NCT06884800

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

March 13, 2025

Last Update Submit

March 13, 2025

Conditions

Laparoscopic Toupet FundoplicationRadiological NegativeEndoscopeHiatal Hernia

Outcome Measures

Primary Outcomes (1)

  • Incidence of recurrence

    Incidence of recurrence will be recorded

    1 year postoperatively

Secondary Outcomes (2)

  • Incidence of anatomical failure

    1 year postoperatively

  • Incidence of complications

    1 year postoperatively

Study Arms (1)

Laparoscopic toupet fundoplication group

EXPERIMENTAL

Patients will undergo laparoscopic toupet fundoplication.

Procedure: Laparoscopic toupet fundoplication

Interventions

Laparoscopic toupet fundoplicationPROCEDURE

Patients will undergo laparoscopic toupet fundoplication.

Laparoscopic toupet fundoplication group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61611, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Abdelrahman M Salah, MD

CONTACT

00201064746493Abdelrahman.salah@mu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

August 25, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
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

Locations

EG(1)