TLSA Versus TBSA Surgical Approach for Hiatal Hernia With Gastroesophageal Reflux Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic total left-sided surgical approach, Laparoscopic traditional bilateral approach.
- Who it may be relevant to
- Registry conditions: Hernia, Hiatal, GERD (Gastroesophageal Reflux Disease). Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Randomized Clinical Trial on the Efficacy and Safety of the Total Left-side Surgical Approach (TLSA) Versus the Traditional Bilateral Surgical Approach (TBSA) for Hiatal Hernia With Gastroesophageal Reflux Disease
Overview
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 lifelong PPIs. It provides comparable or potentially superior efficacy to PPIs, especially in reconstructing anatomical structures and addressing EGJ functional deficiencies. Maximize patients' QoL while minimizing side effects is priority for ARS. Despite advancements in surgical techniques, ARS remains invasive and is associated with inherent mechanical complications, including dysphagia and potential vagus nerve injury. A growing consensus recognizes that hepatic vagus nerve injury, occurring in a significant proportion of patients following ARS, potentially contributes to postoperative dysfunctions such as delayed gastric emptying, impaired reflux control, dyspeptic symptoms, cholelithiasis, ultimately diminishing QoL. Although the traditional bilateral surgical approach (TBSA) is widely used, its requisite dissection of the lesser omentum invariably injures or severs the hepatic branch of the vagus nerve. The hepatic branch of the vagus arises from the anterior trunk and predominantly innervates the gastric antrum, pylorus, proximal duodenum and biliary tract. Functionally, it mediates a spectrum of vital physiological process including hepato-gastric reflexes that facilitate gastric motility via osmotic sensing, as well as glucose-sensitive reflexes that inhibit gastric motility and delay gastric emptying. Furthermore, hepatic branch is involved in food intake and metabolic homeostasis, and it exerts parasympathetic control over the coordinated contraction of the gallbladder and sphincter of Oddi. However, the functional preservation of the hepatic branch of the vagus nerve during ARS remains poorly understood, with limited clinical evidence and absent robust guidelines. Based on our preliminary findings, we initiated a long-term evaluation of the total left-side approach (TLSA), a nerve-sparing strategy that preserves the lesser omentum and hepatogastric ligament to safeguard the hepatic branch of the vagus nerve, with the aim of enhancing postoperative QoL.
Interventions
- Procedure Laparoscopic total left-sided surgical approach
The intervention group adopts the laparoscopic complete left-sided surgical approach. - Procedure Laparoscopic traditional bilateral approach
The control group adopts the laparoscopic bilateral surgical approach.
Primary outcome measures
- Gastrointestinal Quality of Life Index (GLQI) [Time frame: Follow-up begins after surgery, with each patient followed for 3 years at the following time points: 3, 6, 12, 18, 24, and 36 months. Questionnaire surveys are completed at each time point.]
Secondary outcome measures (4)
- esophagitis [Time frame: 1 and 3 years after surgery]
- DeMeester score [Time frame: 1 and 3 years after surgery]
- Incidence of gallstones [Time frame: postoperative 1 and 3-year]
- Gastrointestinal Symptom Rating Scale [Time frame: Follow-up begins after surgery, with each patient followed for 3 years at the following time points: 3, 6, 12, 18, 24, and 36 months. Questionnaire surveys are completed at each time point.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Friendship Hospital — Beijing
- Beijing Friendship Hospital — Beijing
Identifiers
NCT: NCT07252115 · 2024-P2-097-02