Platelet Rich Plasma in Hiatal Hernia Repair

Reflux, Gastroesophageal Clinical Trial

— PPR-HHR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05023174
• Other study ID #: APP-20-05449
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Hernia
• Hernia, Hiatal
• Hiatal Hernia Large
• Reflux, Gastroesophageal

Intervention

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.
• Hiatal Hernia Repair without Platelet Rich Plasma
Surgery will be performed without the addition of platelet rich plasma injection

Locations

Country	Name	City	State
United States	Keck Hospital of USC	Los Angeles	California
United States	Hoag Hospital	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proton Pump Inhibitor Use	Reduction in the use of acid-suppressing medications	6 and 12 months