Gastroesophageal reflux disease
Conditions
Interventions
Experimental group (ARMS + PECC):ARMS combined with PECC surgery
Control group (?Esomeprazole medication group) :Esomeprazole 20 mg orally once daily
Sponsors
Taikang Xianlin Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older and under 80 years old. 2.Under full-course PPI/P-CAB therapy, symptoms of heartburn, regurgitation and/or chest pain have persisted for at least 3 months with episodes occurring no less than 3 times per week. 3.24-hour ambulatory pH-impedance monitoring: Esophageal acid exposure time =4% 4.FSSG score = 10 points Refractory GERD or PPI-dependent GERD
Exclusion criteria
Exclusion criteria: 1.American Society of Anesthesiologists (ASA) physical status classification is Class III or higher. 2.Previous history of anti-reflux surgery (surgical or endoscopic). 3.Previous history of gastric or esophageal surgery. 4.Hiatal hernia greater than 2 cm. 5.Grade C or D esophagitis. 6.Presence of Barrett's esophagus with dysplasia. 7.Known coagulation disorders. 8.Unable to discontinue anticoagulant drugs. 9.Presence of liver cirrhosis and/or esophageal varices. 10.Presence of esophageal stricture. 11.Presence of eosinophilic esophagitis. 12.Severe esophageal motility disorders such as achalasia and aperistalsis. 13.Presence of connective tissue diseases. 14.Pregnancy at the time of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Symptom Score for GERD (FSSG) at 6 months post-surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastroesophageal Reflux Disease Questionnaire (Gerd-Q) score at 6 months post-surgery;Gastroesophageal Reflux Disease Quality of Life Score (GERD-HRQL)at 6 months post-surgery;Patient subjective satisfaction score;Proportion and dosage of postoperative omeprazole use ; | — |
Countries
China
Contacts
Public ContactZou Xiaoping
Taikang Xianlin Drum Tower Hospital
Outcome results
None listed