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Efficacy of the Qian-modified Nissen fundoplication for drug-refractory gastroesophageal reflux disease and its impact on dysphagia improvement

Efficacy of the Qian-modified Nissen fundoplication for drug-refractory gastroesophageal reflux disease and its impact on dysphagia improvement

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107622
Enrollment
Unknown
Registered
2025-08-15
Start date
2025-07-09
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux disease

Interventions

Experimental group:laparoscopic Qian-style Nissen fundoplication + highly selective vagotomy + esophageal hiatal hernia repair

Sponsors

The Affiliated Hospital of GuiZhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of the Lyon Consensus 2.0 (2023) for gastroesophageal reflux disease; 2. Previous treatment with standard drugs (PPI twice a day) >=3 months, and the symptoms were not completely relieved; 3. Age 18-75 years old, ASA grade I.-III., no severe cardiopulmonary dysfunction; 4. Sign written informed consent and voluntarily accept Qian's modified Nissen fundoplication.

Exclusion criteria

Exclusion criteria: 1. Abnormal esophageal structure (such as esophageal stricture); 2. Esophageal motility disorders (such as diffuse esophageal spasm, Achalasia); 3. Gastrointestinal tumors or severe cardiovascular/metabolic diseases (such as uncontrolled diabetes, cardiac function grade III.-IV); 4. Coagulation dysfunction (INR>1.5; 5. Severe abdominal infection or long-term use of anticoagulant drugs after surgery; 6. Unable to complete follow-up or refuse to cooperate with the assessment (e.g., high-risk groups with a loss to follow-up rate > 30%).

Design outcomes

Primary

MeasureTime frame
Gastroesophageal Reflux Disease Symptoms;Difficulty swallowing;

Secondary

MeasureTime frame
Surgical Success Rate;Complication Rate;Disease-specific quality of life questionnaire for gastro-oesophageal reflux disease;

Countries

China

Contacts

Public ContactQian Wang

The Affiliated Hospital of GuiZhou Medical University

wq5969@sina.com+86 158 8500 4333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026