Clinical trial NCT05023174: Platelet Rich Plasma in Hiatal Hernia Repair
Official title: A Randomized Pilot Trial of Platelet Rich Plasma Use in Hiatal Hernia Repair
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hiatal Hernia Large
Reflux, Gastroesophageal
Keywords: platelet rich plasma
hiatal hernia
fundoplication
mesh
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into a treatment arm and a control arm
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hernia recurrence on postoperative upper endoscopy or video esophagram
timeFrame: one year
Secondary outcomes:
measure: Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score
timeFrame: 6 and 12 months
measure: Proton Pump Inhibitor Use
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
Study officials:
References: