Platelet Rich Plasma in Hiatal Hernia Repair

NCT05023174 | Active Not Recruiting

• 1 other identifier: APP-20-05449
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Hiatal Hernia Large; Reflux, Gastroesophageal

Keywords

platelet rich plasma; hiatal hernia; fundoplication; mesh

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  6 and 12 months

• Proton Pump Inhibitor Use

  6 and 12 months

Study Arms (2)

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.

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.

Procedure: Hiatal Hernia Repair without Platelet Rich Plasma

Interventions

Hiatal Hernia Repair with Platelet Rich Plasma PROCEDURE

Platelet rich plasma will be injected into the crura of the diaphragm and coating the mesh placed during surgery.

PRP

Hiatal Hernia Repair without Platelet Rich Plasma PROCEDURE

Surgery will be performed without the addition of platelet rich plasma injection

No PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Documented hiatal hernia \> 5cm on preoperative video esophagram or upper endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Hoag Hospital

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research personnel will be aware of whether the patient is in the treatment or control arm. The patient will be blinded from this knowledge.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized into a treatment arm and a control arm

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (2)