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Botox shots before hernia repair may help surgeons close the gap

NCT ID NCT07220382

Symptom relief Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a one-time Botox injection into the side abdominal muscles, given 3-7 weeks before surgery, helps surgeons fully close large ventral hernias. About 188 adults will be randomly assigned to receive Botox or a placebo, and neither they nor their doctors will know which. The main goal is to see if the abdomen can be closed without leaving a gap, which is linked to fewer problems and better quality of life.

What this could mean

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

Active substance
OnabotulinumtoxinA (Botox)
What this could lead to
If it works, this could make hernia surgery easier and reduce complications, leading to smoother recovery.
What could go wrong
This is a Phase 4 trial with 188 people, so results may not apply to everyone. Risks include temporary muscle weakness and injection site pain.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 188 people

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

Started

Nov 2025

Expected to finish

Dec 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: * Adult (greater than or equal to 18 years of age) * Candidate for elective open repair of ventral hernia * Preoperative imaging demonstrating either: * ventral hernia defect width of at lest 15 cm; AND/OR, * Tanaka volume ratio of at least 25% * Planned elective hernia repair in an open fashion via a midline laparotomy with posterior component separation and transversus abdominis release Exclusion Criteria: * Emergent cases * Pregnancy and/or breastfeeding at time of intramuscular injection * Inability to provide informed consent * Inability to receive either study intervention (i.e. allergy to local anesthetics utilized for intervention administration, allergy and/or contraindication to any botulinum toxin, inability to attend outpatient administration of study intervention, inability to conform to safety check schedule) * Known congenital or acquired neuromuscular disorder * Presence of stoma * Current infection at time of intramuscular injection * Flank hernias s defined by EHS L1-L4 * BMI \> 45 kg/m\^2 * Diaphragmatic hemiparesis or chronic obstructive pulmonary disease (COPD) with chronic oxygen dependence

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Conditions

The condition(s) this trial relates to.

compartment syndrome Hernia Hernia, Abdominal Hernia, Ventral hiatus hernia Incisional Hernia

As listed by the trial registrant

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

Botox injection Hernia Hernia abdominal wall Hernia incisional Hernia incisional ventral Hernia repair with compartment syndrome Hernia surgery

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Cleveland Clinic Main Campus

    RECRUITING

    Cleveland, Ohio, 44195, United States

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