NCT07073300

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Jul 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

June 27, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

June 27, 2025

Last Update Submit

July 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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: 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).

    Within 24 hours after endoscopy procedure

Study Arms (1)

Patients presented with lower GI bleeding

Patients presented with lower GI bleeding will be investigated with endoscopy to detect different findings

Device: Endoscopy

Interventions

EndoscopyDEVICE

Upper Endoscopy and colonoscopy will be used

Patients presented with lower GI bleeding

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presents with lower gastrointestinal bleeding

You may qualify if:

  • patients with hematochezia and melena. -

You may not qualify if:

  • poor bowel preparation.
  • Inco-operative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 18, 2025

Study Start

July 25, 2025

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

July 18, 2025

Record last verified: 2025-07