Hiatal Hernia Large, Reflux, Gastroesophageal
Conditions
Keywords
platelet rich plasma, hiatal hernia, fundoplication, mesh
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.
Interventions
PROCEDUREHiatal 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.
PROCEDUREHiatal Hernia Repair without Platelet Rich Plasma
Surgery will be performed without the addition of platelet rich plasma injection
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Patients will be randomized into a treatment arm and a control arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed