HaematocheziaNCT07157228
Clinical Characteristics, Etiologies, and Outcomes of Patients With Haematochezia at Al-Rajhi University Hospital.
An observational study of Haematochezia, run by Assiut University.
Trial summary
Haematochezia is the passage of bright red or maroon blood or blood clots from the rectum, usually originates from a source in lower parts of the gastrointestinal (GI) tract In addition, haematochezia can be seen in patients with brisk upper gastrointestinal bleeding (UGIB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haematochezia
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Oct 2026
- 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 >18 years old presenting at the GIT Endoscopy Unit withfresh bleeding per rectum or admitted at Tropical Medicine \& Gastroenterology Department, Al-Rajhi
Who may be able to join
- patients >18 years old presenting at the GIT Endoscopy Unit withfresh bleeding per rectum or admitted at Tropical Medicine \& Gastroenterology Department, Al-Rajhi University Hospital in a period of one year.
Who cannot join
- Patients younger than 18 years old.
- Patients with isolated melena without haematochezia.
- Patients who refuse colonoscopy
- Patients who refuse to participate in the study.
About this study
Haematochezia is the passage of bright red or maroon blood or blood clots from the rectum, usually originates from a source in lower parts of the gastrointestinal (GI) tract
- In addition, haematochezia can be seen in patients with brisk upper gastrointestinal bleeding (UGIB). The underlying etiology can vary from life threatening variceal bleeding to clinically insignificant haemorrhoidal bleeding . The most common etiology is diverticular bleeding, which accounts for 20% to 55% of cases, followed by intestinal ischemia, inflammatory bowel diseases, anorectal disorders, and neoplasia, which each accounting for around 10% of cases
- LGIB can be mild and intermittent or moderate or severe . Patients with mild bleeding can be electively evaluated as outpatients. While, those with severe bleeding should be hospitalized for management Acute or severe LGIB has an incidence of 20-30 cases/100,000 person years and accounts for 20% of GI bleeds (7-8). The overall mortality rate of LGIB is 2-4% .
Read more
Clinical data available at the time of initial patient evaluation can be used to identify patients at high risk for severe bleeding and other adverse outcomes. Several scoring systems have been developed to assess risk in acute LGIB .
To the best of our knowledge, no Egyptian study has addressed the outcome of patients with haematochezia presented at the endoscopy units or has evaluated the clinical utility of risk scores in assessment of patients admitted to hospitals with acute haematochezia. Therefore, we need to study the short-term outcomes of patients with haematochezia (and their predictors) after being managed.
- Conditions
- Haematochezia
- Medical subject headings
- Gastrointestinal Hemorrhage
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 |
|---|---|---|
| study group | patients >18 years old presenting at the GIT Endoscopy Unit with fresh bleeding per rectum or admitted at Tropical Medicine \& Gastroenterology Department, Al-Rajhi University Hospital in a period of one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the incidance of haematochezia in patients presented to Al-Rajhi University Hospital.
To identify the incidance of haematochezia in patients presented to Al-Rajhi University Hospital.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaematocheziaStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Rashad Mohamed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157228
- Sponsor's protocol ID
- Haematochezia CP.etiology.out
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Etiologies, and Outcomes of Patients With Haematochezia at Al-Rajhi University Hospital.
- ClinicalTrials.gov ID
- NCT07157228
- Acronym / sponsor ID
- Haematochezia CP.etiology.out
- Conditions
- Haematochezia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Sep 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.
Haematochezia is the passage of bright red or maroon blood or blood clots from the rectum, usually originates from a source in lower parts of the gastrointestinal (GI) tract
- In addition, haematochezia can be seen in patients with brisk upper gastrointestinal bleeding (UGIB). The underlying etiology can vary from life threatening variceal bleeding to clinically insignificant haemorrhoidal bleeding . The most common etiology is diverticular bleeding, which accounts for 20% to 55% of cases, followed by intestinal ischemia, inflammatory bowel diseases, anorectal disorders, and neoplasia, which each accounting for around 10% of cases
- LGIB can be mild and intermittent or moderate or severe . Patients with mild bleeding can be electively evaluated as outpatients. While, those with severe bleeding should be hospitalized for management Acute or severe LGIB has an incidence of 20-30 cases/100,000 person years and accounts for 20% of GI bleeds (7-8). The overall mortality rate of LGIB is 2-4% .
Clinical data available at the time of initial patient evaluation can be used to identify patients at high risk for severe bleeding and other adverse outcomes. Several scoring systems have been developed to assess risk in acute LGIB .
To the best of our knowledge, no Egyptian study has addressed the outcome of patients with haematochezia presented at the endoscopy units or has evaluated the clinical utility of risk scores in assessment of patients admitted to hospitals with acute haematochezia. Therefore, we need to study the short-term outcomes of patients with haematochezia (and their predictors) after being managed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients >18 years old presenting at the GIT Endoscopy Unit with fresh bleeding per rectum or admitted at Tropical Medicine \& Gastroenterology Department, Al-Rajhi University Hospital in a period of one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients >18 years old presenting at the GIT Endoscopy Unit withfresh bleeding per rectum or admitted at Tropical Medicine \& Gastroenterology Department, Al-Rajhi
Key inclusion criteria (1 listed)
- patients >18 years old presenting at the GIT Endoscopy Unit withfresh bleeding per rectum or admitted at Tropical Medicine \& Gastroenterology Department, Al-Rajhi University Hospital in a period of one year.
Key exclusion criteria (4 listed)
- Patients younger than 18 years old.
- Patients with isolated melena without haematochezia.
- Patients who refuse colonoscopy
- Patients who refuse to participate in the study.
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
To identify the incidance of haematochezia in patients presented to Al-Rajhi University Hospital.
Time frame: baseline
To identify the incidance of haematochezia in patients presented to Al-Rajhi University Hospital.
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 5 Sep 2025.
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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.
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 Haematochezia, 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 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: opening soon, as of the sponsor's last update on 5 Sep 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?
To identify the incidance of haematochezia in patients presented to Al-Rajhi University Hospital. (time frame: baseline). 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 5 Sep 2025.