Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias (NCT07628205) | Clinical Trial Compass
By InvitationPhase 2
Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias
Italy44 participantsStarted 2026-02-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in Preoperative Indices Following Botulinum Toxin A Injection
Timeframe: Enrollment, 4 weeks after BTA injection, and 12 months after surgery
Trial details
NCT IDNCT07628205
SponsorAzienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano