Clinical and Endoscopic Pattern in Children Presented With Upper and Lower Gastrointestinal Bleeding Insohag University Hospital
Primary Purpose
Upper and Lower Gastrointestinal Bleeding
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Upper and Lower Gastrointestinal Bleeding
Eligibility Criteria
Inclusion Criteria: children under 18years old who present with upper and lower gastrointestinal bleeding Exclusion Criteria: bleeding due to systemic causes
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cases
Arm Description
Outcomes
Primary Outcome Measures
endoscopy in upper and lower gastrointestinal bleeding and percentage of each disorder
detection of causes of gastrointestinal bleeding and percentage of each cause
Secondary Outcome Measures
Full Information
NCT ID
NCT06047873
First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Sohag University
1. Study Identification
Unique Protocol Identification Number
NCT06047873
Brief Title
Clinical and Endoscopic Pattern in Children Presented With Upper and Lower Gastrointestinal Bleeding Insohag University Hospital
Official Title
Clinical and Endoscopic Pattern in Children Presented With Upper and Lower Gastrointestinal Bleeding Insohag University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper and Lower Gastrointestinal Bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cases
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endoscopy
Intervention Description
clinical and endoscopic pattern in patients with upper and lower gastrointestinal bleeding
Primary Outcome Measure Information:
Title
endoscopy in upper and lower gastrointestinal bleeding and percentage of each disorder
Description
detection of causes of gastrointestinal bleeding and percentage of each cause
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children under 18years old who present with upper and lower gastrointestinal bleeding
Exclusion Criteria:
bleeding due to systemic causes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya B Hussein, Resident
Phone
01018175090
Email
ayabakhet@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf M Radwan, Assistant professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical and Endoscopic Pattern in Children Presented With Upper and Lower Gastrointestinal Bleeding Insohag University Hospital
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