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A Study of Botulinum Toxin Type A for Preparing the Abdominal Wall Before Surgery in Patients with Large Complex Hernias

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What is this study about?

This study is looking at a condition where people have a large hernia in the abdominal wall, which is an opening or weakness in the muscles of the belly that allows tissue or organs to push through. In this case, the hernia is wide, the muscles on the side of the belly have been pulled back for a long time, and the organs inside the hernia cannot be pushed back into place easily. The treatment being studied is Botulinum Toxin Type A, which is a substance that can temporarily relax muscles. This medication will be given as an injection into the muscles of the abdominal wall before surgery to help prepare the area for repair.

The purpose of the study is to see if injecting Botulinum Toxin Type A into the side muscles of the abdominal wall causes changes in certain measurements that doctors use to predict whether additional surgical techniques will be needed to close the hernia. These measurements include the relationship between the width of certain belly muscles and the size of the hernia opening, the distance between specific points in the belly area seen on scans, the width of the hernia itself, the size of the side muscles, and the volume of the abdominal cavity. Doctors want to know if this injection helps improve these measurements before surgery.

During the study, patients will receive injections of Botulinum Toxin Type A into their abdominal wall muscles. Measurements will be taken using imaging scans before and after the injections to see what changes occur. The study will also look at how much of the sac containing the hernia needs to be used during surgery to close the layers of the abdominal wall, both in the back layer and the front layer. This information will help doctors understand if the toxin injections are helpful in preparing patients for hernia repair surgery.

1 Initial assessment and informed consent

Your participation in this clinical trial will begin after you have provided written informed consent for the treatment with botulinum toxin type A and the surgical procedure.

The medical team will confirm that you meet the criteria for participation, including having a hernia (a weakness or opening in the abdominal wall) with a width of at least 10 centimeters.

Initial measurements will be taken using imaging scans to assess the size of your hernia, the position of your abdominal muscles, and the volume of your abdominal cavity.

2 Baseline imaging and measurements

You will undergo a computed tomographic scan (a detailed imaging test that uses X-rays to create pictures of the inside of your body) before receiving any treatment.

The scan will measure several aspects of your condition, including the width of your hernia, the distance between your abdominal muscles, and the overall volume of your abdominal cavity.

Specific measurements will be taken, including the RDR (a calculation comparing the width of your abdominal muscles to the width of the hernia) and the CSI (a measurement that helps predict whether muscle release procedures will be needed during surgery).

The length and width of your lateral muscles (the muscles on the sides of your abdomen) will also be recorded.

3 Botulinum toxin type A injection

You will receive an injection of botulinum toxin type A into the lateral muscles of your abdominal wall.

The medication will be administered as an intramuscular injection (an injection directly into the muscle).

The product used is Botulinum Toxin Type A 500 units, which comes as a powder that will be mixed into a solution before injection.

This injection is intended to temporarily relax your abdominal muscles, which may help prepare your body for the surgical repair of the hernia.

4 Follow-up imaging after injection

After receiving the botulinum toxin injection, you will undergo another computed tomographic scan.

This scan will measure any changes in your condition, including changes in the RDR, CSI, hernia width, lateral muscle measurements, and abdominal cavity volume.

The medical team will compare these measurements to your baseline results to determine how your body has responded to the injection.

These measurements will help assess whether the injection has helped to reduce the size of the hernia, improve muscle positioning, or increase the space within your abdominal cavity.

5 Preparation for surgical repair

Based on the results of your follow-up imaging, the medical team will plan your surgical procedure.

The measurements taken will help determine the surgical approach and whether additional techniques for muscle release will be necessary.

The surgical planning will consider factors such as the percentage of the hernia sac needed to achieve closure of the different layers of your abdominal wall.

6 Surgical procedure

You will undergo surgery to repair your hernia.

During the surgery, the medical team will assess the PBR (the percentage of the hernia sac needed to close the posterior layer of the abdominal wall) and the ABR (the percentage of the hernia sac needed to close the anterior layer of the abdominal wall).

These measurements will be recorded to evaluate the effectiveness of the botulinum toxin injection in preparing your abdominal wall for repair.

7 Post-surgical follow-up

After your surgery, you will attend scheduled follow-up appointments to monitor your recovery.

The medical team will assess the success of the hernia repair and monitor for any complications.

Your continued participation in follow-up visits is an important part of this clinical trial.

Who Can Join the Study?

  • You must be willing and able to give informed consent, which means you agree to participate in the trial after understanding all the information about it
  • The opening in your abdominal wall (called defect width) must be at least 10 centimeters wide
  • You must have a loss of domain of at least 20 percent, which means that a portion of your intestines or other organs have moved into the hernia sac and there is not enough space in your belly to put them back, and you must have concerns about how your belly looks because of the hernia
  • You must be able to attend all follow-up appointments
  • You can be male or female
  • You must provide written consent to receive BTA injection before surgery, which is an injection of botulinum toxin type A into the abdominal wall muscles, and consent to the surgery itself
  • You must be 18 years old or older
  • You may have a primary ventral hernia, which is a hernia that occurs naturally in the front wall of your belly
  • You may have an incisional ventral hernia, which is a hernia that develops at the site of a previous surgical cut in your belly
  • Your RDR (a measurement comparing the size of the hernia to the size of your abdominal cavity) must be less than 2

Who Cannot Join the Study?

  • No exclusion criteria have been specified for this clinical trial in the provided information.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
30.11.2025

Trial locations

Investigated drugs:

Botulinum Toxin A is a medication that is injected into the muscles of the abdominal wall. It works by temporarily relaxing these muscles, which can help prepare patients for complex hernia surgery. In this trial, the medication is being used before surgery to help release and relax the abdominal wall muscles, making it easier for surgeons to repair the hernia.

Investigated diseases:

Incisional Hernia – An incisional hernia occurs when tissue or part of an organ pushes through a weakness in the abdominal wall at the site of a previous surgical incision. This condition develops after abdominal surgery when the surgical wound does not heal properly or the tissues weaken over time. The hernia appears as a bulge under the skin near the old surgical scar. In some cases, the hernia can become large, causing the abdominal wall muscles to retract and remain in a pulled-back position. The contents of the hernia, which may include intestines or other abdominal organs, can become stuck and unable to return to their normal position inside the abdomen. The condition progressively worsens as the opening in the abdominal wall gradually increases in size.

Trial ID:
2025-522451-25-00
Protocol code:
PRoBHe
Trial Phase:
Therapeutic exploratory (Phase II)

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