Our first Paper of the Month for 2018 sees us look at 'Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial'. This is the largest randomized study on robotic vs laparoscopic approach for curative rectal cancer surgery.
Article: JAMA. 2017;318(16):1569-1580. doi:10.1001/jama.2017.7219 October 24/31 - 2017
Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer The ROLARR Randomized Clinical Trial
David Jayne, MD; Alessio Pigazzi, PhD; Helen Marshall, MSc; Julie Croft, BSc; Neil Corrigan, MSc; Joanne Copeland, BSc; Phil Quirke, FMedSci; NickWest, PhD; Tero Rautio, PhD; Niels Thomassen, MD; Henry Tilney, MD; Mark Gudgeon, MS; Paolo Pietro Bianchi, MD; Richard Edlin, PhD; Claire Hulme, PhD; Julia Brown, MSc
What is known on the subject
Previous studies of robotic assistance applied to rectal cancer surgery have been limited to non-randomised comparisons. These studies have demonstrated less blood loss, slightly shorter length of hospital stay, and fewer conversions to open surgery. At the same time, it has been shown that robotic assistance extends operative time and is more expensive than laparoscopic or open approaches. No other major technical or oncological benefits have been found for the robotic approach.
What this study adds
Study design: World wide open randomized trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. All analyses were pre-specified and were conducted on the intention-to-treat population.
Primary endpoint: rate of conversion to open surgery, defined as the use of a laparotomy wound for any part of the mesorectal dissection.
Secondary endpoints: included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Longer-term end points (local recurrence rates, disease-free survival, and overall survival) will be reported at 3 years after the last patient randomization
Patients: Between January 7, 2011, and September 30, 2014, 1276 patients were assessed for eligibility. A total of 471 patients (36.9%) were randomized: 234 to conventional laparoscopic surgery and 237 to robotic-assisted laparoscopic surgery. A total of 466 patients underwent an operation, with 456 (97.9%) undergoing the allocated treatment.
Results: Among 471 randomized patients (mean age, 64.9 years; 320 [67.9%] men. The overall rate of conversion to open laparotomy was 10.1%. Conversion to open was 12.2% in lap group vs 8.1% in robotic group (Adjusted Odds Ratio 95%Ci: 0.61 (0.31-1.21) (p=0.16) The overall CRM+ rate was 5.7%. CRM+ rate was 6.3% in lap group vs 5.1% in robotic group (Adjusted Odds Ratio 95%Ci: 0.78 (0.35-1.76) (p=0.56) Of the other 8 reported pre-specified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups.
Author interpretation: Robotic assistance in patients with rectal cancer suitable for curative resection did not significantly reduce risk of conversion to open surgery when compared to conventional laparoscopic surgery. No other benefits were conferred in the short-term. Subgroup analysis showed potential benefit in males. Participating surgeons were experts in laparoscopic surgery but could be in the final part of the learning curves for robotic surgery.
Comments to the study: This is the largest randomized study on robotic vs laparoscopic approach for curative rectal cancer surgery. The paper is well written, describes in detail patients flow, data collection and provides a balanced discussion of strengths and limitations of the study. A major concern is the fact of the difference in experience of laparoscopic vs robotic surgery in several of the surgeons participating in the trial (although inclusion criteria for surgeons are well defined). No cost benefit analysis has been included (although there is some discussion of this point). Hopefully long-term follow up data will be published, which is very important in oncologic surgery
Implications for colorectal practice
This study did not demonstrate any short term benefit of the robotic-assisted laparoscopic approach to curative rectal cancer surgery. Robotic surgery has come with significant pressure from industry and probably has benefits for treatment of some abdominal and pelvic pathologies. High quality trials (such as ROLARR) are needed to define which pathologies and procedures (e.g. TME, rectopexy, D3 right colectomy) and perhaps which patients might specifically benefit (e.g. males, obese, Low third rectal tumors) from a robotic approach. Long term and cost analysis are also needed.
