Left-sided versus traditional bilateral laparoscopic repair for hiatal hernia with reflux
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 143 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT07252115 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing and 1 other locations
- Beijing Friendship Hospital — Beijing, China (Active_not_recruiting)
- Beijing Friendship Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jie Yin, Doctoral Degree
- Email: yyyyyj@ccmu.edu.cn
- Phone: +86 15011302788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.