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

Last updated: March 13, 2025
Sponsor: Minia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Heartburn

Treatment

Laparoscopic toupet fundoplication

Clinical Study ID

NCT06884800
1241/08/2024
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age above 18 years old.

  • Both sexes.

  • Hiatal hernia patients (Hill's grade III & IV) by endoscopy and negative byradiology indicated for Toupet fundoplication.

Exclusion

Exclusion Criteria:

  • Recurrent patients.

  • Age above 70 years old

  • Unfit for surgery

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Laparoscopic toupet fundoplication
Phase:
Study Start date:
August 25, 2024
Estimated Completion Date:
December 01, 2025

Study 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

Connect with a study center

  • Minia University

    Minya, 61611
    Egypt

    Active - Recruiting

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