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Botox before hernia surgery: a simpler, safer repair?

NCT ID NCT07349628

Symptom relief Sponsor: Azienda Sanitaria Locale Napoli 2 Nord Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether injecting botulinum toxin A (like Botox) into the abdominal muscles before surgery can make it easier to close complex incisional hernias. The idea is that relaxing the muscles allows doctors to repair the hernia without needing more extensive procedures. The study followed 32 adults undergoing planned hernia repair and measured how often the hernia could be closed with a simpler technique, as well as complication rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin A
What this could lead to
If successful, this approach could make complex hernia repairs safer and less invasive, reducing the need for more extensive surgery.
What could go wrong
This is a small, observational study with only 32 participants, so results may not apply to everyone. Botulinum toxin A can cause temporary muscle weakness or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

32 people

The number who actually took part.

Started

Jan 2021

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

* Emergency hernia repair * Lateral or non-midline incisional hernia * Presence of true loss of domain requiring alternative surgical strategies * Previous allergic reaction or contraindication to botulinum toxin A * Neuromuscular disorders contraindicating botulinum toxin administration * Pregnancy or breastfeeding * Inability to comply with planned follow-up schedule

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Incisional Hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Incisional hernia

Contacts and locations

Locations

  • Aslnapoli2Nord

    Naples, Naples, 80131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.