All Patients With Upper GIT Symptoms and Underwent Upper EndoscopyNCT05820061
Pattern Of Endoscopic Findings In Patients Underwent Upper Endoscopy In Sohag University Hospital
A study testing upper endoscopy in people with All Patients With Upper GIT Symptoms and Underwent Upper Endoscopy, run by Sohag University at 1 site in Egypt.
Trial summary
Diseases associated with upper gastrointestinal tract (UGIT) are common and associated with significant morbidity and mortality globally. Peptic ulcer disease, gastroesophageal reflux disease and cancers affect millions of people worldwide. Upper endoscopy used for various diagnostic and therapeutic utic indications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- All Patients With Upper GIT Symptoms and Underwent Upper Endoscopy
- What is being tested?
- upper endoscopy
- How many people
- 800 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Absolute Contraindications
- Perforated bowel.
- Peritonitis.
- Toxic megacolon in an unstable patient. Relative Contraindications
- Severe neutropenia.
- Coagulopathy.
- Severe thrombocytopenia or impaired platelet function.• Increased risk of perforation including connective tissue disorders, recent bowel surgery or bowel obstruction.
- Aneurysm of the abdominal and iliac aorta
Trial locations and contacts
1 site in 1 country.
About this study
Diseases associated with upper gastrointestinal tract (UGIT) are common and associated with significant morbidity and mortality globally. Peptic ulcer disease, gastroesophageal reflux disease and cancers affect millions of people worldwide.
Upper endoscopy used for various diagnostic and therapeutic utic indications.
Read the detailed description
Upper GI symptoms are common complaints among the general population and the underlying diseases associated with them carrey significant morbidit.To the best of our knowledge , there is few data about the prevalence rate of various endoscopic findings among Egyptian ptients with UGI symptoms.
Upper gastrointestinal endoscopy (UGIE) is a valuable tool in the diagnosis and management of diseases affecting the esophagus, stomach and upper parts of the duodenum . In addition to direct inspection of the mucosa, endoscopies can be used for therapeutic interventions. Standard diagnostic indications for UGIE include upper gastrointestinal bleeding, evaluation of persistent epigastric pain despite an appropriate trial of therapy, persistent vomiting, dysphagia, anemia, symptoms or signs suggesting structural disease (e.g., anorexia, weight loss,),new onset dyspepsia in a patient older than 50 years of age, heartburn, oesophageal reflux symptoms that persist or recur despite appropriate therapy, surveillance of malignancy, and screening for oesophageal varices in cirrhotic patients. Therapeutic indications include Esophageal variceal ligation, upper GI bleeding control, foreign body removal, dilation or stenting of strictures, placement of feeding tubes, management of achalasia and endoscopic mucosal resection (EMR).
- Being tested
- upper endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper endoscopyDiagnostic test
data will be collected from the enoscopy archive files in Department of Tropical Medicine and Gastroenterology,Sohag University Hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
spectrum of distribution of endoscopic findings
To assess endoscopic findings in patients presented with upper gastrointestinal symptoms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Patients With Upper GIT Symptoms and Underwent Upper EndoscopyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Hassan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820061
- Sponsor's protocol ID
- Soh-Med-23-03-04MS
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern Of Endoscopic Findings In Patients Underwent Upper Endoscopy In Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05820061
- Acronym / sponsor ID
- Soh-Med-23-03-04MS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Apr 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.
Diseases associated with upper gastrointestinal tract (UGIT) are common and associated with significant morbidity and mortality globally. Peptic ulcer disease, gastroesophageal reflux disease and cancers affect millions of people worldwide.
Upper endoscopy used for various diagnostic and therapeutic utic indications.
Detailed description
Upper GI symptoms are common complaints among the general population and the underlying diseases associated with them carrey significant morbidit.To the best of our knowledge , there is few data about the prevalence rate of various endoscopic findings among Egyptian ptients with UGI symptoms.
Upper gastrointestinal endoscopy (UGIE) is a valuable tool in the diagnosis and management of diseases affecting the esophagus, stomach and upper parts of the duodenum . In addition to direct inspection of the mucosa, endoscopies can be used for therapeutic interventions. Standard diagnostic indications for UGIE include upper gastrointestinal bleeding, evaluation of persistent epigastric pain despite an appropriate trial of therapy, persistent vomiting, dysphagia, anemia, symptoms or signs suggesting structural disease (e.g., anorexia, weight loss,),new onset dyspepsia in a patient older than 50 years of age, heartburn, oesophageal reflux symptoms that persist or recur despite appropriate therapy, surveillance of malignancy, and screening for oesophageal varices in cirrhotic patients. Therapeutic indications include Esophageal variceal ligation, upper GI bleeding control, foreign body removal, dilation or stenting of strictures, placement of feeding tubes, management of achalasia and endoscopic mucosal resection (EMR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Absolute Contraindications
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 endoscopydata will be collected from the enoscopy archive files in Department of Tropical Medicine and Gastroenterology,Sohag University Hospital | Diagnostic test | – |
Primary outcome
spectrum of distribution of endoscopic findings
Time frame: 2 years
To assess endoscopic findings in patients presented with upper gastrointestinal symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper endoscopy in people with All Patients With Upper GIT Symptoms and Underwent Upper Endoscopy, run by Sohag University at 1 site in Egypt.
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 0 inclusion and 8 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: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spectrum of distribution of endoscopic findings (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023.