PRP in Hiatal Hernia Repair

(PPR-HHR Trial)

Recruiting at 1 trial location

Overseen By Jack Silva, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Surgical procedure

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether using platelet rich plasma (PRP) with mesh in hiatal hernia surgery can improve healing and reduce hernia recurrence. The study involves adults with large hernias and looks at the effects of PRP on healing and recurrence rates. PRP is believed to enhance tissue healing, making the repair stronger. Platelet-rich plasma (PRP) has been underinvestigated for improving hernia repair outcomes, but it may enhance healing and reduce recurrence rates.

Eligibility Criteria

This trial is for adults with large hiatal hernias over 5cm, confirmed by specific imaging tests. It's not suitable for non-English speakers, those who've had previous antireflux surgery, diabetics, recent steroid users or cancer patients, pregnant or breastfeeding women, smokers, and people with low platelet counts or platelet dysfunction.

Inclusion Criteria

Documented hiatal hernia > 5cm on preoperative video esophagram or upper endoscopy

Exclusion Criteria

I have diabetes.

History of platelet dysfunction

I have had surgery to prevent acid reflux.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo hiatal hernia repair with or without PRP application to the mesh

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for hernia recurrence and quality of life improvements

1 year

Visits at 2 weeks, 6 weeks, 6 months, 1 year, and annually thereafter

Treatment Details

Interventions

• Platelet Rich Plasma

Trial Overview The study compares the effectiveness of using Platelet Rich Plasma (PRP) in mesh repair of hiatal hernias against standard mesh repair without PRP. Participants are randomly assigned to either group and followed up for a year to check for hernia recurrence and quality of life related to acid reflux.

Participant Groups

Group I: PRP Experimental Treatment 1 Intervention

Patients in this treatment arm will have PRP injected into the crura of the diaphragm and coating the mesh placed during the hiatal hernia repair.

Group II: No PRP Active Control 1 Intervention

Patients in this arm will undergo an identical surgical procedure, however will not have the addition of PRP injected into the cura of the diaphragm or onto the mesh placed during the hiatal hernia repair.

Platelet Rich Plasma is already approved in United States, European Union for the following indications:

Approved in United States as Platelet Rich Plasma for:

• Facet-mediated lumbar low back pain
• Degenerative joint disease
• Chronic pain

Approved in European Union as Platelet Rich Plasma for:

• Orthopedic conditions
• Musculoskeletal disorders
• Pain management

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+