Clinical Trial

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

Study acronym: Probhe
Enrolling by Invitation Phase 2
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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.
Trial Details
NCT Number NCT07628205
Lead Sponsor Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
Conditions Hernia
Enrollment 44 participants
Start Date 2026-02-17
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-02-17 (estimated)
Updated on ClinicalTrials.gov 2026-06-04