | Presentation of preliminary results at American Society of Colon and Rectal Surgery |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | First presentation of preliminary results to US audience, including collaborators in ROLARR. Particular interest from media keen to understand the impact on future robotics adoption. Several media statements resulted following the presentation having a short term influence on the share price of Intuitive Surgical Inc (manufacturers of the robotic system). Overall, the presentation and results were well received. Research team congratulated on the rigour of the investigation. |
Year(s) Of Engagement Activity | 2015 |
Description | Presentation of preliminary results of ROLARR to European Coloproctology congress |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation of initial results of ROLARR to large European Colorectal Society |
Year(s) Of Engagement Activity | 2016 |
Description | Presentation on ROLARR outcomes to Australian and New Zealand Colorectal Society |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Dissemination of ROLARR outcomes to Australia and New Zealand Colorectal Society |
Year(s) Of Engagement Activity | 2016 |
Description | Presentation on ROLARR outcomes to European Association of Endoscopic Surgery |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation on robotic evidence from ROLARR to international surgical society |
Year(s) Of Engagement Activity | 2016 |
Description | Presentation to European Coloproctology Conference, St Galen, Switzerland 2015 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation of results, including early quality of life date following robotic and laparoscopic rectal cancer resection, to large European congress. Triggered much debate about the role of robotics in colorectal surgery, particularly in relation to the cost effectiveness. |
Year(s) Of Engagement Activity | 2015 |
Description | Press coverage concerning the ROLARR trial, its aims and objectives, and progress to date with reference to global treatment of rectal cancer with robotic systems |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | Articles appeared in following publications: Yorkshire Post (5/4/11) featuring interview with the study's Patient Representative Daily Mail (1/5/11) featuring interview with the study's Patient Representative. Sky News (29/7/11) featuring footage of Principal investigator and co-applicant Enquiries about robotic rectal cancer surgery and its potential benefits |
Year(s) Of Engagement Activity | 2011 |
Description | Robotic Colorectal Surgery - the evidence |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation on the evidence for robotic surgery based on ROLARR study to Clinical Robotic Surgical Association in South Korea |
Year(s) Of Engagement Activity | 2016 |
Description | Update presentation to ECCO, Sept 2013 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Type Of Presentation | Keynote/Invited Speaker |
Geographic Reach | International |
Primary Audience | Health professionals |
Results and Impact | The European Cancer Organisation annual scientific meeting is the largest cancer conference of its kind. As keynote speaker I presented an update of the ROLARR trial to an audience of around 200 participants. This generated much interest, particularly as the trial is recruiting well across Europe and we expect to reach our target recruitment in 2014. Motivation of participating centres to continue recruitment. Generated interest in robotic colorectal surgery from new centres. |
Year(s) Of Engagement Activity | 2013 |
URL | http://eccamsterdam2013.ecco-org.eu |