PREoperative Targeted OnabotulinumtoXina Injection for Abdominal Wall Reconstruction: A Randomized, Double-Blind, Placebo-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study is for adults who need open surgery to repair a very large abdominal (ventral) hernia. This study tests whether a one-time, image-guided injection of a medicine commonly known as BOTOX® (onabotulinumtoxinA) into the side abdominal muscles 3-7 weeks before surgery helps surgeons close the abdominal wall fully at the end of the operation. Closing the muscle and tissue layers (primary fascial closure) is linked to fewer problems after surgery and better quality of life. Participants will be randomly assigned (like a coin flip) to receive either the BOTOX® medicine or a saltwater (placebo) injection. Neither patients nor the care team will know which one was given. All participants will still have their planned hernia repair in the standard way that we repair patients who are not part of the study. The study will track whether the abdomen can be closed without leaving a gap, and investigators will also look at recovery, complications, time in the ICU or on a ventilator, length of stay, pain, and quality-of-life scores. Most information will be collected during participants' hospital stay, but the investigators will continue to see how participants are doing up to 2 years after surgery. Short phone check-ins will occur before surgery, and after surgery follow-up happens around 30 days, 90 days, 1 year, and 2 years. Possible risks from the injection include temporary muscle weakness, trouble swallowing or breathing, pain or infection at the injection site, and (if CT is used for guidance) a small amount of radiation exposure. Surgery itself carries the usual risks (pain, bleeding, wound problems). Benefits are not guaranteed, but the injection may make closure easier and recovery smoother. About 188 people will take part at Cleveland Clinic.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Contact Information
Primary
Lucas R Beffa, MD
beffal@ccf.org
216-445-5975
Backup
William C Bennett, MD, MS
bennetw2@ccf.org
216-445-9989
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2029-12-15
Participants
Target number of participants: 188
Treatments
Experimental: OnabotulinumtoxinA Group
These patients will receive image-guided botulinumtoxin injections as described 21-48 days prior to open ventral hernia repair.
Placebo_comparator: Placebo Group
These patients will receive image-guided saline (placebo) injections as described 21-48 days prior to open ventral hernia repair.
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic
Collaborators: Joseph and Florence Mandel Family Foundation

This content was sourced from clinicaltrials.gov