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Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias (Probhe)

2026年6月3日 更新者：Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Prehabilitation With Botulinum Toxin A in Complex Hernia: an Italian Prospective Study on Predictive Scores of Myofascial Release.

In patients with large hernias, chronic retraction of the lateral abdominal wall muscles, and visceral contents that are irreducible within the hernia sac, closure of the midline can be difficult or even impossible. Component separation techniques (CST), in combination with transversus abdominis release (TAR), increase the flexibility of the abdominal wall and facilitate fascial medialization. However, these techniques alter the anatomy of the abdominal wall and are associated with higher risks of wound complications, abdominal wall disruption, and abdominal compartment syndrome (ACS).

Recently, the preoperative injection of Botulinum Toxin A (BTA) has been proposed as an effective form of chemical component separation of the muscles, or more precisely, chemical relaxation. It has been hypothesized that preoperative chemical paralysis of the lateral abdominal wall muscles through BTA increases abdominal wall compliance and facilitates fascial medialization, thereby reducing the need to resort to CST.

However, the current literature still lacks studies evaluating the impact of BTA on predictive scores for myofascial release and the correlation with intraoperative strategies.

研究概览

地位

邀请报名

条件

干预/治疗

研究类型

介入性

注册 (估计的)

44

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
    • Milano
      • Legnano、Milano、意大利、20025
        • Asst Ovest Milanese

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the trial
  • Compliance to follow-up
  • Male and female
  • Written informed consent to preoperative BTA injection and/or surgery
  • Age 18 years old
  • Primary ventral hernia
  • Incisional ventral hernia
  • RDR < 2
  • Defect width 10 cm
  • Loss of domain (LoD) 20%

Exclusion Criteria:

  • Medical or psychiatric conditions that compromises the patient's ability to give informed
  • consent or comply with the study protocol
  • Personal reasons
  • Age < 18 years old
  • RDR ≥ 2
  • Defect width < 10 cm
  • LoD < 20%
  • Pregnancy and breastfeeding
  • Allergy/Intolerance to BTA
  • Neuromuscular disorders and diseases
  • Refuse to give informed consent to preoperative BTA injection and/or surgery

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Posterior Component Separation (PCS) with TAR after BTA injection.
程序：Posterior Component Separation (PCS) with TAR
Posterior Component Separation (PCS) with Transversus Abdominis Release (TAR) is an intraoperative surgical technique performed by the surgeon when a standard retromuscular repair, such as the Rives-Stoppa technique, does not allow for tension-free midline closure. In such cases, additional myofascial release is required, and PCS with TAR is subsequently performed to achieve adequate medial advancement of the abdominal wall components and enable secure, tension-free closure of the midline defect.
实验性的：Rives-Stoppa surgery after BTA injection
程序：Rives-Stoppa
Rives-Stoppa repair is a retromuscular abdominal wall reconstruction technique used when primary fascial closure can be achieved without the need for additional myofascial release. It represents a less invasive approach compared to component separation techniques, such as Posterior Component Separation with Transversus Abdominis Release (PCS with TAR), and is performed in cases where tension-free midline closure is feasible using a standard retromuscular plane dissection.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Improvement in Preoperative Indices Following Botulinum Toxin A Injection
大体时间：Enrollment, 4 weeks after BTA injection, and 12 months after surgery
Changes in preoperative radiological indices following Botulinum Toxin A (BTA) injection will be assessed using abdominal computed tomography (CT) scans. The Rectus-to-Defect Ratio (RDR) will be calculated on pre- and post-injection CT imaging; each 0.5-point increase in RDR is associated with an approximate 20% linear reduction in the need for anterior myofascial release (AMR). The Component Separation Index (CSI) will be determined on axial CT images using the aorta as a fixed reference point and the medial borders of the rectus abdominis muscles. Abdominal cavity volume will be estimated using the ellipsoid volume formula based on craniocaudal, transverse, and anteroposterior diameters measured on CT imaging. Pre- and post-BTA values will be compared to evaluate improvement in abdominal wall compliance and anatomical reconstruction parameters.
Enrollment, 4 weeks after BTA injection, and 12 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection.
大体时间：until the end of the study
Two surgical strategies will be considered based on abdominal wall reconstruction requirements: (A) Posterior Component Separation (PCS) with Transversus Abdominis Release (TAR), and (B) Rives-Stoppa repair, performed when no myofascial release is required. For PCS with TAR procedures, the Posterior Bridging Ratio (PBR) and Anterior Bridging Ratio (ABR) will be assessed as the proportion of the peritoneal sac used as a bridge to achieve tension-free closure of the posterior and anterior fascial layers, respectively. The extent of ABR and PBR will be analyzed in relation to the preoperative effect of Botulinum Toxin A (BTA) injection. In particular, higher percentages (>50%) of PBR and ABR will be considered indicative of poor BTA efficacy, intermediate values (25-50%) of partial efficacy, and low values (0-25%) of good to very good BTA efficacy. The relationship between changes in preoperative indices after BTA administration and the selected surgical approach will be evaluated.
until the end of the study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月17日

初级完成 (估计的)

2029年1月1日

研究完成 (估计的)

2029年2月17日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 57-2024
  • 2025-522451-25-00 (克蒂斯)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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