ROLARR


Rolarr Trial Logo

Robotic versus Laparoscopic Resection for Rectal cancer

Background/Rationale

The safety and efficacy of robotic-assisted laparoscopic surgery have been established for certain operations, most notably radical prostatectomy. Pelvic surgery, including rectal cancer surgery, lends itself to robotic-assistance. However, the experience with robotic-assisted rectal cancer surgery is limited to a few small personal series and one randomised clinical trial. Although this data suggests it is feasible, it has not established a benefit over standard laparoscopic surgery in terms of technical, functional or oncological outcomes. The primary aim of any curative cancer surgery is complete oncological resection of the tumour with minimal morbidity. It is therefore of utmost importance that prior to the widespread use of robotics in rectal cancer surgery, it is subjected to rigorous evaluation. The use of this new technology incurs additional financial burdens on already overstretched health care resources and it is therefore essential to assess the health economics and cost-effectiveness in comparison to alternative treatments. As this trial is unlikely to be repeated, 3-year outcomes and cost effectiveness will be included within this trial. Specifically, it is aimed to provide information on the ability of the robotic system to facilitate laparoscopic rectal cancer resection, its impact on oncological outcomes (short-term and long-term), its effect on functional outcomes and QoL, and its cost-effectiveness in terms of future healthcare decision-making. Currently, and for the foreseeable future, there is only one surgical robotic system, the da Vinci™ robot. To avoid any criticism of commercial bias, it is imperative that an evaluation of this robotic technology is performed independently of the manufacturer.

Since this is a new technology, it is essential that a proper evaluation is performed and disseminated prior to its widespread implementation. A timely assessment is imperative and for this reason there is no plan to perform a prior pilot study, which would inevitably delay evaluation by proper scientific methods. The feasibility of robotic-assisted rectal cancer surgery has already been established and preliminary data upon which to base sample size calculations are available. The time is right for a formal randomised controlled trial to provide a definitive answer to the proposed research question.

Aims/Objectives

The purpose of the trial is to perform a rigorous evaluation of robotic-assisted rectal cancer surgery by means of a randomised, controlled trial. The chosen comparator is standard laparoscopic rectal cancer resection, which is essentially the same procedure but without the use of the robotic device. The two operative interventions will be evaluated for short- and longer-term outcomes. The key short-term outcomes will include assessment of technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation, and clear pathological resection margins as an indicator of surgical accuracy and improved oncological outcome. In addition, QoL assessment and analysis of cost-effectiveness will be performed to aid evidence-based knowledge to inform NHS and other service providers and decision-makers. These short-term outcomes will be analysed after the last randomised patient has had 6 months of follow-up to provide a timely assessment of the new technology, and made available to the public, clinicians and healthcare providers to inform health-care decision making. Longer-term outcomes will concentrate on oncological aspects of the disease and its surgical treatment with analysis of disease-free and overall survival and local recurrence rates at 3-year follow-up.

Design

The trial is an international, multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. Four-hundred patients will be randomised on an equal basis to either robotic-assisted or standard laparoscopic rectal cancer surgery. The follow-up period finishes 3 years after the final patient is randomised.

Study Organisational Structure

To ensure strong pan-world coordination, the ROLARR trial will be set up on a “Hub-Spoke-Site” model (see Figure), such that individual research sites feed into a regional Spoke CTU, which in turn feeds into the Hub CTU (CTRU) at the University of Leeds.
Research sites will liaise with their regional Spoke CTU for advice and support on trial set-up and operation, and submission of trial data. In turn, Spoke CTUs will be responsible for data chasing and transfer of data to the Hub CTU.

rolarr hub/spoke

Funding

This research grant has been awarded by the Efficacy and Mechanism Evaluation (EME) programme, which is funded by the Medical Research Council and managed by the National Institute for Health Research.

ISRCTN80500123

Trial Status: Recruitment

Chief Investigator: David Jayne, Senior Lecturer in Surgery, University of Leeds

Co-Applicants:
Dr. Alessio Pigazzi (City of Hope, CA USA); Professor Pierre Guillou (LIMM, Leeds UK); Professor Julia Brown (CTRU, Leeds UK); Dr. Sue Pavitt (CTRU, Leeds UK); Mrs Helen Marshall (CTRU, Leeds UK); Dr. Richard Edlin (LIHS, Leeds UK); Professor Charles Tsang (University of Singapore, Singapore); Professor Phil Quirke (LIMM, Leeds UK)

Trial Contacts:

rolarr@leeds.ac.uk

Helen Howard
h.c.howard@leeds.ac.uk
0113 343 2657

Carly Rivers
c.s.rivers@leeds.ac.uk
0113 343 4849