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OpenTrials
Completed

NCT Number: NCT06884800

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

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).

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Key information

Conditions

Laparoscopic Toupet Fundoplication Endoscope Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Radiological Negative

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, Minya Governorate, 61611, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Toupet fundoplication

Procedure

Patients will undergo laparoscopic toupet fundoplication.

Primary outcomes

  1. Incidence of recurrence

    Time frame: 1 year postoperatively

    Incidence of recurrence will be recorded

Secondary outcomes

  1. Incidence of anatomical failure

    Time frame: 1 year postoperatively

    Incidence of anatomical failure will be recorded

  2. Incidence of complications

    Time frame: 1 year postoperatively

    Incidence of complications such as dysphagia, chest pain on eating, gas-bloat, postprandial fullness, restriction in belching, and increased flatus will be recorded.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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