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

NCT07252115 | Recruiting DMC

• 1 other identifier: 2024-P2-097-02
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• esophagitis

  1 and 3 years after surgery

• DeMeester score

  1 and 3 years after surgery

• Incidence of gallstones

  postoperative 1 and 3-year

• Gastrointestinal Symptom Rating Scale

  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.

Study Arms (2)

laparoscopic total left-sided surgical approach

EXPERIMENTAL

Procedure: Laparoscopic total left-sided surgical approach

Laparoscopic traditional bilateral approach

ACTIVE COMPARATOR

Procedure: Laparoscopic traditional bilateral approach

Interventions

Laparoscopic total left-sided surgical approach PROCEDURE

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

laparoscopic total left-sided surgical approach

Laparoscopic traditional bilateral approach PROCEDURE

The control group adopts the laparoscopic bilateral surgical approach.

Laparoscopic traditional bilateral approach

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of GERD without a hiatal hernia.
• Esophageal motility disorder.
• History of esophageal or other upper abdominal surgery.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator

Study Sites (2)

Beijing Friendship Hospital

Beijing, 100050, China

ACTIVE NOT RECRUITING

Beijing Friendship Hospital

Beijing, 100050, China

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Jie Yin, Doctoral Degree

CONTACT

+86 15011302788; yyyyyj@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start: April 4, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-04

Locations

CN (2)