用于上腹部和脐部疝的补片或网片（MORPHEUS试验）：一项多中心患者盲法随机对照试验的研究方案

Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial.

作者信息

Ponten Jeroen E H, Leenders Bart J M, Charbon Jan A, Lettinga-van de Poll Tanja, Heemskerk Jeroen, Martijnse Ingrid S, Konsten Joop L M, Nienhuijs Simon W

机构信息

Departement of Surgery, Catharina Ziekenhuis Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven, The Netherlands.

出版信息

BMC Surg. 2014 May 22;14:33. doi: 10.1186/1471-2482-14-33.

DOI:10.1186/1471-2482-14-33

PMID:24884770

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4042133/

Abstract

BACKGROUND

Evidence is accumulating that, similar to other ventral hernias, umbilical and epigastric hernias must be mesh repaired. The difficulties involved in mesh placement and in mesh-related complications could be the reason many small abdominal hernias are still primary closed. In laparoscopic repair, a mesh is placed intraperitoneally, while the most common procedure is open surgery is pre-peritoneal mesh placement. A recently developed alternative method is the so-called patch repair, in this approach a mesh can be placed intraperitoneally through open surgery. In theory, such patches are particularly suitable for small hernias due to a reduction in the required dissection. This simple procedure is described in several studies. It is still unclear whether this new approach is associated with an equal risk of recurrence and complications compared with pre-peritoneal meshes. The material of the patch is in direct contact with intra-abdominal organs, it is unknown if this leads to more complications. On the other hand, the smaller dissection in the pre-peritoneal plane may lead to a reduction in wound complications.

METHODS/DESIGN: 346 patients suffering from an umbilical or epigastric hernia will be included in a multi-centre patient-blinded trial, comparing mesh repair with patch repair. Randomisation will take place for the two operation techniques. The two devices investigated are a flat pre-peritoneal mesh and a Proceed Ventral Patch®. Stratification will occur per centre. Post-operative evaluation will take place after 1, 3, 12 and 24 months. The number of complications requiring treatment is the primary endpoint. Secondary endpoints are Verbal Descriptor Scale (VDS) pain score and VDS cosmetic score, operation duration, recurrence and costs. An intention to treat analysis will be performed.

DISCUSSION

This trial is one of the first in its kind, to compare different mesh devices in a randomized controlled setting. The results will help to evaluate mesh repair for epigastric an umbilical hernia, and find a surgical method that minimizes the complication rate.

TRIAL REGISTRATION

Netherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10.

摘要

背景

越来越多的证据表明，与其他腹疝一样，脐疝和上腹疝必须采用补片修补。补片放置的困难以及与补片相关的并发症可能是许多小腹部疝仍采用一期缝合的原因。在腹腔镜修补中，补片放置于腹腔内，而开放手术中最常用的方法是腹膜前补片放置。最近开发的一种替代方法是所谓的贴片修补，在这种方法中，补片可通过开放手术放置于腹腔内。理论上，由于所需的解剖操作减少，这种贴片特别适合小疝。几项研究描述了这种简单的手术。与腹膜前补片相比，这种新方法是否具有相同的复发风险和并发症尚不清楚。贴片材料与腹腔内器官直接接触，尚不清楚这是否会导致更多并发症。另一方面，腹膜前平面较小的解剖操作可能会减少伤口并发症。

方法/设计：346例脐疝或上腹疝患者将纳入一项多中心、患者盲法试验，比较补片修补与贴片修补。对两种手术技术进行随机分组。所研究的两种装置是一种扁平的腹膜前补片和一种Proceed Ventral Patch®。将按中心进行分层。术后1、3、12和24个月进行评估。需要治疗的并发症数量是主要终点。次要终点是语言描述量表（VDS）疼痛评分和VDS美容评分、手术持续时间、复发率和费用。将进行意向性治疗分析。