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Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients

Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06884800
Enrollment
100
Registered
2025-03-19
Start date
2024-08-25
Completion date
2025-12-01
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Toupet Fundoplication, Radiological Negative, Endoscope, Hiatal Hernia

Brief summary

This study aims to assess the feasibility and effectiveness of laparoscopic toupet fundoplication (LTF) for treating gastroesophageal reflux disease (GERD) symptoms and disease-specific Quality of Life (QoL).

Detailed description

Heartburn, regurgitation, dysphagia, and chest pain are regarded as common esophageal symptoms of gastroesophageal reflux disease (GERD). On the other hand, there are very few reports of laryngopharyngeal reflux (LPR), which is associated with persistent upper airway contact, acidic and non-acidic reflux, and aerosol that results in posterior laryngitis, edema, and glottis erythema. Proton-pump inhibitor (PPI) therapy, Laparoscopic Nissen Fundoplication (LNF), and Laparoscopic Toupet Fundoplication (LTF) have been proven to be effective for the treatment of GERD. However, the therapeutic management of patients with hiatal hernia is debated and treatment remains empirical. Previous studies on PPI therapy and LNF had been published with promising but controversial results. Therefore, the role of LTF is even less explored and evidence is scarce

Interventions

Patients will undergo laparoscopic toupet fundoplication.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of recurrence1 year postoperativelyIncidence of recurrence will be recorded

Secondary

MeasureTime frameDescription
Incidence of anatomical failure1 year postoperativelyIncidence of anatomical failure will be recorded
Incidence of complications1 year postoperativelyIncidence of complications such as dysphagia, chest pain on eating, gas-bloat, postprandial fullness, restriction in belching, and increased flatus will be recorded.

Countries

Egypt

Contacts

Primary ContactAbdelrahman M Salah, MD
Abdelrahman.salah@mu.edu.eg00201064746493

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026