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

NCT ID: NCT06884800

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-25
• Study Completion Date: 2025-12-01

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

Conditions

Laparoscopic Toupet Fundoplication; Radiological Negative; Endoscope; Hiatal Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic toupet fundoplication group

Patients will undergo laparoscopic toupet fundoplication.

Group Type: EXPERIMENTAL

Laparoscopic toupet fundoplication

Intervention Type: PROCEDURE

Patients will undergo laparoscopic toupet fundoplication.

Interventions

Laparoscopic toupet fundoplication

Patients will undergo laparoscopic toupet fundoplication.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Mohamed Salah

Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Minia University

Minya, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abdelrahman M Salah, MD

Role: CONTACT

Abdelrahman.salah@mu.edu.eg

00201064746493

Facility Contacts

Abdelrahman M Salah, MD

Role: primary

Abdelrahman.salah@mu.edu.eg

00201064746493

Other Identifiers

1241/08/2024

Identifier Type: -

Identifier Source: org_study_id