Robotic versus open ventral hernia repair (ROVHR): a randomized controlled trial protocol.

IF 2.6 2区医学 Q1 SURGERY

Hernia Pub Date : 2025-03-04 DOI:10.1007/s10029-025-03299-7

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":"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.","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":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880124/pdf/","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.

查看原文本刊更多论文

机器人与开放式腹疝修补术（ROVHR）：一项随机对照试验方案。

背景：机器人肌肉后疝修补术已被证明是可行和安全的，但缺乏随机数据来证明显著的临床效益。目前发表的大多数比较研究都是病例系列、回顾性研究、系统评价或大型注册表数据，所有这些都有明显的局限性和偏倚（Bittner等人在Surg Endosc 32:727-734）。https://doi.org/10.1007/s00464-017-5729-0, 2018；Bracale等人在疝25:14 . 71-14 . 80。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 surgery Endosc）。https://doi.org/10.1007/s00464-024-11202-1, 2024；Dewulf等人在BJS公开赛6:zrac057。https://doi.org/10.1093/bjsopen/zrac057, 2022；《中华外科杂志》103:977-991。https://doi.org/10.1016/j.suc.2023.04.007, 2023)。直到最近，Warren等人才进行了第一项随机试验，比较了开放式和机器人肌肉后疝修复与合成补片（Warren等人发表在Surg Endosc）。https://doi.org/10.1007/s00464-024-11202-1, 2024)。目前可获得的数据产生了不一致的结果，为临床决策留下了重大的知识空白。然而，减少机器人肌肉后修补术的住院时间一直是一个被证实的结果，因此，我们假设机器人肌肉后疝修补术可以减少24小时的住院时间，优于开放式肌肉后疝修补术（Carbonell in Ann Surg 267:210-217）。https://doi.org/10.1097/SLA.0000000000002244, 2018)。方法：所有参与研究的机构审查委员会已批准本方案。该试验已在clinicaltrials.gov （NCT: 05472987）上注册。ROVHR试验是一项基于注册表、多中心、双盲随机试验。主要假设是机器人肌肉后疝修补术优于开放式肌肉后疝修补术，因为它至少减少了24小时的住院时间。次要结局包括30天的伤口发病率、再入院率、阿片类药物处方和消耗、术后5天每天获得的NRS-11疼痛评分、promisi -3a疼痛强度调查和患者报告的结局，包括疝相关生活质量（HerQLes）和EuraHS。此外，还将比较直接手术室的费用。讨论：基于现有文献，我们设计了一项随机试验，以确定与开放式肌肉后疝修补术相比，机器人肌肉后疝修补术是否能至少减少24小时的住院时间。本研究将增加高水平的证据，为临床决策提供循证结果。试验注册：NCT05472987。注册于2022年7月20日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Hernia SURGERY-

CiteScore

4.90

自引率

26.10%

发文量

171

审稿时长

4-8 weeks

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.