机器人与开放式腹疝修补术:一项随机对照试验(Robovent试验)

Jonathan Douissard, Jeremy Meyer, Arnaud Dupuis, Andrea Peloso, Julie Mareschal, Christian Toso, Monika Hagen
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引用次数: 1

摘要

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

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.

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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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