PPR-HHR: Platelet Rich Plasma in Hiatal Hernia Repair

Sponsor

University of Southern California (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05023174

Collaborator

(none)

150

Enrollment

Locations

Arms

35.4

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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. Our 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. Our 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.

Condition or Disease	Intervention/Treatment	Phase
Hiatal Hernia Large Reflux, Gastroesophageal	Procedure: Hiatal Hernia Repair with Platelet Rich Plasma Procedure: Hiatal Hernia Repair without Platelet Rich Plasma	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized into a treatment arm and a control armPatients will be randomized into a treatment arm and a control arm

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 18, 2021

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PRP

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

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

Active Comparator: No PRP

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

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

Outcome Measures

Primary Outcome Measures

Hernia recurrence on postoperative upper endoscopy or video esophagram [one year]
A hernia of 2 cm or greater on postoperative endoscopy or video esophagram will indicate a recurrence of hiatal hernia

Secondary Outcome Measures

Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score [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.
Proton Pump Inhibitor Use [6 and 12 months]
Reduction in the use of acid-suppressing medications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck Hospital of USC	Los Angeles	California	United States	90033
2	Hoag Hospital	Newport Beach	California	United States	92663

Sponsors and Collaborators

University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John Lipham, Professor, University of Southern California

ClinicalTrials.gov Identifier:

NCT05023174

Other Study ID Numbers:

APP-20-05449

First Posted:

Aug 26, 2021

Last Update Posted:

Oct 28, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by John Lipham, Professor, University of Southern California

Additional relevant MeSH terms:

Gastroesophageal Reflux

Hernia

Hernia, Hiatal

Study Results

No Results Posted as of Oct 28, 2021