GIT BleedingNCT07829978
Impact of Diagnostic and Therapeutic Upper and Lower Gastrointestinal Endoscopic Management on Critically Ill Patients in Fayoum University Hospitals
An observational study of GIT Bleeding, run by Fayoum University at 1 site in Egypt.
Trial summary
Prospective study to evaluate the diagnostic and prognostic value of upper and lower gastrointestinal endoscopy in ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIT Bleeding
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2025to 1 Jan 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who admitted to the ICU with indication for upper and lower gastrointestinal endoscopy from January 2025 to January 2027 in Fayoum University Hospitals will be included.
Who may be able to join
- Critically ill Patients with overt gastrointestinal bleeding
- Critically ill Patients with suspected gastrointestinal bleeding manifestations as:
- Acute and unexplained anemia
- Sudden unexplained hemodynamic instability
- Prolonged Ryle feeding (10 days)
- Prolonged intubation (7 days)
Show all 20Show fewer
- Prolonged hospitalization with occult blood in stool
- Prolonged administration of anticoagulants (2 weeks)
- Prolonged PPI treatment and history of peptic ulcer
- Critically ill Patients with other indications as:
- Immunocompromised patients with oral candidiasis
- Persistent unexplained vomiting
- Dysphagia and odynophagia
- Intractable or chronic gastro esophageal reflux disease
- Chronic unexplained diarrhea
- Unexplained Iron deficiency anemia in old age
- Suspicion of malignant ulcer (peptic or colonic)
- Cancer of unknown origin
- Duodenal biopsy
- Suspicion of colonic mass
Who cannot join
- Patient refusal
- Noncompliance
- Facial trauma
- Patient age less than 18 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Fayoum University
Al Fayyum, Faiyum Governorate, 63521
About this study
Prospective study to evaluate the diagnostic and prognostic value of upper and lower gastrointestinal endoscopy in ICU
Read the detailed description
Prospective study to evaluate the diagnostic and prognostic value of upper and lower gastrointestinal endoscopy in management of Critically ill patients with overt or suspected gastrointestinal bleeding as well as other indications in Critical Care Department of Fayoum University Hospitals
- Conditions
- GIT Bleeding
- Keywords
- gastrointestinal endoscopy, colonoscopy, GIT Bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| overt gastrointestinal bleeding | Critically ill Patients with overt gastrointestinal bleeding | |
| Critically ill Patients with other indications | Critically ill Patients with other indications as: * Immunocompromised patients with oral candidiasis * Persistent unexplained vomiting * Dysphagia and odynophagia * Intractable or chronic gastro esophageal reflux disease * Chronic unexplained diarrhea * Unexplained Iron deficiency anemia in old age * Suspicion of malignant ulcer (peptic or colonic) * Cancer of unknown origin * Duodenal biopsy * Suspicion of colonic mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of urgent gastrointestinal endoscopy
Percentage of critically ill patients undergoing urgent upper and/or lower gastrointestinal endoscopy in whom the procedure establishes a clinically relevant gastrointestinal diagnosis.
Measured: within 24 hours of the endoscopic procedure
Therapeutic yield of urgent gastrointestinal endoscopy
Percentage of critically ill patients undergoing urgent upper and/or lower gastrointestinal endoscopy in whom an endoscopic therapeutic intervention is performed.
Measured: During the endoscopic procedure
Secondary outcomes (4)
Length of ICU stay
Duration of ICU hospitalization from ICU admission until ICU discharge or death.
Measured: up to 28 days
Morbidity
Percentage of patients experiencing procedure-related or gastrointestinal-related complications during the ICU stay.
Measured: up to 28 days
ICU mortality
Percentage of patients who die during the ICU stay
Measured: up to 28 days
Therapeutic intervention rate
Percentage of patients in whom endoscopy results in a therapeutic intervention, such as endoscopic hemostasis or other endoscopic treatment.
Measured: During the endoscopic procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start5 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIT BleedingStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- 60 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamada Ali Abd El Salam Abd El Latif, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829978
- Sponsor's protocol ID
- D 403
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diagnostic and Therapeutic Upper and Lower Gastrointestinal Endoscopic Management on Critically Ill Patients in Fayoum University Hospitals
- ClinicalTrials.gov ID
- NCT07829978
- Acronym / sponsor ID
- D 403
- Conditions
- GIT Bleeding
- Keywords
- gastrointestinal endoscopy, colonoscopy, GIT Bleeding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Sep 2026 (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.
Prospective study to evaluate the diagnostic and prognostic value of upper and lower gastrointestinal endoscopy in ICU
Detailed description
Prospective study to evaluate the diagnostic and prognostic value of upper and lower gastrointestinal endoscopy in management of Critically ill patients with overt or suspected gastrointestinal bleeding as well as other indications in Critical Care Department of Fayoum University Hospitals
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| overt gastrointestinal bleeding | – | –Critically ill Patients with overt gastrointestinal bleeding |
| Critically ill Patients with other indications | – | –Critically ill Patients with other indications as: * Immunocompromised patients with oral candidiasis * Persistent unexplained vomiting * Dysphagia and odynophagia * Intractable or chronic gastro esophageal reflux disease * Chronic unexplained diarrhea * Unexplained Iron deficiency anemia in old age * Suspicion of malignant ulcer (peptic or colonic) * Cancer of unknown origin * Duodenal biopsy * Suspicion of colonic mass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who admitted to the ICU with indication for upper and lower gastrointestinal endoscopy from January 2025 to January 2027 in Fayoum University Hospitals will be included.
Key inclusion criteria (20 listed)
- Critically ill Patients with overt gastrointestinal bleeding
- Critically ill Patients with suspected gastrointestinal bleeding manifestations as:
- Critically ill Patients with other indications as:
Key exclusion criteria (4 listed)
- Patient refusal
- Noncompliance
- Facial trauma
- Patient age less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic yield of urgent gastrointestinal endoscopy
Time frame: within 24 hours of the endoscopic procedure
Percentage of critically ill patients undergoing urgent upper and/or lower gastrointestinal endoscopy in whom the procedure establishes a clinically relevant gastrointestinal diagnosis.
Therapeutic yield of urgent gastrointestinal endoscopy
Time frame: During the endoscopic procedure
Percentage of critically ill patients undergoing urgent upper and/or lower gastrointestinal endoscopy in whom an endoscopic therapeutic intervention is performed.
4 secondary outcomes
Length of ICU stay
Time frame: up to 28 days
Morbidity
Time frame: up to 28 days
ICU mortality
Time frame: up to 28 days
Therapeutic intervention rate
Time frame: During the endoscopic procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for GIT Bleeding
Not yet recruitingObservational study
HALP as a Novel Score for Prediction of Mortality and re_bleeding in Upper GIT Bleeding
Upper Gastrointestinal Bleeding
Not yet recruitingObservational study
Endoscopic Findings in Patients Presented With Lower GIT Bleeding in Assiut University Hospitals, a Single-centre Study
Lower Gastrointestinal Bleeding
Not yet recruitingObservational study
Liberal Versus Restrictive Transfusion Strategy in Patients With Upper Git Bleeding
Upper Git Bleeding
Not yet recruitingObservational study
Endoscopic Findings in Patients With Upper GIT Bleeding
GIT - Gastrointestinal Tract Hemorrhage
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?
An observational study of GIT Bleeding, run by Fayoum 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 20 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic yield of urgent gastrointestinal endoscopy (time frame: within 24 hours of the endoscopic procedure). The study lists 2 primary outcomes in all. 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 21 Sep 2026.