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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
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Upper and Lower Gastrointestinal Bleeding

Eligibility Criteria

2 Weeks - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 14, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Sohag University
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    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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