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Active, Not Recruiting

NCT Number: NCT05023174

Platelet Rich Plasma 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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hiatal Hernia Large Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Reflux, Gastroesophageal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck Hospital of USC, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Hiatal Hernia Repair without Platelet Rich Plasma

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 6 and 12 months

    GERD quality of life survey responses range from 0-50. A higher score indicated poorer quality of life related to GERD symptoms.

  2. Proton Pump Inhibitor Use

    Time frame: 6 and 12 months

    Reduction in the use of acid-suppressing medications

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Acronym: PPR-HHR

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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