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RecruitingNCT07252115Updated Nov 26, 2025

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

An interventional study of Laparoscopic total left-sided surgical approach and Laparoscopic traditional bilateral approach in Hernia, Hiatal and GERD (Gastroesophageal Reflux Disease), sponsored by Beijing Friendship Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 7 months after the study started (first participant enrolled Apr 2024, registered Nov 2025).
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hernia, Hiatal
  • GERD (Gastroesophageal Reflux Disease)
03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's planned enrollment of 143 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 217 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 to 85 years.
  • Confirmed diagnosis of hiatal hernia (type I to IV).
  • Diagnosis of 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

Exclusion Criteria:

  • Presence of GERD without a hiatal hernia.
  • Esophageal motility disorder.
  • History of esophageal or other upper abdominal surgery.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
143 participants (estimated)

Study arms

  • Experimental
    laparoscopic total left-sided surgical approach

    Procedure: Laparoscopic total left-sided surgical approach

  • Active comparator
    Laparoscopic traditional bilateral approach

    Procedure: Laparoscopic traditional bilateral approach

Interventions

  • ProcedureLaparoscopic total left-sided surgical approach

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

  • ProcedureLaparoscopic traditional bilateral approach

    The control group adopts the laparoscopic bilateral surgical approach.

06

What researchers measure

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.

    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 outcomes

  1. esophagitis

    varified by gastroscopy (LA-standard)

    Time frame: 1 and 3 years after surgery

  2. 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.

    Time frame: 1 and 3 years after surgery

  3. Incidence of gallstones

    abdominal ultrasonography

    Time frame: postoperative 1 and 3-year

  4. 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.

    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.

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07252115
Responsible party
Sponsor
First posted
Nov 26, 2025
Start date
Apr 4, 2024
Primary completion
Nov 30, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 26, 2025

Study contacts

Jie Yin, Doctoral Degree
Contact
yyyyyj@ccmu.edu.cn
+86 15011302788

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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