Hiatal Hernia LargePPR-HHRNCT05023174
Platelet Rich Plasma in Hiatal Hernia Repair
A study testing Hiatal Hernia Repair with Platelet Rich Plasma and Hiatal Hernia Repair without Platelet Rich Plasma in people with Hiatal Hernia Large and Reflux, Gastroesophageal, run by University of Southern California at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiatal Hernia Large, Reflux, Gastroesophageal
- What is being tested?
- Hiatal Hernia Repair with Platelet Rich Plasma and Hiatal Hernia Repair without Platelet Rich Plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2021to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented hiatal hernia > 5cm on preoperative video esophagram or upper endoscopy
Who cannot join
- Non-English speaking patients
- Prior antireflux surgery
- Platelet count less than 100,000
- History of platelet dysfunction
- Antiplatelet therapy up to ten days prior to surgery
- Corticosteroids use up to one month before surgery
Show all 10Show fewer
- Diabetes
- Active malignancy or treatment for cancer within the last year
- Pregnancy or active breastfeeding
- Active smoking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Keck Hospital of USC
Los Angeles, California, 90033
Hoag Hospital
Newport Beach, California, 92663
About this study
Official title: A Randomized Pilot Trial of Platelet Rich Plasma Use in Hiatal Hernia Repair
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.
Read more
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.
- Conditions
- Hiatal Hernia Large, Reflux, Gastroesophageal
- Being tested
- Hiatal Hernia Repair with Platelet Rich Plasma, Hiatal Hernia Repair without Platelet Rich Plasma
- Keywords
- platelet rich plasma, hiatal hernia, fundoplication, mesh
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hiatal Hernia Repair with Platelet Rich PlasmaProcedure or surgery
Platelet rich plasma will be injected into the crura of the diaphragm and coating the mesh placed during surgery.
Hiatal Hernia Repair without Platelet Rich PlasmaProcedure or surgery
Surgery will be performed without the addition of platelet rich plasma injection
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | 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. Receives: Procedure: Hiatal Hernia Repair with Platelet Rich Plasma |
| No PRP | Active comparator | 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. Receives: Procedure: Hiatal Hernia Repair without Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (2)
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.
Measured: 6 and 12 months
Proton Pump Inhibitor Use
Reduction in the use of acid-suppressing medications
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start18 Oct 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal Hernia LargeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into a treatment arm and a control arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lipham, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023174
- Sponsor's protocol ID
- APP-20-05449
- Acronym
- PPR-HHR
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial of Platelet Rich Plasma Use in Hiatal Hernia Repair
- ClinicalTrials.gov ID
- NCT05023174
- Acronym / sponsor ID
- PPR-HHR / APP-20-05449
- Conditions
- Hiatal Hernia Large, Reflux, Gastroesophageal
- Keywords
- platelet rich plasma, hiatal hernia, fundoplication, mesh
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into a treatment arm and a control arm
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Procedure: Hiatal Hernia Repair with Platelet Rich PlasmaPatients in this treatment arm will have PRP injected into the crura of the diaphragm and coating the mesh placed during the hiatal hernia repair. |
| No PRP | Active comparator | Procedure: Hiatal Hernia Repair without Platelet Rich PlasmaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented hiatal hernia > 5cm on preoperative video esophagram or upper endoscopy
Key exclusion criteria (10 listed)
- Non-English speaking patients
- Prior antireflux surgery
- Platelet count less than 100,000
- History of platelet dysfunction
- Antiplatelet therapy up to ten days prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hiatal Hernia Repair with Platelet Rich PlasmaPlatelet rich plasma will be injected into the crura of the diaphragm and coating the mesh placed during surgery. | Procedure or surgery | PRP |
| Hiatal Hernia Repair without Platelet Rich PlasmaSurgery will be performed without the addition of platelet rich plasma injection | Procedure or surgery | No PRP |
Primary outcome
Hernia recurrence on postoperative upper endoscopy or video esophagram
Time frame: one year
A hernia of 2 cm or greater on postoperative endoscopy or video esophagram will indicate a recurrence of hiatal hernia
2 secondary outcomes
Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score
Time frame: 6 and 12 months
Proton Pump Inhibitor Use
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hiatal Hernia Repair with Platelet Rich Plasma and Hiatal Hernia Repair without Platelet Rich Plasma in people with Hiatal Hernia Large and Reflux, Gastroesophageal, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence on postoperative upper endoscopy or video esophagram (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.