Registry of Outcomes From AntiReflux Surgery (NCT02923362) | Clinical Trial Compass
UnknownNot Applicable
Registry of Outcomes From AntiReflux Surgery
United States2,500 participantsStarted 2016-05
Plain-language summary
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be at least 21years of age and at least the minimum Age of Majority according to applicable state law.
* Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery.
* Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)).
* Subject is willing and able to cooperate with follow-up examinations
* Subject has been informed of the study procedures and treatment and has signed an informed consent for the study.
Exclusion Criteria:
* Suspected or confirmed esophageal or gastric cancer.
* Cannot understand trial requirements or is unable to comply with follow-up schedule
* Pregnant or nursing, or plans to become pregnant during the course of the study
* Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
* Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.