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ENROLLING BY INVITATION
NCT07628205
PHASE2

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

Sponsor: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-02-17

Completion Date

2029-02-17

Last Updated

2026-06-04

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

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.

PROCEDURE

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.

Locations (1)

Asst Ovest Milanese

Legnano, Milano, Italy