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Botox injection before hernia surgery may reduce need for risky muscle cuts

NCT ID NCT07628205

Disease control Sponsor: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Italian study tests whether injecting Botulinum Toxin A (Botox) into the abdominal muscles weeks before surgery can relax them, making it easier to close large hernias. Researchers will measure changes in CT scans and see if this reduces the need for complex surgical techniques. The trial enrolls 44 adults with large ventral or incisional hernias.

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 (Botox)
What this could lead to
If it works, this could make complex hernia surgery simpler and safer by relaxing the abdominal muscles beforehand.
What could go wrong
This is a small, early-phase study with only 44 participants, so results may not apply to everyone. Botox injections carry risks like muscle weakness or allergic reaction.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

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.

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: * 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

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Conditions

The condition(s) this trial relates to.

Hernia hiatus hernia

As listed by the trial registrant

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

Hernia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asst Ovest Milanese

    Legnano, Milano, 20025, Italy

More trials for these conditions

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