Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias (NCT07349628) | Clinical Trial Compass
CompletedNot Applicable
Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias
Italy32 participantsStarted 2021-01-01
Plain-language summary
Brief Study Description
This prospective observational study evaluates the use of preoperative botulinum toxin A as part of a structured clinical pathway for patients undergoing elective repair of complex midline incisional hernias. Botulinum toxin A is administered before surgery to temporarily relax the abdominal wall muscles, with the aim of improving abdominal wall flexibility and facilitating closure of the hernia without the need for more extensive surgical techniques. The study collects clinical, radiological, and postoperative outcome data to assess surgical feasibility, complications, and early recurrence. The overall goal is to better understand how preoperative muscle relaxation may support safer and more effective abdominal wall reconstruction.
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:
* Age 18 years or older
* Diagnosis of complex midline incisional hernia
* Planned elective surgical repair of the incisional hernia
* Preoperative management including botulinum toxin A administration as part of routine clinical care
* Ability to undergo contrast-enhanced computed tomography imaging
* Ability to provide written informed consent
Exclusion Criteria:
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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
Rate of fascial closure without transversus abdominis release