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.
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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