Actively Recruiting
PREoperative Targeted OnabotulinumtoXina Injection for Abdominal Wall Reconstruction: A Randomized, Double-Blind, Placebo-Controlled Trial
Led by The Cleveland Clinic · Updated on 2025-11-21
188
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
J
Joseph and Florence Mandel Family Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a one-time, image-guided injection of onabotulinumtoxinA (commonly known as BOTOX4) into the side abdominal muscles before surgery can help adults needing open surgery to repair very large abdominal (ventral) hernias. The study compares BOTOX4 injections with placebo (saline) injections to see if this approach improves the ability to fully close the abdominal wall during surgery, which is linked to fewer complications and better quality of life. This is a randomized, double-blind, placebo-controlled trial conducted at a single center. Participants will be randomly assigned to receive either BOTOX4 or a saline placebo injection at six sites on the lateral abdominal wall, 21 to 48 days before their scheduled open ventral hernia repair surgery. Each injection involves a total of 300 units of onabotulinumtoxinA or an equal volume of saline, given under ultrasound or radiographic guidance. All participants will undergo standard hernia repair surgery, with surgeons unaware of the treatment group. Throughout the study, participants will be closely monitored during their hospital stay and followed for up to two years after surgery. Assessments include whether the hernia can be closed fully at the end of surgery, recovery progress, complications, time in intensive care and on ventilators, length of hospital stay, pain levels, and quality of life surveys. Follow-up visits or phone checks occur before surgery and at 30 days, 90 days, 1 year, and 2 years post-surgery to gather detailed outcome data.
CONDITIONS
Brief Title
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (greater than or equal to 18 years of age)
- Candidate for elective open repair of ventral hernia
- Preoperative imaging showing ventral hernia defect width of at least 15 cm and/or Tanaka volume ratio of at least 25%
- Planned elective hernia repair via midline laparotomy with posterior component separation and transversus abdominis release
You will not qualify if you...
- Emergent cases
- Pregnancy or breastfeeding at time of injection
- Inability to provide informed consent
- Allergy or contraindication to botulinum toxin or local anesthetics used
- Inability to attend outpatient injection or follow safety schedule
- Known congenital or acquired neuromuscular disorder
- Presence of stoma
- Current infection at time of injection
- Flank hernias defined by EHS L1-L4
- Body mass index greater than 45 kg/m2
- Diaphragmatic hemiparesis or chronic obstructive pulmonary disease with chronic oxygen dependence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 to 48 days
Participants receive image-guided injections of either BOTOX® or saline (placebo) at six sites on the lateral abdominal wall 21 to 48 days before their hernia repair surgery.
1 injection visit (in-person)
Duration - 1 day
Participants undergo open ventral hernia repair surgery performed in a standard fashion.
1 surgery visit (in-person)
Duration - Up to 2 years
Participants are followed after surgery with clinical assessments and patient-reported outcomes collected up to 2 years to monitor surgical recovery, complications, and quality of life.
Follow-up visits at approximately 30 days, 90 days, 1 year, and 2 years after surgery
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
L
Lucas R Beffa, MD
W
William C Bennett, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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