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

NCT07628205 | Enrolling By Invitation Phase 2

• 2 other identifiers: 57-20242025-522451-25-00
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

• Improvement in Preoperative Indices Following Botulinum Toxin A Injection

  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

Secondary Outcomes (1)

• Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection.

  until the end of the study

Study Arms (2)

Posterior Component Separation (PCS) with TAR after BTA injection.

EXPERIMENTAL

Procedure: Posterior Component Separation (PCS) with TAR

Rives-Stoppa surgery after BTA injection

EXPERIMENTAL

Procedure: Rives-Stoppa

Interventions

Posterior Component Separation (PCS) with TAR PROCEDURE

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.

Posterior Component Separation (PCS) with TAR after BTA injection.

Rives-Stoppa PROCEDURE

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.

Rives-Stoppa surgery after BTA injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano: lead

Study Sites (1)

Asst Ovest Milanese

Legnano, Milano, 20025, Italy

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 4, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): February 17, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

IT (1)