Robotic versus Laparoscopic Ventral Hernia Repair: A Multicenter, Blinded Randomized Controlled Trial

Background: There has been a recent widespread performance of and publication on robotic ventral hernia repair (RVHR). A national database study demonstrated decreased hospital stay with RVHR compared to laparoscopic repair (LVHR). However, no randomized controlled trial (RCT) has evaluated RVHR. We hypothesized that RVHR compared to LVHR is associated with fewer days in the hospital 90-days post-operative. Methods: In this blinded, multicenter RCT, patients scheduled to undergo elective VHR were randomized to RVHR or LVHR and stratified by surgeon. Primary outcome was days in hospital within 90-days post-operative. Secondary outcomes included emergency room visits, operating room time, wound complications, hernia recurrence, reoperation, quality of life (QOL), and costs from the healthcare system perspective. Outcomes were assessed through frequentist (negative binomial, generalized linear or logistic regression) and Bayesian analyses. Findings: A total of 124 patients were enrolled and randomized: 65 underwent RVHR and 59 LVHR. Patients from both groups were similar at baseline. Ninetyday follow-up was completed in 123 patients (99·2%). There was no difference in days in hospital between the two groups (median 0 vs 0 days; RR=0·90 [95%CI=0·37-2·19]; p=0·822). On secondary outcomes, no differences were noted in emergency room visits, wound complications, hernia recurrence, or reoperation. However, RVHR had longer operative duration (141 vs 77 minutes; coefficient=62·89 [95%CI=45·75-80·01]; p=<0·001) and increased healthcare costs ($15,864 vs $12,954; RR=1·21 [95%CI=1·07-1·38]; p=0·004). In addition, RVHR had clinically important differences in enterotomies (3% vs 0%; p=0·996) and less median improvement in early post-operative QOL (3 vs 15, p=0·060). On Bayesian analysis, RVHR had a 78% probability of being associated with more enterotomies while LVHR had a 66% probability of having greater improvement in early post-operative QOL. Interpretation: Both RVHR and LVHR have similar 90-day postoperative hospital stays. However, RVHR increased operative duration, healthcare costs, and risk of enterotomy while LVHR had a greater improvement of patient QOL. Trial Registration: clinicaltrials.gov (NCT03490266). Funding Statement: This study was supported by an investigator initiated grant from Intuitive Surgical. Declaration of Interests: Dr. Shah receives consulting fees from C-SATS and educational honoraria from Gore. Also discloses past research grant support from Neosurgical and Medigus. Dr. Wilson receives consulting fees from Conmed and Livsmed. Also discloses being on advisory board of ColubrisMX. All other authors declare no conflicts of interest. Ethics Approval Statement: A multicenter, multi-blinded RCT was performed after obtaining institutional review board (IRB) approval. Participating centers included Memorial Hermann Hospital System and Lyndon Baines Johnson General Hospital. The Consolidated Standards of Reporting Trials (CONSORT) guidelines were followed. Patients who voluntarily agreed to participate in the study signed a surgical informed consent and a separate research consent prior to enrollment.