NCT06155851

Brief Summary

To study the prevalence of hiatus hernia in GERD patients underwent upper endoscopy To study the effect of hiatus hernia on the severity of GERD symptoms.

Trial Health

35
At Risk

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 all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

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

September 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

September 11, 2023

Last Update Submit

November 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • To study the prevalence of hiatus hernia in GERD patients underwent upper endoscopy To study the effect of hiatus hernia on the severity of GERD symptoms.

    To study the prevalence of hiatus hernia in GERD patients underwent upper endoscopy To study the effect of hiatus hernia on the severity of GERD symptoms.

    prospective cohort syudy_ up to 1 year

Interventions

Endescopy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all cases matching inclusion criteria during the time of the study will be enrolled

You may qualify if:

  • Aged 18 years or older, Patients with GERD symptoms who don't respond to PPI therapy (8 weeks ) or cases with alarm symptoms (dysphagia, anemia ,vomiting , weight loss , GI bleeding , onset of symptoms in old age ,..etc)

You may not qualify if:

  • Complete PPI responder. Patient with any contraindication for endoscopy . Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Levin JG, Seidman JG. Selective packaging of host tRNA's by murine leukemia virus particles does not require genomic RNA. J Virol. 1979 Jan;29(1):328-35. doi: 10.1128/JVI.29.1.328-335.1979.

    PMID: 219227BACKGROUND
  • Daraz B, Piela A. [Treatment and prevention of EPH-gestosis]. Pieleg Polozna. 1978;(5):7-8. No abstract available. Polish.

    PMID: 254272BACKGROUND
  • Kromer W, Freundt KJ. [In vitro inhibition of oxidative N-demethylation with carbon disulfide]. Arzneimittelforschung. 1976 Feb;26(2):189-94. German.

    PMID: 7280BACKGROUND
  • Newton JM, Razzo RN. Proceedings: The influence of formulation variables on the in vitro release of drug from hard gelatin capsules. J Pharm Pharmacol. 1975 Dec;27 Suppl?-2:79P. No abstract available.

    PMID: 2756BACKGROUND
  • Herold G, Stephan B, Menzel T. [The behavior of bioelements during long-term parenteral feeding]. Infusionsther Klin Ernahr. 1979 Apr;6(2):105-10. German.

    PMID: 107121BACKGROUND

MeSH Terms

Conditions

Hernia, Hiatal

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Esraa Ibrahim abo el ela, Resident

CONTACT

Mohamed Omar Abdelmalek, Prof

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 11, 2023

First Posted

December 5, 2023

Study Start

December 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

December 5, 2023

Record last verified: 2023-11