Comparison of Outcomes for Single vs Double Pyloromyotomy for Gastroparesis Randomized Controlled Trial
Megadott ok: Study never started
A vizsgálat adatai
- Ki végzi
- University of Arkansas
- Azonosító
- NCT06173336
- A regiszteradat frissítve
- 2025. június 25.
- Eredeti leírás
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis.A teljes eredeti leírásKevesebb
A Randomized Controlled Prospective Trial Comparing Clinical Outcomes and Efficacy of Single vs. Double Pyloromyotomy Technique for Gastric Peroral Endoscopic Pyloromyotomy (G-POEM) in the Treatment of Gastroparesis
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis.
This will be a randomized controlled trial of all the patients who are referred to the University of Arkansas Medical Sciences (UAMS) for gastric peroral endoscopic pyloromyotomy (G-POEM) for treatment of refractory and severe gastroparesis. During G-POEM procedure, either single or double pyloromyotomy will be performed with randomization. The aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.
Bevonási feltételek: Patients with refractory (persistent symptoms for >6 months refractory to medical therapy) and severe gastroparesis based on GCSI > 2, with confirmed im-paired gastric emptying based on gastric emptying; Persons 18 years or older at the time of signing the informed consent.
Kizáró feltételek: No previous attempt with at least one prokinetic drug; Previous gastric surgery; Malignant or pre-malignant gastric diseases; Esophageal or gastric varices and /or portal gastropathy; Pregnant patients.