An interventional study of Hiatal Hernia Repair with Platelet Rich Plasma and Hiatal Hernia Repair without Platelet Rich Plasma in Hiatal Hernia Large and Reflux, Gastroesophageal, sponsored by University of Southern California. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
Rationale: Gastroesophageal reflux disease (GERD) is a common disease caused by a dysfunctional lower esophageal sphincter and an abnormal esophageal hiatus or hiatal hernia. Approximately 30% of large hiatal hernias will recur after surgery, in part due to weak connective tissue at the hiatus. Platelet rich plasma (PRP) is a promising autologous therapy that may address this shortcoming by substantially enhancing wound healing of the hiatus after repair.
Intervention: PRP will be applied to mesh used in hiatal hernia repair.
Objectives: The objective of this study is to determine the efficacy of PRP in hiatal hernia compared to traditional hernia repair without PRP.
Study population: 150 patients 18 years and older with large (>5cm) paraesophageal hernias.
Study methodology and study arms: a 1:1 allocation ration will be used to randomly assign 75 patients to the experimental arm (PRP with mesh) and 75 patients to the control arm (mesh only).
Study outcomes: The primary outcome will be 1-year postoperative hernia recurrence based on video esophagram and/or upper endoscopy. The secondary outcome will be GERD-Health Related Quality of Life (GERD-HRQL) scores and dysphagia scores at 6 and 12 months.
Follow-up: Patients who undergo fundoplication and hiatal hernia repair with mesh are seen in clinic for follow-up at two weeks, six weeks, six months, one year, and annually thereafter. Video esophagram or upper endoscopy will be performed at 1 year after surgery to assess the primary outcome. The investigators secondary outcome of reduction in GERD-HRQL score will be determined by a difference in the GERD-HRQL score from the preoperative score to the postoperative scores taken at 6 months and 1 year. The investigators secondary outcome of dysphagia will be determined by EAT-10 scores taken at 6 months and 1 year.
Statistics/Analysis: Descriptive statistics will be used. Intention to treat and per protocol analyses will be performed. Frequentist and Bayesian statistical analyses will be used to determine statistically and clinically important outcomes.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 150 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Documented hiatal hernia > 5cm on preoperative video esophagram or upper endoscopy
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Hiatal Hernia Repair with Platelet Rich Plasma
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.
Procedure: Hiatal Hernia Repair without Platelet Rich Plasma
Platelet rich plasma will be injected into the crura of the diaphragm and coating the mesh placed during surgery.
Surgery will be performed without the addition of platelet rich plasma injection
Hernia recurrence on postoperative upper endoscopy or video esophagram
A hernia of 2 cm or greater on postoperative endoscopy or video esophagram will indicate a recurrence of hiatal hernia
Time frame: one year
Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score
GERD quality of life survey responses range from 0-50. A higher score indicated poorer quality of life related to GERD symptoms.
Time frame: 6 and 12 months
Proton Pump Inhibitor Use
Reduction in the use of acid-suppressing medications
Time frame: 6 and 12 months
Started Oct 2021 (actual). Primary completion is estimated for Jul 2027, 68 months after the start.
Of 192 non-industry interventional studies with no phase under Gastroesophageal Reflux, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 68. This study's planned 68 months is above that.
Counting every sponsor, half of 225 studies reached it within 32 months; a quarter within 12 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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