Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias (Probhe)
3 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
44
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Milano
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Legnano, Milano, Italia, 20025
- Asst Ovest Milanese
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Posterior Component Separation (PCS) with TAR after BTA injection.
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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.
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Experimental: Rives-Stoppa surgery after BTA injection
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Improvement in Preoperative Indices Following Botulinum Toxin A Injection
Periodo de tiempo: Enrollment, 4 weeks after BTA injection, and 12 months after surgery
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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.
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Enrollment, 4 weeks after BTA injection, and 12 months after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection.
Periodo de tiempo: until the end of the study
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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.
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until the end of the study
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de febrero de 2026
Finalización primaria (Estimado)
1 de enero de 2029
Finalización del estudio (Estimado)
17 de febrero de 2029
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 57-2024
- 2025-522451-25-00 (Ctis)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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