Gastroesophageal reflux disease
Conditions
Interventions
Nissen-Rossetti Group:Laparoscopic Hiatal Hernia Repair + Nissen-Rossetti Fundoplication
W-H Group:Laparoscopic Hiatal Hernia Repair + W-H Fundoplication
Sponsors
PLA Rocket Force Characteristic Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Eligible patients must be aged between (include) 18 and 80 years and meet the following criteria: ? Have typical GERD symptoms such as significant regurgitation (regurgitation of acid and/or food), heartburn, and belching (with or without cough, asthma, and pharyngitis et.al.) for more than 6 months, and PPI dependent for more than 3 months cumulatively; ? Require long-term PPI maintenance therapy or are unsatisfied with the therapeutic effects; ? Have undergone upper gastrointestinal endoscopy in the past 6 months that reveals definite esophagitis with or without hiatal hernia, or have a pathological acid exposure as indicated by a 24-hour pH-impedance monitoring with a DeMeester score of = 14.72 or an percentage of acid exposure time of = 4.5%; ? Have undergo esophageal high-resolution manometry to rule out achalasia, nutcracker esophagus, and esophageal outlet obstruction; ? Agree to participate in the randomized controlled trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: ? A past history of surgery in the esophagus, stomach; ? Patients with coagulation dysfunction, severe cardiopulmonary dysfunction; ? Participated in other clinical studies within the past 3 months; ? Other conditions deemed unsuitable for participation in this clinical research which is assessed by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of dysphagia at 1 year after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| perioperative complication rates;symptom score at 1 year after the operation;subjective relief of symptom at 1 year after the operation;surgical satisfaction rate at 1 year after the operation;off-PPI rate at 1 year after the operation;symptom score for dysphagia at 1 year after the operation;upper gastrointestinal radiography at 1 year after the operation; | — |
Countries
China
Contacts
Public ContactZhiwei Hu
PLA Rocket Force Characteristic Medical Center
Outcome results
None listed