Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial)

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2020-01-01 DOI:10.1016/j.isjp.2020.03.004

Jonathan Douissard, Jeremy Meyer, Arnaud Dupuis, Andrea Peloso, Julie Mareschal, Christian Toso, Monika Hagen

{"title":"Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial)","authors":"Jonathan Douissard, Jeremy Meyer, Arnaud Dupuis, Andrea Peloso, Julie Mareschal, Christian Toso, Monika Hagen","doi":"10.1016/j.isjp.2020.03.004","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>The objective of the present study is to compare the outcomes open PVHR and robotic PVHR.</p></div><div><h3>Methods/Design</h3><p>The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1–5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence.</p></div><div><h3>Discussion</h3><p>Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.</p><p>In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR.</p></div><div><h3>Trial registration</h3><p>The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.</p></div>","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":null,"pages":null},"PeriodicalIF":16.4000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.03.004","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2468357420300115","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}

引用次数: 1

Abstract

Background

The objective of the present study is to compare the outcomes open PVHR and robotic PVHR.

Methods/Design

The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1–5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence.

Discussion

Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.

In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR.

Trial registration

The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.

查看原文本刊更多论文

机器人与开放式腹疝修补术:一项随机对照试验(Robovent试验)

本研究的目的是比较开放式PVHR和机器人PVHR的结果。方法/设计本研究将是一项随机单盲对照试验，通过意向治疗分析，比较机器人PVHR和开放式PVHR在1-5 cm之间的成人选择性PVHR患者中的应用。拒绝参与、不能给予知情同意、有腹腔手术史禁忌机器人手术入路的患者将被排除。干预将包括腹腔镜机器人辅助的经腹腹膜前腹壁或脐脐PVHR，并关闭筋膜缺损和不可吸附的网状物加固。对照组为开放式腹膜前腹壁疝或脐疝修补术，缝合筋膜缺损和不可吸收补片加固。主要观察指标为1个月内伤口相关并发症的发生率。次要结果包括审美满意度、疼痛、止痛药用量、一般并发症、费用、手术时间和早期疝气复发。开放式PVHR可能与更多的伤口相关并发症相关，但具有成本效益、手术时间短和完全腹膜外修复的优点。腹腔镜PVHR具有较低的伤口相关并发症，但需要将补片放置在腹膜内位置，需要高级腹腔镜技术，通常不允许闭合缺损，并可能导致过度疼痛和止痛药消耗。机器人PVHR使用与腹腔镜PVHR相同的腹腔镜通道，但由于机器人系统提供了更大的运动范围，可以关闭缺陷，在腹膜前放置网状物，并且需要更少的技术技能。在目前的随机对照试验中，我们希望证明机器人PVHR比开放式PVHR能带来更好的伤口相关结果。试验注册本随机对照试验已在clinicaltrials.gov注册，注册号为NCT04171921。

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

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.