PRP in Hiatal Hernia Repair

(PPR-HHR Trial)

Enrolling by invitation at 1 trial location

Overseen By Jack Silva, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Antiplatelets, Corticosteroids

Disqualifiers: Non-English, Prior antireflux, Diabetes, Cancer, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding platelet-rich plasma (PRP) to hiatal hernia repair surgery can prevent the hernia from recurring. Hiatal hernias often lead to gastroesophageal reflux disease (GERD), and about 30% of large hernias return after surgery. The study compares two groups: one receives PRP during surgery, and the other does not. Participants with a large hiatal hernia (over 5cm) and frequent reflux are sought for this trial.

As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial requires that you stop taking antiplatelet therapy at least ten days before surgery and corticosteroids one month before surgery. Other medications are not specified, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Platelet Rich Plasma (PRP) in hernia repairs is generally safe. In one study, PRP was used during hernia surgeries in 12 patients, and none experienced serious or unexpected problems from the treatment.

Another study found that applying PRP to the mesh used in hernia repairs is not only safe but might also improve the surgery's results. The mesh supports weakened tissues, and PRP seems to enhance its effectiveness by boosting healing.

Overall, current evidence suggests that PRP is well-tolerated in hernia repairs, with no major safety concerns reported in the available studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Platelet Rich Plasma (PRP) in hiatal hernia repair because it introduces a new way to enhance healing. Unlike the standard surgical repair, which mainly relies on stitching and mesh placement, PRP leverages the body's own healing factors by injecting a concentrated amount of platelets into the diaphragm and onto the mesh. This method aims to speed up recovery and improve tissue integration, potentially reducing complications and recurrence rates. The promise of PRP lies in its ability to naturally boost the body's repair processes, offering a more holistic approach to treatment.

What evidence suggests that PRP is effective for hiatal hernia repair?

Research has shown that platelet-rich plasma (PRP) can safely and effectively aid in wound healing. It is already used successfully to treat chronic wounds, enhancing tissue repair. One study found that PRP was effective in large paraesophageal hernia repairs without major side effects. In this trial, one group of participants will receive PRP injected into the crura of the diaphragm and applied to the mesh during hiatal hernia repair. The aim is for PRP to strengthen the tissue around a repaired hiatal hernia, potentially reducing the risk of recurrence. This is promising because many hernias return after surgery due to weak tissue. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352183/

Platelet-Rich Therapies in Hernia Repair - PubMed Central PRP has been proven to be a safe and effective treatment option for the management of chronic wounds [35]. However, despite the numerous ...

2. researchgate.net researchgate.net/publication/367320655_Platelet-Rich_Plasma_in_Large_Paraesophageal_Hernia_Repair_A_Feasibility_Study

Platelet-Rich Plasma in Large Paraesophageal Hernia ... Results PRP was successfully administered during PEH repair in 12 consecutive patients. There were no significant adverse events. The methods ...

3. ctv.veeva.com ctv.veeva.com/study/platelet-rich-plasma-in-hiatal-hernia-repair

Platelet Rich Plasma in Hiatal Hernia Repair Study outcomes: The primary outcome will be 1-year postoperative hernia recurrence based on video esophagram and/or upper endoscopy. The ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34545035/

Repair of Large Hiatal Hernias With the Use of Mesh and ... Our study has shown that the collagen content is reduced in patients with large HH; thus, it is advisable to use mesh for HH repair in such patients.

5. withpower.com withpower.com/trial/phase-hernia-hiatal-8-2021-6cca5

PRP in Hiatal Hernia Repair (PPR-HHR Trial) This trial is testing whether using platelet rich plasma (PRP) with mesh in hiatal hernia surgery can improve healing and reduce hernia recurrence.

6. researchgate.net researchgate.net/publication/382641045_Platelet-Rich_Therapies_in_Hernia_Repair_A_Comprehensive_Review_of_the_Impact_of_Platelet_Concentrates_on_Mesh_Integration_in_Hernia_Management

(PDF) Platelet-Rich Therapies in Hernia Repair The use of PRP-coated meshes for hernia repair has been reported in the literature, but a review of technical aspects and outcomes is missing.