Left-sided versus traditional bilateral laparoscopic repair for hiatal hernia with reflux
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
Run by Beijing Friendship Hospital · NCT07252115 · Data updated 2026-11-12
This compares two laparoscopic operations—a left-sided approach and the traditional bilateral approach—to see which helps adults (18–85) with hiatal hernia whose reflux doesn't get better on usual acid‑reducing medicine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 143 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Status | Recruiting |
| Started | April 4, 2024 |
| Main results expected | November 30, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07252115 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–85 with CT- and endoscopy-confirmed hiatal hernia (type I–IV) and reflux symptoms that persist despite 40 mg omeprazole daily for 8–12 weeks, without esophageal motility disorders or prior upper abdominal surgery, are the intended participants.
✕Probably not a fit
Patients without a hiatal hernia, those who respond well to PPIs, those with esophageal motility disorders, or those with prior esophageal or upper abdominal surgery are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional comparison enrolls adults with confirmed hiatal hernia and reflux symptoms that persist despite standard omeprazole therapy. Participants will receive either a laparoscopic total left‑sided surgical approach or a laparoscopic traditional bilateral approach. Outcomes will include symptom control, esophageal acid exposure on 24‑hour pH monitoring, endoscopic findings, quality of life measures, and perioperative complications with scheduled follow‑up. The trial is conducted at Beijing Friendship Hospital with collaborating Beijing centers and excludes patients with esophageal motility disorders or prior upper abdominal surgery.
Why it matters
Potential benefit: If successful, one surgical approach could provide better reflux control and fewer recurrences or reduce the need for long‑term acid medication while maintaining low complication rates.
How similar studies have gone: Anti-reflux surgery is an established option with evidence of symptom control comparable or superior to PPIs, but direct head‑to‑head data comparing left‑sided versus traditional bilateral laparoscopic approaches are limited, so this comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Beijing Friendship Hospital
Beijing, China Recruiting -
Beijing Friendship Hospital
Beijing, China Active not recruiting
Study contacts
- Study coordinator: Jie Yin, Doctoral Degree
- Email: yyyyyj@ccmu.edu.cn
- Phone: +86 15011302788
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.