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TLSA Versus TBSA Surgical Approach for Hiatal Hernia With Gastroesophageal Reflux Disease

RecruitingNAAges 18 Years - 85 YearsAllBeijing Friendship Hospital
NCT07252115 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Gastroesophageal reflux disease (GERD), characterized by pathological reflux of gastric contents, affects 10%-20% of the global population with Western predominance and escalating incidence over recent decades. Anatomical and functional abnormalities of the esophagogastric junction (EGJ) such as hiatal hernia (HH) is one of the major pathophysiological mechanisms. GERD elevates risks for Barrett esophagus, esophageal adenocarcinoma and interstitial pulmonary fibrosis, while characteristic symptoms including reflux and heartburn substantially impair quality of life (QoL). Proton pump inhibitors (PPIs) are used to alleviate symptoms and prevent reflux-related esophageal mucosal damage, but may cause long-term adverse effects. Anti-reflux surgery (ARS) is a well-established therapeutic option for patients with anatomical abnormalities, chronic PPI-refractory symptoms or unwilling to take l

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18 to 85 years. * Confirmed diagnosis of hiatal hernia (type I to IV). * Diagnosis of refractory GERD, defined as persistent symptoms despite receiving 40 mg daily omeprazole for 8-12 weeks. * GERD confirmed by either: * Increased esophageal acid exposure time (AET) on 24-hour pH monitoring, and/or * Endoscopic evidence of esophagitis. * Hiatal hernia diagnosis verified by both abdominal CT and gastroscopy. Exclusion Criteria: * Presence of GERD without a hiatal hernia. * Esophageal motility disorder. * History of esophageal or other upper abdominal surgery.
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What it tests

  • Laparoscopic total left-sided surgical approach
  • Laparoscopic traditional bilateral approach
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Where

2 sites
Beijing Friendship Hospital
Beijing, China
Beijing Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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