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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06155851
Collaborator
(none)
100
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Upper Endoscopy

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  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. [prospective cohort syudy_ up to 1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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:
  • Complete PPI responder. Patient with any contraindication for endoscopy . Refusal of participation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Esraa Ibrahim Aboelela, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06155851
Other Study ID Numbers:
  • Prevalence of Hiatus Hernia in
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023