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Not yet recruitingNCT06155851Updated Dec 5, 2023

Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy

An observational study in Hiatus Hernia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Gastro-esophageal reflux disease (GERD) is a common problem for which patients seek care from a broad array of primary care providers, medical sub-specialists, and surgeons.

It is estimated that 10 to 20 percent of people in Western countries have GERD, when defined as heartburn or regurgitation at least once a week. (Chapelle, et al. 2021)

The practice guidelines for GERD recommend diagnostic testing in the presence of alarm symptoms, which include dysphagia, odynophagia, weight loss, gastrointestinal bleeding, and anemia.

A detailed history of the pattern, severity, and duration of alarm symptoms is essential. (Katz, et al., 2022) Hiatus hernia refers to condition in which elements of the abdominal cavity, most commonly the stomach, herniate through the esophageal hiatus into the mediastinum.

Hiatus hernia is a frequent finding during upper gastrointestinal endoscopy. Type I hiatal hernia is the sliding hiatal hernia, which accounts for more than 95% of all hiatal hernias with the remaining 5% being Para-esophageal hiatus hernias (Kotekar, et al 2021)

Endoscopy is a common diagnostic tool in the evaluation of patients with upper gastrointestinal pathology, specifically gastroesophageal reflux disease (GERD) and hiatal hernia.

The relationship between these two disease processes are relatively intertwined and have clinical significance given the fact patients with hiatal hernia may be more likely to have acid reflux and there is a close relationship with hiatal hernia size and incidence of reflux disease. (Gomaa, et al 2022) Worldwide, it is believed that the relation between hiatus hernia and gastro-esophageal reflux disease (GERD) have varied considerably.

In our locality the prevalence of hiatal hernia in GERD patients and the effect of hiatal hernia on the severity of GERD symptoms is unknown.

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Conditions studied

  • Hiatus 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 planned enrollment of 100 is below the median of 151 across 29 observational studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Complete PPI responder. Patient with any for endoscopy . Refusal of participation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • ProcedureUpper Endoscopy

    Endescopy

06

What researchers measure

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.

    Time frame: prospective cohort syudy_ up to 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 219227 ↗
  • Daraz B, Piela A. [Treatment and prevention of EPH-gestosis]. Pieleg Polozna. 1978;(5):7-8. No abstract available. Polish. PubMed 254272 ↗
  • Kromer W, Freundt KJ. [In vitro inhibition of oxidative N-demethylation with carbon disulfide]. Arzneimittelforschung. 1976 Feb;26(2):189-94. German. PubMed 7280 ↗
  • 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. PubMed 2756 ↗
  • 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. PubMed 107121 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06155851
Lead sponsor
Assiut University
Responsible party
Esraa Ibrahim Aboelela (resident doctor, Assiut University) — Principal investigator
First posted
Dec 5, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Dec 5, 2023

Study contacts

Esraa Ibrahim abo el ela, Resident
Contact
asoraibrahim8@gmail.com
01096265575
Mohamed Omar Abdelmalek, Prof
Contact
01007343214

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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