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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hernia, Hiatal; GERD (Gastroesophageal Reflux Disease)
• Intervention / Treatment: Procedure: Laparoscopic total left-sided surgical approach; Procedure: Laparoscopic traditional bilateral approach

• Study Type: Interventional
• Enrollment (Estimated): 143
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Yin, Doctoral Degree; Phone Number: +86 15011302788; Email: yyyyyj@ccmu.edu.cn

Study Locations

• China
  • Beijing, China, 100050
    • Recruiting
    • Beijing Friendship Hospital
    • Contact: Jie Yin, Doctor's degree; Phone Number: +86 yyyyyj@ccmu.edu.cn; Email: yyyyyj@ccmu.edu.cn
  • Beijing, China, 100050
    • Active, not recruiting
    • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic total left-sided surgical approach	Procedure: Laparoscopic total left-sided surgical approach; The intervention group adopts the laparoscopic complete left-sided surgical approach.
Active Comparator: Laparoscopic traditional bilateral approach	Procedure: Laparoscopic traditional bilateral approach; The control group adopts the laparoscopic bilateral surgical approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Quality of Life Index (GLQI)	GIQLI is related to the QOL for gastrointestinal disorders. It contains 5 subscales, with a score range of 0 to 144 points. The higher the score, the better the patient's QOL and the better the surgical effect.	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

Outcome Measure	Measure Description	Time Frame
esophagitis	varified by gastroscopy （LA-standard）	1 and 3 years after surgery
DeMeester score	The DeMeester score is a quantitative index used to distinguish between pathological and physiological acid reflux. It is calculated as a composite score based on multiple parameters derived from 24-hour esophageal pH monitoring, primarily the percentage of time the esophageal pH falls below a threshold of 4. A score greater than 14.7 is indicative of pathological acid reflux, whereas a score below this threshold is considered within the physiological range.	1 and 3 years after surgery
Incidence of gallstones	abdominal ultrasonography	postoperative 1 and 3-year
Gastrointestinal Symptom Rating Scale	The GSRS comprises 15 items, encompassing five symptom domains: Abdominal Pain Syndrome, Indigestion Syndrome, Diarrhea Syndrome, Constipation Syndrome, and Reflux Syndrome. Each item is rated on a 7-point Likert scale (where 1 represents "no symptoms" and 7 represents "very severe symptoms"). Each symptom item is scored individually (1-7), resulting in a total score range of 15 to 105. Higher total or domain scores indicate more pronounced symptoms.	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.

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Xuanwu Hospital, Beijing; Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Internal Hernia; Pathological Conditions, Anatomical; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Hernia; Hernia, Diaphragmatic; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Hernia, Hiatal; Gastroesophageal Reflux
• Other Study ID Numbers: 2024-P2-097-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No