Lower Gastrointestinal BleedingNCT07073300
Endoscopic Findings in Patients Presented With Lower GIT Bleeding in Assiut University Hospitals, a Single-centre Study
An observational study of Lower Gastrointestinal Bleeding, run by Assiut University.
Trial summary
Lower gastrointestinal bleeding (LGIB) refers to hematochezia or bright blood passing per rectum of colorectal source distal to ileocecal valve. This differs from the old definition of LGIB which involved small intestine distal to the ligament of Treitz. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lower Gastrointestinal Bleeding
- What is being tested?
- Endoscopy
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2025to 30 Jul 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presents with lower gastrointestinal bleeding
Who may be able to join
- patients with hematochezia and melena. -
Who cannot join
- poor bowel preparation.
- Inco-operative patients.
About this study
Lower gastrointestinal bleeding (LGIB) refers to hematochezia or bright blood passing per rectum of colorectal source distal to ileocecal valve. This differs from the old definition of LGIB which involved small intestine distal to the ligament of Treitz. The new definition of LGIB aligns with current clinical practice and the reality that the majority of LGIB cases come from colorectal origin . In north America, LGIB is one fifth to one third as common as upper gastrointestinal bleeding (UGIB) and represents 30-40 % of all gastrointestinal bleeding cases . 20.5 - 27 cases per 100,000 adults are diagnosed to have LGIB with 21 to 40 cases per 100,000 adults are hospitalized . LGIB has a wide range of aetiologies, presentation and severity. The clinical picture of LGIB depends on patient's age, aetiology and associated comorbidities . Patients can present with overt bleeding in the form of hematochezia which is defined as passage of bright blood per rectum. This should be differentiated from melena (the passage of dark, offensive and digested blood with stool) associated with UGIB . However, 10-15 % of patients with severe acute UGIB can present with hematochezia . In addition, Occult LGIB can present in the form of iron deficiency anaemia or faecal occult bleeding . Causes of LGIB vary significantly according to patient age, lifestyle, dietary habits and geography or race. Some of the most common causes of LGIB include haemorrhoids, colorectal polyps, malignancy, colitis (infective, inflammatory, ischemic, etc.) as well as diverticular disease . However, there are limited data about the common causes of LGIB in upper Egypt.
- Conditions
- Lower Gastrointestinal Bleeding
- Being tested
- Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyDevice
Upper Endoscopy and colonoscopy will be used
| Study group | Role | What they receive |
|---|---|---|
| Patients presented with lower GI bleeding | Patients presented with lower GI bleeding will be investigated with endoscopy to detect different findings Receives: Device: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic detection of colorectal polyps according to paris classification
Paris Classification of Superficial GI Lesions Main Categories Type 0: Superficial Lesions
Divided into 3 main types with subtypes:
- Type 0-I: Protruded (Polypoid) 0-Ip (Pedunculated): Lesion is on a stalk (like a mushroom). 0-Is (Sessile): Broad-based elevation without a stalk.
- Type 0-II: Non-Protruded, Non-Excavated (Flat) 0-IIa (Slightly Elevated): Slight elevation (less than 2.5 mm), often subtle. 0-IIb (Completely Flat): Same level as mucosa, hard to detect without special imaging (e.g., NBI). 0-IIc (Slightly Depressed): A shallow depression; higher risk for malignancy than IIa.
- Type 0-III: Excavated (Ulcerated) True ulceration into the mucosa or deeper. Suggests deeper invasion and higher malignancy risk. Combined Morphologies Lesions can be mixed (e.g., 0-IIa + IIc, or 0-Is + IIa).
Measured: Within 24 hours after endoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Gastrointestinal BleedingStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Mohamed Salah Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073300
- Sponsor's protocol ID
- Endoscopic findings in LGIB
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Findings in Patients Presented With Lower GIT Bleeding in Assiut University Hospitals, a Single-centre Study
- ClinicalTrials.gov ID
- NCT07073300
- Acronym / sponsor ID
- Endoscopic findings in LGIB
- Conditions
- Lower Gastrointestinal Bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 18 Jul 2025 (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.
Lower gastrointestinal bleeding (LGIB) refers to hematochezia or bright blood passing per rectum of colorectal source distal to ileocecal valve. This differs from the old definition of LGIB which involved small intestine distal to the ligament of Treitz. The new definition of LGIB aligns with current clinical practice and the reality that the majority of LGIB cases come from colorectal origin . In north America, LGIB is one fifth to one third as common as upper gastrointestinal bleeding (UGIB) and represents 30-40 % of all gastrointestinal bleeding cases . 20.5 - 27 cases per 100,000 adults are diagnosed to have LGIB with 21 to 40 cases per 100,000 adults are hospitalized . LGIB has a wide range of aetiologies, presentation and severity. The clinical picture of LGIB depends on patient's age, aetiology and associated comorbidities . Patients can present with overt bleeding in the form of hematochezia which is defined as passage of bright blood per rectum. This should be differentiated from melena (the passage of dark, offensive and digested blood with stool) associated with UGIB . However, 10-15 % of patients with severe acute UGIB can present with hematochezia . In addition, Occult LGIB can present in the form of iron deficiency anaemia or faecal occult bleeding . Causes of LGIB vary significantly according to patient age, lifestyle, dietary habits and geography or race. Some of the most common causes of LGIB include haemorrhoids, colorectal polyps, malignancy, colitis (infective, inflammatory, ischemic, etc.) as well as diverticular disease . However, there are limited data about the common causes of LGIB in upper Egypt.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presented with lower GI bleeding | – | Device: EndoscopyPatients presented with lower GI bleeding will be investigated with endoscopy to detect different findings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presents with lower gastrointestinal bleeding
Key inclusion criteria (1 listed)
- patients with hematochezia and melena. -
Key exclusion criteria (2 listed)
- poor bowel preparation.
- Inco-operative patients.
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 |
|---|---|---|
| EndoscopyUpper Endoscopy and colonoscopy will be used | Device | Patients presented with lower GI bleeding |
Primary outcome
Endoscopic detection of colorectal polyps according to paris classification
Time frame: Within 24 hours after endoscopy procedure
Paris Classification of Superficial GI Lesions Main Categories Type 0: Superficial Lesions Divided into 3 main types with subtypes: 1. Type 0-I: Protruded (Polypoid) 0-Ip (Pedunculated): Lesion is on a stalk (like a mushroom). 0-Is (Sessile): Broad-based elevation without a stalk. 2. Type 0-II: Non-Protruded, Non-Excavated (Flat) 0-IIa (Slightly Elevated): Slight elevation (less than 2.5 mm), often subtle. 0-IIb (Completely Flat): Same level as mucosa, hard to detect without special imaging (e.g., NBI). 0-IIc (Slightly Depressed): A shallow depression; higher risk for malignancy than IIa. 3. Type 0-III: Excavated (Ulcerated) True ulceration into the mucosa or deeper. Suggests deeper invasion and higher malignancy risk. Combined Morphologies Lesions can be mixed (e.g., 0-IIa + IIc, or 0-Is + IIa).
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 18 Jul 2025.
Related trials for Lower Gastrointestinal Bleeding
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Urgent Panendoscopy in Patients Presenting With Hematochezia
Lower Gastrointestinal Bleeding, Small Bowel Bleeding
Not yet recruiting
Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract
Lower Gastrointestinal Bleeding, Diverticular Bleeding
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Gastrointestinal Bleeding, 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 2 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: opening soon, as of the sponsor's last update on 18 Jul 2025. 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?
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?
Endoscopic detection of colorectal polyps according to paris classification (time frame: Within 24 hours after endoscopy procedure). 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 18 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.