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NCT05023174 · ClinicalTrials.gov registry record · NA
Platelet Rich Plasma in Hiatal Hernia Repair
A NA study of Hiatal Hernia Large and Reflux, Gastroesophageal, sponsored by University of Southern California.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT05023174 is a NA study of Hiatal Hernia Large and Reflux, Gastroesophageal that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 150 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT05023174, a NA study of Hiatal Hernia Large and Reflux, Gastroesophageal, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study 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 stati
Conditions Studied
Interventions
- PROCEDURE Hiatal Hernia Repair with Platelet Rich Plasma
- PROCEDURE Hiatal Hernia Repair without Platelet Rich Plasma
Study Locations (2)
California
- Keck Hospital of USC - Los Angeles
- Hoag Hospital - Newport Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2027-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05023174
The ClinicalTrials.gov registry entry for NCT05023174 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hiatal Hernia Large appearing as the primary indexed condition, and to 2 interventions - of which Hiatal Hernia Repair with Platelet Rich Plasma is the first listed.
NCT05023174 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05023174 about?
NCT05023174 is a clinical study titled "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. Plat...
What is the current status of trial NCT05023174?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-10-18. Estimated completion is 2027-07-01.
What conditions does trial NCT05023174 study?
This clinical trial studies the following conditions: Hiatal Hernia Large, Reflux, Gastroesophageal.
What interventions are being tested in trial NCT05023174?
The interventions under investigation include: Hiatal Hernia Repair with Platelet Rich Plasma (PROCEDURE), Hiatal Hernia Repair without Platelet Rich Plasma (PROCEDURE).
Who is sponsoring clinical trial NCT05023174?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05023174 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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