What side effects are associated with this type of intervention?

Common treatments for hiatal hernia, such as surgical interventions like fundoplication, can have side effects including dysphagia, gas bloat syndrome, and hernia recurrence. Platelet-rich plasma (PRP), which is being studied for its potential to enhance wound healing and tissue regeneration, is generally safe but may cause pain at the injection site, infection, and rare allergic reactions.

What prior FDA approvals exist?

FDA-approved treatments for hiatal hernia primarily include surgical interventions such as laparoscopic Nissen fundoplication, which is designed to reinforce the lower esophageal sphincter and prevent reflux. While PRP is being studied for its potential to enhance wound healing and tissue regeneration in hiatal hernia repair, there are currently no FDA-approved treatments specifically utilizing PRP for this purpose. Traditional treatments focus on mechanical correction and symptom management rather than regenerative therapies.

What other types of research exist?

Promising novel alternatives to PRP for hiatal hernia treatment in 2024 include advanced gastric electrical stimulation techniques, such as nonoperative electrode insertion, miniaturized stimulators, multichannel stimulation protocols, and implantable devices with feedback-controlled mechanisms. These methods aim to enhance tissue regeneration and wound healing effectively.

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PRP in Hiatal Hernia Repair (PPR-HHR Trial)

N/A

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Prior antireflux surgery

Active malignancy or treatment for cancer within the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications from the surgical procedure such as infection or reaction at the site where PRP is applied. Since PRP uses a patient's own blood components, allergic reactions are less likely but can still occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery to prevent acid reflux.

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I have been treated for cancer or had active cancer in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hernia recurrence on postoperative upper endoscopy or video esophagram

Secondary study objectives

Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score

Proton Pump Inhibitor Use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PRPExperimental Treatment1 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 PRPActive Control1 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hiatal Hernia include surgical repair, often involving the use of mesh to reinforce the weakened area, and the application of Platelet Rich Plasma (PRP). Surgical repair aims to correct the anatomical defect by repositioning the stomach and tightening the hiatus. Mesh is used to provide additional support and reduce the risk of recurrence. PRP, an autologous therapy, enhances wound healing and tissue regeneration by releasing growth factors that promote cell proliferation and tissue repair. This is particularly important for Hiatal Hernia patients as it can improve the durability of the repair and reduce the likelihood of hernia recurrence, leading to better long-term outcomes.