Hiatus HerniaNCT06155851
Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy
An observational study of Hiatus Hernia, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hiatus Hernia
- What is being tested?
- Upper Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: all cases matching inclusion criteria during the time of the study will be enrolled
Who may be able to join
- 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)
Who cannot join
- Complete PPI responder. Patient with any contraindication for endoscopy . Refusal of participation
Trial locations and contacts
No sites are listed yet.
Mohamed Omar Abdelmalek, Prof contact
About this study
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.
- Conditions
- Hiatus Hernia
- Being tested
- Upper Endoscopy
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper EndoscopyProcedure or surgery
Endescopy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: prospective cohort syudy_ up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hiatus HerniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ibrahim Aboelela, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155851
- Sponsor's protocol ID
- Prevalence of Hiatus Hernia in
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 219227Daraz B, Piela A. [Treatment and prevention of EPH-gestosis]. Pieleg Polozna. 1978;(5):7-8. No abstract available. Polish.
PubMed 254272Kromer W, Freundt KJ. [In vitro inhibition of oxidative N-demethylation with carbon disulfide]. Arzneimittelforschung. 1976 Feb;26(2):189-94. German.
PubMed 7280Newton 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 2756Herold 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy
- ClinicalTrials.gov ID
- NCT06155851
- Acronym / sponsor ID
- Prevalence of Hiatus Hernia in
- Conditions
- Hiatus Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all cases matching inclusion criteria during the time of the study will be enrolled
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Complete PPI responder. Patient with any contraindication for endoscopy . Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper EndoscopyEndescopy | Procedure or surgery | – |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 219227Levin 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.
- Background: PubMed 254272Daraz B, Piela A. [Treatment and prevention of EPH-gestosis]. Pieleg Polozna. 1978;(5):7-8. No abstract available. Polish.
- Background: PubMed 7280Kromer W, Freundt KJ. [In vitro inhibition of oxidative N-demethylation with carbon disulfide]. Arzneimittelforschung. 1976 Feb;26(2):189-94. German.
- Background: PubMed 2756Newton 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.
- Background: PubMed 107121Herold G, Stephan B, Menzel T. [The behavior of bioelements during long-term parenteral feeding]. Infusionsther Klin Ernahr. 1979 Apr;6(2):105-10. German.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Omar Abdelmalek, Prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Hiatus Hernia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Ibrahim abo el ela, Resident (01096265575, asoraibrahim8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155851, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.