NCT06047873

Brief Summary

Gastrointestinal bleeding (GIB) is one of the most common conditions in the emergency department. Upper GIB is a major problem that has been decreasing over the past 20 years but still has high mortality rate. GIB usually manifests as hematemesis (vomiting of blood or coffee-ground-like material), melena (black or tarry stools), and hematochezia. UGIB appears as hematemesis in 40%-50%, and as melena or hematochezia in 90%-98%,However, patients with LGIB typically present with hematochezia, but right-sided colonic bleeding or small bowel bleeding may show as melena. Endoscopy is the standard of care in the diagnosis and treatment of UGIB. It helps to identify the source of bleeding, establish the underlying etiology ,achieve hemostasis and provide prognostic information to predict the risk of rebleeding causes of UGIB are broadly divided into variceal and nonvariceal (peptic ulcer disease, reflux esophagitis, gastroduodenal erosions, tumors, vascular ectasia, etc. EGD is the diagnostic modality of choice for UGIB with more sophisticated investigations such as computed tomographic angiography and capsule endoscopy being rarely indicated where endoscopy is inconclusive .The primary diagnostic test for upper GI bleed workup is endoscopy. Sensitivity of 92 % - 98 % and specificity of 30 % - 100 % is present for endoscopy for the diagnosis of upper GI bleed. Severity scoring system like Rockall's score, helps to identify the patients who are at higher risk for rebleed and mortality. Lower gastrointestinal ( GI ) haemorrhage is defined as bleeding distal to the ligament of Treitz. Most of the pathological lesions and haemorrhage in the lower GI tract are usually located in the rectum , sigmoid and left sided colon.It is usually suspected when patients complain of haematochezia (passage of frank bright red blood) or bloody diarrhea.Most of the bleeding from the lower GI tract stops spontaneously and patients usually have favorable outcomes compared to upper GI haemorrhage. However, morbidity and mortality tend to increase in older patients and with other pre existing co morbidities.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 14, 2023

Last Update Submit

September 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • endoscopy in upper and lower gastrointestinal bleeding and percentage of each disorder

    detection of causes of gastrointestinal bleeding and percentage of each cause

    12 months

Study Arms (1)

cases

EXPERIMENTAL
Device: Endoscopy

Interventions

EndoscopyDEVICE

clinical and endoscopic pattern in patients with upper and lower gastrointestinal bleeding

cases

Eligibility Criteria

Age2 Weeks - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children under 18years old who present with upper and lower gastrointestinal bleeding

You may not qualify if:

  • bleeding due to systemic causes

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

Central Study Contacts

Aya B Hussein, Resident

CONTACT

Ashraf M Radwan, Assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-pediatric department-sohag hospital university

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09