Hiatal Hernia Repair with Platelet Rich Plasma for Gastroesophageal Reflux

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Keck Hospital of USC, Los Angeles, CA
Gastroesophageal Reflux+3 More
Hiatal Hernia Repair with Platelet Rich Plasma - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether PRP can reduce the risk of hernia recurrence after hiatal hernia repair.

See full description

Eligible Conditions

  • Gastroesophageal Reflux
  • Hiatal Hernia Large

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Hiatal Hernia Repair with Platelet Rich Plasma will improve 2 primary outcomes and 5 secondary outcomes in patients with Gastroesophageal Reflux. Measurement will happen over the course of 6 and 12 months.

6 and 12 months
Dysphagia
GERD-HRQL
Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score
PPI Use
Proton Pump Inhibitor Use
one year
Hernia recurrence
Hernia recurrence on postoperative upper endoscopy or video esophagram

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

No PRP
1 of 2
PRP
1 of 2
Active Control
Experimental Treatment

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Hiatal Hernia Repair With Platelet Rich Plasma is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PRP
Procedure
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.
No PRP
Procedure
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one year for reporting.

Who is running the study

Principal Investigator
J. L.
Prof. John Lipham, Professor
University of Southern California

Closest Location

Keck Hospital of USC - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
- Documented hiatal hernia > 5cm on preoperative video esophagram or upper endoscopy

Patient Q&A Section

What are common treatments for hernia, hiatal?

"These are frequently done but there is no evidence to support any specific approach. The American Urological Association (AUA) has published guidelines for both laparoscopic and open repair.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of hernia, hiatal?

"This investigation has shown that there are significant differences in the presentation of women with a diagnosis of hiatal hernia compared to a diagnosis of gastro-oesophageal reflux disease when presenting to a physician with clinical symptoms. In addition, a significant percentage of this hiatal hernia group had a high-grade dysplasia during the same initial consultation." - Anonymous Online Contributor

Unverified Answer

What is hernia, hiatal?

"The hiatal hernia is the herniation of part of the stomach into the diaphragmatic pouch that leads to discomfort during full or partial stomach emptying. The hiatal hernia may lead to a heartburn, difficulty swallowing, heartburn following exertion, chronic abdominal pain, and nausea.\n" - Anonymous Online Contributor

Unverified Answer

How many people get hernia, hiatal a year in the United States?

"Approximately 7.6 million Americans are affected with hernia, and over 6.7 million Americans will be affected within two years. Over 70% of these cases will go unreported. As hernias are a common problem and the treatments are difficult, there is a great importance to educate the public about hernias." - Anonymous Online Contributor

Unverified Answer

What causes hernia, hiatal?

"The development of hernia and hiatal hernias may be influenced by a number of mechanisms, including genetic susceptibility, environmental factors, and anatomical or hormonal abnormalities. No one theory has been found to be completely successful in explaining all hernias." - Anonymous Online Contributor

Unverified Answer

Can hernia, hiatal be cured?

"In the present series, hernia surgery did not guarantee a cure of pelvic organ adhesions, even with the use of laparoscopic surgery. As the number of adhesions at the time of hernia surgery increased, the risk of recurrence was also increased." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hernia, hiatal?

"The latest research has shown that most research evaluating treatment for hiatal hernias is old and needs to be repeated and that the results are not uniformly available." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving hiatal hernia repair with platelet rich plasma?

"There is substantial support for the use of PRP in this cohort of patients; and this treatment had no adverse clinical outcomes. The use of PRP as an adjunct to conventional repair appears to result in no added harm. There appears to be significant benefit associated with PRP in the symptomatic relief of some patients." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hernia, hiatal?

"Clinical trials for hernia, hiatal are feasible. Many of the trials have not yet been performed in Western countries and there are some discrepancies in their methodology. But it seems that, at present, a large portion of hernia, hiatal diseases receive the same type of treatment as GI diseases. Therefore, clinical trial indications should be reconsidered cautiously and carefully." - Anonymous Online Contributor

Unverified Answer

Does hiatal hernia repair with platelet rich plasma improve quality of life for those with hernia, hiatal?

"After hiatal hernia repair with platelet rich plasma, patients' quality of life improves in their respective dimensions. They report improved overall quality of life, and lower levels of pain and distress. In addition, they enjoy the perceived improvements associated with this procedure. We also found that this procedure offers low cost, minimal recovery time, satisfaction, and the possibility of a long-term effect for patients with hiatal hernia." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hernia, hiatal?

"In the last three decades, hernia surgery could get a lot improved due to modern advancements in the field of surgical techniques. There are still some situations, however, where there are still unsolved hernia problems. [Surgical mesh (polyethylenes, polypropylenes and elastomers); biologics (proteins); bioengineered mesh (degraded tissues and collagen); synthetic mesh (polystyrene, polyurethanes, polydioxanones) and others." - Anonymous Online Contributor

Unverified Answer

What is hiatal hernia repair with platelet rich plasma?

"The use of autologous blood platelet-rich plasma seems to be as effective as the injection of injectable and autologous fibrin glue in the repair of H. hernia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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