Alvaro C Carvalho, Kimberly P Woo, Ryan C Ellis, Chao Tu, Benjamin T Miller, Ajita S Prabhu, Michael J Rosen, David M Krpata, Clayton C Petro, Lucas R Beffa
{"title":"Robotic versus open ventral hernia repair (ROVHR): a randomized controlled trial protocol.","authors":"Alvaro C Carvalho, Kimberly P Woo, Ryan C Ellis, Chao Tu, Benjamin T Miller, Ajita S Prabhu, Michael J Rosen, David M Krpata, Clayton C Petro, Lucas R Beffa","doi":"10.1007/s10029-025-03299-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Robotic retromuscular hernia repair has proven to be feasible and safe but lacks randomized data to demonstrate significant clinical benefit. The majority of current comparative studies published have been case series, retrospective studies, systematic reviews, or large registry data, all of which have significant limitations and bias (Bittner et al. in Surg Endosc 32:727-734. https://doi.org/10.1007/s00464-017-5729-0 , 2018; Bracale et al in Hernia 25:1471-1480. https://doi.org/10.1007/s10029-021-02487-5 , 2021; Carbonell in Ann Surg 267:210-217. https://doi.org/10.1097/SLA.0000000000002244 , 2018; (Warren et al. in Surg Endosc. https://doi.org/10.1007/s00464-024-11202-1 , 2024; Dewulf et al in BJS Open 6:zrac057. https://doi.org/10.1093/bjsopen/zrac057 , 2022; Maskal and Beffa in Surg Clin N Am 103:977-991. https://doi.org/10.1016/j.suc.2023.04.007 , 2023). It was only recently that the first randomized trial was conducted by Warren et al. comparing open and robotic retromuscular hernia repairs with synthetic mesh (Warren et al. in Surg Endosc. https://doi.org/10.1007/s00464-024-11202-1 , 2024). The data currently available has yielded inconsistent outcomes leaving significant knowledge gaps for clinical decision making. Reduced length of stay for robotic retromuscular repairs has been a consistently proven outcome, however, and therefore, we hypothesized that robotic retromuscular hernia repairs would be superior to open retromuscular hernia repair by reducing length of stay in the hospital by 24 h (Carbonell in Ann Surg 267:210-217. https://doi.org/10.1097/SLA.0000000000002244 , 2018).</p><p><strong>Methods: </strong>The Institutional Review Board at all participating sites has approved this protocol. This trial has been registered on clinicaltrials.gov (NCT: 05472987). The ROVHR trial is a registry-based, multicenter, double-blinded randomized trial. The primary hypothesis is robotic retromuscular hernia repairs is superior to open retromuscular hernia repairs by reducing length of stay by at least 24 h. Secondary outcomes include 30-day wound morbidity, readmissions, opioids prescribed and consumed, NRS-11 pain scores obtained daily for the 5 first days after surgery, PROMIS-3a Pain Intensity survey, and patient reported outcomes including Hernia-Related Quality of Life (HerQLes), and EuraHS. Additionally, direct operating room costs will be compared.</p><p><strong>Discussion: </strong>Based existing literature, we designed a randomized trial with a primary endpoint to determine if robotic retromuscular hernia repairs reduce length of in hospital stay by at least 24 h compared to open retromuscular hernia repairs. This study will add high-level of evidence providing evidence-based outcomes for clinical decision making.</p><p><strong>Trial registration: </strong>NCT05472987. Registered on July 20, 2022.</p>","PeriodicalId":13168,"journal":{"name":"Hernia","volume":"29 1","pages":"109"},"PeriodicalIF":2.6000,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hernia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10029-025-03299-7","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Robotic retromuscular hernia repair has proven to be feasible and safe but lacks randomized data to demonstrate significant clinical benefit. The majority of current comparative studies published have been case series, retrospective studies, systematic reviews, or large registry data, all of which have significant limitations and bias (Bittner et al. in Surg Endosc 32:727-734. https://doi.org/10.1007/s00464-017-5729-0 , 2018; Bracale et al in Hernia 25:1471-1480. https://doi.org/10.1007/s10029-021-02487-5 , 2021; Carbonell in Ann Surg 267:210-217. https://doi.org/10.1097/SLA.0000000000002244 , 2018; (Warren et al. in Surg Endosc. https://doi.org/10.1007/s00464-024-11202-1 , 2024; Dewulf et al in BJS Open 6:zrac057. https://doi.org/10.1093/bjsopen/zrac057 , 2022; Maskal and Beffa in Surg Clin N Am 103:977-991. https://doi.org/10.1016/j.suc.2023.04.007 , 2023). It was only recently that the first randomized trial was conducted by Warren et al. comparing open and robotic retromuscular hernia repairs with synthetic mesh (Warren et al. in Surg Endosc. https://doi.org/10.1007/s00464-024-11202-1 , 2024). The data currently available has yielded inconsistent outcomes leaving significant knowledge gaps for clinical decision making. Reduced length of stay for robotic retromuscular repairs has been a consistently proven outcome, however, and therefore, we hypothesized that robotic retromuscular hernia repairs would be superior to open retromuscular hernia repair by reducing length of stay in the hospital by 24 h (Carbonell in Ann Surg 267:210-217. https://doi.org/10.1097/SLA.0000000000002244 , 2018).
Methods: The Institutional Review Board at all participating sites has approved this protocol. This trial has been registered on clinicaltrials.gov (NCT: 05472987). The ROVHR trial is a registry-based, multicenter, double-blinded randomized trial. The primary hypothesis is robotic retromuscular hernia repairs is superior to open retromuscular hernia repairs by reducing length of stay by at least 24 h. Secondary outcomes include 30-day wound morbidity, readmissions, opioids prescribed and consumed, NRS-11 pain scores obtained daily for the 5 first days after surgery, PROMIS-3a Pain Intensity survey, and patient reported outcomes including Hernia-Related Quality of Life (HerQLes), and EuraHS. Additionally, direct operating room costs will be compared.
Discussion: Based existing literature, we designed a randomized trial with a primary endpoint to determine if robotic retromuscular hernia repairs reduce length of in hospital stay by at least 24 h compared to open retromuscular hernia repairs. This study will add high-level of evidence providing evidence-based outcomes for clinical decision making.
Trial registration: NCT05472987. Registered on July 20, 2022.
期刊介绍：
Hernia was founded in 1997 by Jean P. Chevrel with the purpose of promoting clinical studies and basic research as they apply to groin hernias and the abdominal wall . Since that time, a true revolution in the field of hernia studies has transformed the field from a ”simple” disease to one that is very specialized. While the majority of surgeries for primary inguinal and abdominal wall hernia are performed in hospitals worldwide, complex situations such as multi recurrences, complications, abdominal wall reconstructions and others are being studied and treated in specialist centers. As a result, major institutions and societies are creating specific parameters and criteria to better address the complexities of hernia surgery.
Hernia is a journal written by surgeons who have made abdominal wall surgery their specific field of interest, but we will consider publishing content from any surgeon who wishes to improve the science of this field. The Journal aims to ensure that hernia surgery is safer and easier for surgeons as well as patients, and provides a forum to all surgeons in the exchange of new ideas, results, and important research that is the basis of professional activity.
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