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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

PPR-HHR Trial Summary

This trial is testing whether using platelet-rich plasma (PRP) to repair a hiatal hernia is more effective than traditional surgery without PRP.

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.Check my eligibility
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.See study design
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.

PPR-HHR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hernia recurrence on postoperative upper endoscopy or video esophagram
Secondary outcome measures
Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score
Proton Pump Inhibitor Use

PPR-HHR 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.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,168 Total Patients Enrolled

Media Library

Platelet Rich Plasma (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05023174 — N/A
Hiatal Hernia Research Study Groups: PRP, No PRP
Hiatal Hernia Clinical Trial 2023: Platelet Rich Plasma Highlights & Side Effects. Trial Name: NCT05023174 — N/A
Platelet Rich Plasma (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05023174 — N/A
Hiatal Hernia Patient Testimony for trial: Trial Name: NCT05023174 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the principal aims of this investigation?

"At the conclusion of this study, which is anticipated to span around one year, researchers will measure hernia recurrence via endoscopic methods or video esophagram. Additional aims include assessing GERD-HRQL by way of survey responses, determining dysphagia scores through analysis and reducing proton pump inhibitor use as an indication of efficacy."

Answered by AI

Are there any openings within this trial for participants?

"Sadly, as per clinicaltrials.gov's records, this particular medical trial is not currently accepting participants. This study was initially posted on October 18th 2021 and the last update occurred 15 days ago in October 2022. However, there are still 223 other studies that invite patients to take part right now."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
Hoag Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have pain and if i can help myself and others not suffer, I am willing to try it.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Platelet Rich Plasma in Hiatal Hernia Repair
John Lipham 2021. "Platelet Rich Plasma in Hiatal Hernia Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05023174.
All > Platelet Rich Plasma > Hernia
~21 spots leftby Oct 2024
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