Gastroesophageal reflux disease
Conditions
Interventions
Case series:Muse surgery
Sponsors
Shanghai First People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old male and female; 2. Recently (30 days) PH monitoring confirmed GERD, and PPI withdrawal; 3. Have heartburn symptoms for at least two years; 4. PPI treatment for at least 6 months, the symptoms are obviously relieved, when the PPI is stopped, there is obvious gastroesophageal reflux; 5. Esophageal manometry within 30 days showed adequate esophageal peristalsis without motor dysfunction; 6. Patients understand the research requirements and treatment procedures and sign an informed consent form (ICF) before the study begins; 7. Willing to follow all follow-up assessments; 8. In addition to GERD, good health; 9. Have the ability to read and sign ICF.
Exclusion criteria
Exclusion criteria: 1. Endoscopic findings of esophageal hiatus > 3 cm or any size of non-returnable esophageal hiatus hernia; 2. The acid exposure test results are normal (the total time of pH 35; 11. Helicobacter pylori test positive - can be enrolled after radical treatment; 12. Have the following medical history: (1) Any heart disease, NYHA cardiac function classification>1; (2) either of two types of diabetes; (3) endocrine disorders (except for hypothyroidism in drug therapy); (4) history of epilepsy, stroke, Parkinson's disease, muscular atrophic diseases such as ALS or multiple sclerosis; (5) Soft tissue condition (such as amyloidosis) that affects wound healing; (6) History of esophagus/stomach surgery (except for pyloric myotomy in children); (7) Portal hypertension caused by cirrhosis or other causes; (8) autoimmune disease (SLE, scleroderma, dermatomyositis); (9) renal failure (serum creatinine = 1.6); (10) blood disease, or taking anticoagulant drugs (heparin, excluding aspirin), aspirin is discontinued 7 days before the start of treatment and can be recovered after discharge; (11) Any type of cancer except skin cancer, the patient has not received active treatment; (12) has stomach or duodenal ulcer; 13. Recent history of unintentional weight loss; 14. Pregnancy; 15. Any medical factor that the investigator believes will lead to the patient's inability to complete the study; 16. History of alcohol abuse in six months; 17. Patients who participated in or were preparing to participate in other drug trials or equipment trials during the last 30 days or during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reflux symptom; | — |
Secondary
| Measure | Time frame |
|---|---|
| GERD-Q scale score; | — |
Countries
China
Contacts
Public ContactRONG
Shanghai First People's Hospital
Outcome results
None listed