BOTOX for Ventral Hernia

(PRETOX Trial)

Overseen By William C Bennett, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Disqualifiers: Pregnancy, Neuromuscular disorder, Infection, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a one-time BOTOX® injection into the side abdominal muscles can enhance the success of surgery for large abdominal hernias. Researchers aim for the injection to facilitate closing the abdominal wall without gaps, potentially reducing complications and improving quality of life post-surgery. Participants will receive either BOTOX® or a placebo (a harmless saltwater solution) before their planned hernia surgery. Suitable candidates have a very large ventral hernia and plan to undergo open surgery for repair. The trial will monitor recovery, potential complications, and quality of life over two years. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective BOTOX® treatment benefits more patients, offering a chance to contribute to medical knowledge while potentially improving surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for this treatment?

Studies have shown that using onabotulinumtoxinA (BOTOX®) before surgery for large ventral hernias is generally safe. Research indicates that injecting BOTOX® into the side abdominal muscles does not lead to major complications. Some people have reported temporary muscle weakness and discomfort at the injection site, but these effects are usually mild.

One study found that BOTOX® aided in repairing large hernias without causing significant problems. Another report confirmed that patients did not experience major side effects from the injections. Overall, evidence suggests that BOTOX® is well-tolerated when used before surgery to help close the abdominal wall more effectively. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for ventral hernias, which typically involve surgical repair, onabotulinumtoxinA offers a unique approach by using a neurotoxin to temporarily relax abdominal muscles. This relaxation can make the surgical repair easier and potentially more effective by reducing tension on the repaired area. Researchers are excited about this treatment because it targets the muscle dynamics directly, potentially leading to improved outcomes and reduced recovery times compared to traditional methods.

What evidence suggests that BOTOX might be an effective treatment for ventral hernia?

Research has shown that onabotulinumtoxinA, commonly known as BOTOX®, can aid in closing the abdominal wall during hernia repair. One study found that 91% of patients who received BOTOX® injections achieved successful closure of the muscle and tissue layers, though some required additional techniques. Another study demonstrated that BOTOX® can reduce hernia size, facilitating easier repair. The effects of BOTOX® begin within a few days and can last for several months, providing ample time to assist in surgery. In this trial, participants in the OnabotulinumtoxinA Group will receive BOTOX® injections before hernia surgery, potentially improving the chances of successful repair and recovery. Meanwhile, the Placebo Group will receive saline injections for comparison. ^{2 3 5 6 7}

Who Is on the Research Team?

Lucas R Beffa, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

Adults needing surgery for a large abdominal hernia can join this study. They must be planning an elective open repair with specific surgical techniques and have a hernia defect width of at least 15 cm or meet certain volume ratio criteria.

Inclusion Criteria

My condition meets the specific volume ratio requirement.

I am scheduled for a specific hernia repair surgery through an open method.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Injection

Participants receive image-guided injections of BOTOX® or saline placebo 3-7 weeks before surgery

3-7 weeks

1 visit (in-person)

Surgery

Participants undergo open ventral hernia repair surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery with follow-ups at 30 days, 90 days, 1 year, and 2 years

2 years

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• OnabotulinumtoxinA

Trial Overview The trial tests if injecting 'BOTOX®' (onabotulinumtoxinA) into the side muscles before surgery helps in fully closing the abdomen compared to a saltwater placebo. The success of closure, recovery, complications, and quality-of-life up to 2 years post-surgery are being studied.

How Is the Trial Designed?

Group I: OnabotulinumtoxinA Group Experimental Treatment 3 Interventions

These patients will receive image-guided botulinumtoxin injections as described 21-48 days prior to open ventral hernia repair.

Group II: Placebo Group Placebo Group 3 Interventions

These patients will receive image-guided saline (placebo) injections as described 21-48 days prior to open ventral hernia repair.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Joseph and Florence Mandel Family Foundation

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12102115/

Effectiveness of pre-operative chemical component ... The results of this study suggests that CT-guided chemical component separation with intramuscular injection of OnabotulinumtoxinA may be effective in reducing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05606757

NCT05606757 | A Study to Evaluate Adverse Events and ... The purpose of this study is to evaluate the safety and efficacy of a range of onabotulinumtoxinA (BOTOX) doses to achieve primary fascial closure (PFC) without ...

3. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2024.12650/full

Botulinum Toxin and Progressive Pneumoperitoneum in Loss ... PPP complications were reported in 25.6% of patients, The average reduction of the volume of hernia (VH)/volume of the abdominal cavity (VAC) ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480420308040

The Effects of Preoperative Botulinum Toxin A Injection on ... Contamination was present in 38% of patients. Fascial closure was achieved in 91%, with 57% requiring component separation techniques (CSTs). Subxiphoidal ...

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2021.803023/full

Botulinum Toxin A Facilitated Laparoscopic Repair of ... The effect of BTA is apparent in 2–3 days, with the maximum effect by 2 weeks, and the effect lasts for 6–9 months (18). In 2009, Ibarra-Hurtado et al. (8) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31041556/

Short-term safety of preoperative administration ... Conclusions: We found early preoperative administration of BTA a safe adjunct to large ventral hernia repair, without adverse events related to the ...

7. link.springer.com link.springer.com/article/10.1007/s10029-021-02499-1

A systematic review and meta-analysis of technical aspects ... The injection of botulinum toxin A in the lateral abdominal wall muscles is safe without major procedural complications. The technical aspects, ...