Hiatal hernia
Conditions
Interventions
RC:RC Fundoplication
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75, regardless of gender; 2. Esophageal hiatal hernia was diagnosed by gastroscopy, CT, esophageal barium angiography or high resolution manometry; 3. Presence of typical gastroesophageal reflux disease (GERD) symptoms (heartburn, acid reflux), poor treatment with proton pump inhibitors (PPIs), dependence on PPIs, or reluctance to take long-term medication; 4. One or a combination of the following criteria is met: (1) CT/diaphragmatic esophageal hiatus >= 3 cm on imaging; (2) LES resting pressure (HRM) on high-resolution manometry of the esophagus: = 14.72 points or the number of non-acid reflux is abnormal; (5) Endoscopy indicates gastroesophageal valve GEFV grading Hill grade III or IV; (6) Endoscopy indicates reflux esophagitis LA-B grade and above; 5. The patient or guardian agrees to sign the informed consent form, has good compliance, and cooperates with follow-up.
Exclusion criteria
Exclusion criteria: 1. History of previous esophageal or stomach surgery; 2. Use of mesh during hiatal hernia repair; 3. Presence of surgical contraindications, unable to tolerate surgery or general anesthesia; 4. Confirmed diagnosis of esophageal or gastric malignant tumor; 5. Already diagnosed with severe esophageal motility disorder or experiencing progressive dysphagia, regurgitation of undigested food or liquid, significant weight loss, nighttime cough, with examination confirming severe esophageal motility disorder (such as achalasia, diffuse esophageal spasm); 6. Pregnant or breastfeeding women; 7. Presence of other serious diseases affecting the evaluation of this study, unable to cooperate; 8. Unable to understand the procedures and methods of this clinical study, refuse to participate and refuse to sign the informed consent form;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year postoperative GERD remission rate;Incidence of serious complications within 90 days after surgery;Incidence of dysphagia at 1 year after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| GERD-HRQL score change;GERD-Q score change;Proton pump inhibitor discontinuation rate; | — |
Countries
China
Contacts
Public ContactQiyuan Yao
Huashan Hospital, Fudan University
Outcome results
None listed