Assessing laparoscopic Toupet fundoplication for hiatal hernia patients
Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients
This study is testing if a specific surgery called laparoscopic Toupet fundoplication can help people with hiatal hernias and GERD feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya) |
| Trial ID | NCT06884800 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and effectiveness of laparoscopic Toupet fundoplication (LTF) in treating gastroesophageal reflux disease (GERD) symptoms and improving disease-specific quality of life. It focuses on patients with hiatal hernias that are endoscopically positive but radiologically negative, a group that has limited treatment options. The study aims to provide insights into the role of LTF, given the controversial results of previous treatments like proton-pump inhibitors and laparoscopic Nissen fundoplication. By examining patient outcomes, the study seeks to clarify the therapeutic management of this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with Hill's grade III & IV hiatal hernias that are endoscopically positive but radiologically negative.
Not a fit: Patients who are over 70 years old, recurrent cases, or unfit for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from GERD symptoms associated with hiatal hernias.
How similar studies have performed: Previous studies on laparoscopic fundoplication techniques have shown promising but controversial results, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age above 18 years old. * Both sexes. * Hiatal hernia patients (Hill's grade III \& IV) by endoscopy and negative by radiology indicated for Toupet fundoplication. Exclusion Criteria: * Recurrent patients. * Age above 70 years old * Unfit for surgery
Where this trial is running
Minya
- Minia University — Minya, Egypt (Recruiting)
Study contacts
- Study coordinator: Abdelrahman M Salah, MD
- Email: Abdelrahman.salah@mu.edu.eg
- Phone: 00201064746493
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.