NCT04231344

Brief Summary

Study laryngeal disorders by laryngoscopic examination by two physicians on GERD patients diagnosed by gastroenterology department by endoscopy and effect of GERD treatment for 3 months on these laryngeal disorders without any treatment to laryngeal disorders

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

January 14, 2020

Last Update Submit

March 15, 2022

Conditions

Laryngeal Disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of laryngeal disorders in GERD patients

    Laryngoscopic examination of patients with GERD by two otorhinolaryngologist physicians

    One year from February 2020 to February 2021

Secondary Outcomes (1)

  • Effect of treatment of GERD on these laryngeal disorders

    3 months

Interventions

LaryngoscopyDEVICE

Laryngoscopic examination of patients with GERD by two physicians

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who diagnosed GERD by gastroenterology department before start of treatment of GERD Will examine by laryngoscopy for laryngeal lesions then they Will take treatment to GERD by gastroenterology department without any treatment to laryngeal disorders and study effect of GERD treatment on these laryngeal disorders

You may qualify if:

  • Patients diagnosed GERD by gastroenterology department before start of treatment and have laryngeal symptoms

You may not qualify if:

  • voice abusers as singers ,teachers and readers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

Related Publications (2)

  • Cohen JT, Bach KK, Postma GN, Koufman JA. Clinical manifestations of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):19-23.

    PMID: 12353427BACKGROUND

  • Belafsky PC, Postma GN, Amin MR, Koufman JA. Symptoms and findings of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):10-3.

    PMID: 12353425BACKGROUND

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

January 1, 2021

Primary Completion

May 1, 2021

Study Completion

February 1, 2022

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

EG(1)