title: An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer.
abstract: OBJECTIVE
  There is growing enthusiasm for robotic-assisted laparoscopic operations across many surgical specialities, including colorectal surgery, often not supported by robust clinical or cost-effectiveness data. A proper assessment of this new technology is required, prior to widespread recommendation or implementation.
  
  
  METHODS
  The ROLARR trial is a pan-world, prospective, randomised, controlled, unblinded, superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. It will investigate differences in terms of the rate of conversion to open operation, rate of pathological involvement of circumferential resection margin, 3-year local recurrence, disease-free and overall survival rates and also operative morbidity and mortality, quality of life and cost-effectiveness. The primary outcome measure is the rate of conversion to open operation. For 80% power at the 5% (two-sided) significance level, to identify a relative 50% reduction in open conversion rate (25% to 12.5%), 336 patients will be required. The target recruitment is 400 patients overall to allow loss to follow-up. Patients will be followed up at 30 days and 6 months post-operatively and then annually until 3 years after the last patient has been randomised.
  
  
  CONCLUSIONS
  In many centres, robotic-assisted surgery is being implemented on the basis of theoretical advantages, which have yet to be confirmed in practice. Robotic surgery is an expensive health care provision and merits robust evaluation. The ROLARR trial is a pragmatic trial aiming to provide a comprehensive evaluation of both robotic-assisted and standard laparoscopic surgery for the curative resection of rectal cancer.
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK. f.j.collinson@leeds.ac.uk
authors.forename: Fiona J
authors.initials: FJ
authors.lastname: Collinson
authors.forename: David G
authors.initials: DG
authors.lastname: Jayne
authors.forename: Alessio
authors.initials: A
authors.lastname: Pigazzi
authors.forename: Charles
authors.initials: C
authors.lastname: Tsang
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Barrie
authors.forename: Richard
authors.initials: R
authors.lastname: Edlin
authors.forename: Christopher
authors.initials: C
authors.lastname: Garbett
authors.forename: Pierre
authors.initials: P
authors.lastname: Guillou
authors.forename: Ivana
authors.initials: I
authors.lastname: Holloway
authors.forename: Helen
authors.initials: H
authors.lastname: Howard
authors.forename: Helen
authors.initials: H
authors.lastname: Marshall
authors.forename: Christopher
authors.initials: C
authors.lastname: McCabe
authors.forename: Sue
authors.initials: S
authors.lastname: Pavitt
authors.forename: Phil
authors.initials: P
authors.lastname: Quirke
authors.forename: Carly S
authors.initials: CS
authors.lastname: Rivers
authors.forename: Julia M B
authors.initials: JM
authors.lastname: Brown
mesh_terms: D000328:Adult; D017048:Health Care Costs; D006801:Humans; D007391:International Cooperation; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics / Q000941:ethics / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000191:economics / Q000473:pathology / Q000601:surgery*; D012371:Robotics / Q000191:economics / Q000941:ethics / Q000379:methods*; D016896:Treatment Outcome