Platelet Rich Plasma in Hiatal Hernia Repair

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Pilot Trial of Platelet Rich Plasma Use in Hiatal Hernia Repair

Conditions
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Hiatal Hernia Large, Reflux, Gastroesophageal

Intervention / Treatment
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* Procedure: Hiatal Hernia Repair with Platelet Rich Plasma
* Procedure: Hiatal Hernia Repair without Platelet Rich Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Documented hiatal hernia > 5cm on preoperative video esophagram or upper endoscopy Exclusion Criteria: 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 Diabetes Active malignancy or treatment for cancer within the last year Pregnancy or active breastfeeding Active smoking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into a treatment arm and a control arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>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<br>* Platelet rich plasma will be injected into the crura of the diaphragm and coating the mesh placed during surgery.<br>|
| Active Comparator: No PRP<br>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<br>* Surgery will be performed without the addition of platelet rich plasma injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 and 12 months | 
| Proton Pump Inhibitor Use | Reduction in the use of acid-suppressing medications | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma, hiatal hernia, fundoplication, mesh