ROLARR
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
N = 471NCT01736072
- Population
- Patients with rectal adenocarcinoma suitable for curative resection
- Design
- International randomised clinical trial at 29 sites in 10 countries including 40 surgeons (recruitment January 2011 to September 2014; final follow-up June 2015). Patients with rectal adenocarcinoma suitable for curative resection were randomised to robotic-assisted or conventional laparoscopic resection (high or low anterior resection or abdominoperineal resection). Primary outcome conversion to open laparotomy; secondary end points included complications, circumferential resection margin positivity, quality of life, bladder and sexual dysfunction and oncological outcomes. The paper's registry is ISRCTN80500123.
- Primary endpoint
- Conversion to open surgery
- Arms
- Conventional laparoscopic surgery (control, n = 234): Conventional laparoscopic rectal cancer resection
- Robotic-assisted laparoscopic surgery (experimental, n = 237): Robotic-assisted laparoscopic rectal cancer resection
- People
- Jayne D, senior author Brown J
Δ Conversion to open surgery−4.1 pointsΔ Positive circumferential resection margin−1.2 points
Show the numbers
| Endpoint | Analysis | Robotic-assisted laparoscopic surgery | Conventional laparoscopic surgery | Effect |
|---|---|---|---|---|
| Conversion to open surgeryPatients with conversion data (236 robotic-assisted, 230 conventional laparoscopic) of 471 randomisedConversion to open laparotomy (primary outcome) | primaryJayne 2017 | 8.1% | 12.2% | P=0.1619 of 236 robotic-assisted and 28 of 230 conventional laparoscopic patients; overall conversion rate 10.1%. Unadjusted risk difference 4.1% (95% CI -1.4% to 9.6%); adjusted odds ratio 0.61 (95% CI 0.31 to 1.21). The abstract concludes that robotic assistance did not significantly reduce conversion. |
| Positive circumferential resection marginPatients with margin data (235 robotic-assisted, 224 conventional laparoscopic)Circumferential resection margin positivity (secondary end point) | primaryJayne 2017 | 5.1% | 6.3% | P=0.5612 of 235 robotic-assisted and 14 of 224 conventional laparoscopic patients; overall rate 5.7%. Unadjusted risk difference 1.1% (95% CI -3.1% to 5.4%); adjusted odds ratio 0.78 (95% CI 0.35 to 1.76). |
| Endpoint | Analysis | Robotic-assisted laparoscopic surgery | Conventional laparoscopic surgery | Effect |
|---|---|---|---|---|
| Conversion to open surgeryPatients with conversion data (236 robotic-assisted, 230 conventional laparoscopic) of 471 randomisedConversion to open laparotomy (primary outcome) | primaryJayne 2017 | 8.1% | 12.2% | P=0.1619 of 236 robotic-assisted and 28 of 230 conventional laparoscopic patients; overall conversion rate 10.1%. Unadjusted risk difference 4.1% (95% CI -1.4% to 9.6%); adjusted odds ratio 0.61 (95% CI 0.31 to 1.21). The abstract concludes that robotic assistance did not significantly reduce conversion. |
| Positive circumferential resection marginPatients with margin data (235 robotic-assisted, 224 conventional laparoscopic)Circumferential resection margin positivity (secondary end point) | primaryJayne 2017 | 5.1% | 6.3% | P=0.5612 of 235 robotic-assisted and 14 of 224 conventional laparoscopic patients; overall rate 5.7%. Unadjusted risk difference 1.1% (95% CI -3.1% to 5.4%); adjusted odds ratio 0.78 (95% CI 0.35 to 1.76). |
Appears in
Sources
Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, et al. 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. JAMA. 2017;318(16):1569-1580.