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CompletedNCT06884800Updated May 20, 2026

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

An interventional study of Laparoscopic toupet fundoplication in Laparoscopic Toupet Fundoplication, Radiological Negative and Endoscope, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

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).

Read the 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

02

Conditions studied

  • Laparoscopic Toupet Fundoplication
  • Radiological Negative
  • Endoscope
  • Hiatal Hernia

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03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Recurrent patients.
  • Age above 70 years old
  • Unfit for surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Laparoscopic toupet fundoplication group

    Patients will undergo laparoscopic toupet fundoplication.

    Procedure: Laparoscopic toupet fundoplication

Interventions

  • ProcedureLaparoscopic toupet fundoplication

    Patients will undergo laparoscopic toupet fundoplication.

06

What researchers measure

Primary outcomes

  1. Incidence of recurrence

    Incidence of recurrence will be recorded

    Time frame: 1 year postoperatively

Secondary outcomes

  1. Incidence of anatomical failure

    Incidence of anatomical failure will be recorded

    Time frame: 1 year postoperatively

  2. Incidence of complications

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

    Time frame: 1 year postoperatively

07

Study locations

1 site
  • Minia University
    Minya, Minya Governorate 61611, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in Mar 2026, 17 months.

Of 33 interventional studies with no phase under Hernia, Hiatal, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2025
First posted
Mar 19, 2025
StartActual
Oct 1, 2024
Primary completionActual
Mar 31, 2026
CompletionActual
Apr 30, 2026
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06884800
Lead sponsor
Minia University
Responsible party
Abdelrahman Mohamed Salah (Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt., Minia University) — Principal investigator
First posted
Mar 19, 2025
Start date
Oct 1, 2024
Primary completion
Mar 31, 2026
Completion
Apr 30, 2026
Last update
May 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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