Prospective, multicenter, pairwise analysis of robotic-assisted inguinal hernia repair with open and laparoscopic inguinal hernia repair: early results from the Prospective Hernia Study

Purpose: To evaluate and compare peri-operative outcomes through 30 days, including pain and quality of life (QOL) through 3 months across three cohorts of inguinal hernia repair (IHR) patients (robotic-assisted, laparoscopic, and open IHR). Methods: The Prospective Hernia Study is an ongoing, multicenter, comparative, open-label analysis of clinical and patient-reported outcomes from robotic-assisted surgery (RAS) versus open and RAS versus laparoscopic IHR procedures. Patient responses to the Carolinas Comfort Scale (CCS) questionnaire provided QOL outcomes. Results: 504 enrolled patients underwent unilateral or bilateral IHR (RAS, n = 159; open, n = 190; laparoscopic, n = 155) at 17 medical institutions from May 2016 through December 2018. Propensity score matching provided a balanced comparison: RAS versus open (n = 112 each) and RAS versus laparoscopic (n = 80 each). Overall, operative times were significantly different between the RAS and laparoscopic cases (83 vs. 65 min; p < 0.001). Fewer RAS patients required prescription pain medication than either open (49.5% vs. 80.0%; p < 0.001) or laparoscopic patients (45.3% vs. 65.4%; p = 0.013). Median number of prescription pain pills taken differed for RAS vs. open (0.5 vs. 15.5; p = 0.001) and were comparable for RAS vs laparoscopic (7.0 vs. 6.0; p = 0.482) among patients taking prescribed pain medication. Time to return to normal activities differed for RAS vs. open (3 vs. 4 days; p = 0.005) and were comparable for RAS vs. laparoscopic (4 vs. 4 days; p = 0.657). Median CCS scores through 3 months were comparable for the three approaches. Postoperative complication rates for the three groups also were comparable. One laparoscopic case was converted to open. Conclusion: This study demonstrates that IHR can be performed effectively with the robotic-assisted, laparoscopic, or open approaches. There was no difference in the median number of prescription pain medication pills taken between the RAS and laparoscopic groups. A difference was observed in the overall number of patients reporting the need to take prescription pain medication. Comparable operative times were observed for RAS unilateral IHR patients compared to open unilateral IHR patients; however, operative times for RAS overall and bilateral subjects were longer than for open patients. Operative times were longer overall for RAS patients compared to laparoscopic patients; however, there was no difference in conversion and complication rate in the RAS vs. laparoscopic groups or the complication rate in the RAS vs. open group. Time to return to normal activities for RAS IHR patients was comparable to that of laparoscopically repaired patients and significantly sooner compared to open IHR patients.