Laparoscopic Toupet's Fundoplication: Is it Proper Soluti... | NCT06884800

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Mar 31, 2026Actual

Completion Date

Apr 30, 2026Actual

First Submitted Date

Mar 13, 2025

First Submission Date that Met QC Criteria

Mar 13, 2025

First Posted Date

Mar 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2026

Last Update Posted Date

May 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelrahman Mohamed Salah, Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt., Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic toupet fundoplication group	Experimental	Patients will undergo laparoscopic toupet fundoplication.	Procedure: Laparoscopic toupet fundoplication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic toupet fundoplication	Procedure	Patients will undergo laparoscopic toupet fundoplication.	Laparoscopic toupet fundoplication group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of recurrence	Incidence of recurrence will be recorded	1 year postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Incidence of anatomical failure	Incidence of anatomical failure will be recorded	1 year postoperatively
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minia University		Minya	Minya Governorate	61611	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

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

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006548	Hernia, Diaphragmatic
D000082122	Internal Hernia
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms