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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Improvement in Preoperative Indices Following Botulinum Toxin A Injection [Срок оценки: Enrollment, 4 weeks after BTA injection, and 12 months after surgery]

Вторичные конечные точки (1)

• Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection. [Срок оценки: until the end of the study]

Критерии участия

Критерии включения

• 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%

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Asst Ovest Milanese — Legnano

Идентификаторы

NCT: NCT07628205 · 57-2024 · 2025-522451-25-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗