Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05851794
Eligibility Criteria:
Inclusion Criteria:
* patients 18≥ years with large sliding hiatus hernia (\> 5 cm) with severe GERD patients (DeMeester score \>100)with typical symptoms and successful medical management (due to quality of life considerations, life-long need medication intake or cost) or patients with unresponsive or inadequate symptom control despite eight weeks of adequate medical therapy with or without extra-esophageal Atypical symptoms that are related to GERD(cough, Globus, or hoarseness) confirmed diagnosis by hypotensive lower esophageal sphincter confirmed by HRM and a positive pH/impedance test (based on DeMeester scores)
* fitness and consenting for surgery
* patients that completed three year follow up period,
* with esophagitis
Exclusion Criteria:
* \<18years,
* pregnancy,
* Patients unfit for surgery \[ comorbid condition like severe cardiac illness, chronic respiratory diseases, chronic renal failure, and bleeding disorder\],
* Non cooperative or lost patients for regular follow up,
* Patients who had undergone previous antireflux surgery or who required a concurrent abdominal procedure at the same time as fundoplication (eg, cholecystectomy), -
* psychiatric disorders.
* esophageal dysmotility,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT05851794
Study Brief:
Protocol Section:
NCT05851794