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Hernia, HiatalNCT07252115

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

A study testing Laparoscopic total left-sided surgical approach and Laparoscopic traditional bilateral approach in people with Hernia, Hiatal and GERD (Gastroesophageal Reflux Disease), run by Beijing Friendship Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Laparoscopic total left-sided surgical approach and Laparoscopic traditional bilateral approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
2 sitesChina
Study dates
4 Apr 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Yin, Doctoral Degree contact

+86 15011302788

yyyyyj@ccmu.edu.cn

China2 sites, 1 recruiting
  • Beijing Friendship Hospital

    Beijing, 100050

    Active, not recruiting
  • Beijing Friendship Hospital

    Beijing, 100050

    Jie Yin, Doctor's degree, +86 yyyyyj@ccmu.edu.cn, yyyyyj@ccmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read more

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.

Being tested
Laparoscopic total left-sided surgical approach, Laparoscopic traditional bilateral approach
Medical subject headings
Hernia, Hiatal, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic total left-sided surgical approachProcedure or surgery

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

  • Laparoscopic traditional bilateral approachProcedure or surgery

    The control group adopts the laparoscopic bilateral surgical approach.

Study groups in NCT07252115
Study groupRoleWhat they receive
laparoscopic total left-sided surgical approachExperimentalNot described
Receives: Procedure: Laparoscopic total left-sided surgical approach
Laparoscopic traditional bilateral approachActive comparatorNot described
Receives: Procedure: Laparoscopic traditional bilateral approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. esophagitis

    varified by gastroscopy (LA-standard)

    Measured: 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.

    Measured: 1 and 3 years after surgery

  3. Incidence of gallstones

    abdominal ultrasonography

    Measured: 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start4 Apr 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
143 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07252115
Sponsor's protocol ID
2024-P2-097-02
Status last verified
Apr 2025
First submitted
17 Nov 2025
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic total left-sided surgical approach and Laparoscopic traditional bilateral approach in people with Hernia, Hiatal and GERD (Gastroesophageal Reflux Disease), run by Beijing Friendship Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Yin, Doctoral Degree (+86 15011302788, yyyyyj@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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