Clinical and Endoscopic Pattern in Children Presented With Upper and Lower Gastrointestinal Bleeding Insohag University Hospital

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06047873

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Upper and Lower Gastrointestinal Bleeding	Device: Endoscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical and Endoscopic Pattern in Children Presented With Upper and Lower Gastrointestinal Bleeding Insohag University Hospital

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cases	Device: Endoscopy clinical and endoscopic pattern in patients with upper and lower gastrointestinal bleeding

Arm

Intervention/Treatment

Experimental: cases

Device: Endoscopy

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

Outcome Measures

Primary Outcome Measures

endoscopy in upper and lower gastrointestinal bleeding and percentage of each disorder [12 months]
detection of causes of gastrointestinal bleeding and percentage of each cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Weeks to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

bleeding due to systemic causes

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Bakhit Hussien, Resident-pediatric department-sohag hospital university, Sohag University

ClinicalTrials.gov Identifier:

NCT06047873

Other Study ID Numbers:

soh-Med-23-07-18MS

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Sep 21, 2023