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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT04335734
Eligibility Criteria:
Inclusion Criteria:
* Age: 20 - 80 years;
* Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
* HH type I, II
Exclusion Criteria:
* Age \< 20 years and \> 80 years;
* Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
* HH type III, IV;
* BMI \< 16 and \> 45 kg/m²;
* Pregnancy (in females);
* Oesophageal motility disorders;
* Oesophageal peptic strictures;
* Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);
* History of oesophageal/gastric/duodenal surgery including vagotomy;
* Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT04335734
Study Brief:
Protocol Section:
NCT04335734