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

NCT ID: NCT07252115

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Hernia, Hiatal; GERD (Gastroesophageal Reflux Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

laparoscopic total left-sided surgical approach

Group Type: EXPERIMENTAL

Laparoscopic total left-sided surgical approach

Intervention Type: PROCEDURE

The intervention group adopts the laparoscopic complete left-sided surgical approach.

Laparoscopic traditional bilateral approach

Group Type: ACTIVE_COMPARATOR

Laparoscopic traditional bilateral approach

Intervention Type: PROCEDURE

The control group adopts the laparoscopic bilateral surgical approach.

Interventions

Laparoscopic total left-sided surgical approach

The intervention group adopts the laparoscopic complete left-sided surgical approach.

Intervention Type: PROCEDURE

Laparoscopic traditional bilateral approach

The control group adopts the laparoscopic bilateral surgical approach.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital

Beijing, , China

Site Status: ACTIVE_NOT_RECRUITING

Beijing Friendship Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Yin, Doctoral Degree

Role: CONTACT

yyyyyj@ccmu.edu.cn

+86 15011302788

Facility Contacts

Jie Yin, Doctor's degree

Role: primary

yyyyyj@ccmu.edu.cn

+86 yyyyyj@ccmu.edu.cn

Other Identifiers

2024-P2-097-02

Identifier Type: -

Identifier Source: org_study_id