NCT06430970

Brief Summary

Background In practice, however, not all anaemic patients undergo appropriate diagnostic tests for the detection of iron deficiency anemia (IDA), and a significant portion of patients with IDA do not receive endoscopic evaluations. Accordingly, this study aimed to detect the prevalence of significant endoscopic (upper and lower endoscopy) and pathological findings in patients presenting with unexplained iron deficiency anaemia. Methods One hundred twenty-four patients with confirmed IDA with no obvious cause who visited the Internal Medicine Clinic were randomly selected. Patients with active bleeding, pregnant or lactating females, or those with contraindications to sedation were excluded. Upper and lower endoscopy were held in the endoscopy unit of Specialized Medical Hospital and tissue biopsy from significant endoscopic findings was sent for histopathological examination.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 18, 2024

Last Update Submit

May 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • diagnosis of the cause of anemia

    two years

Study Arms (1)

patients with iron deficiency anemia

OTHER
Device: endoscopy

Interventions

endoscopyDEVICE

upper and lower endoscopy

patients with iron deficiency anemia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sex: both
  • Age: from 18 to 70 years
  • Cases confirmed iron deciency anemia with no obvious cause.
  • Significant UGI pathology includes Barrett's esophagus, esophagitis (LA class ≥ C), esophagogastric varices, peptic ulcer disease, duodenal ulcer, angioectasia , and cancer (Wuerth BA and Rockey DC,2018).
  • Significant LGI pathology includes adenomatous polyps \>1cm, angioectasias, rectal ulcer, IBS , colon polyps and cancer. ( Ghassemi KA and Jensen DM,2013).

You may not qualify if:

  • Patients with active bleeding, pregnant or lactating female, contraindication of sedation (uncontrolled diabetes mellitus, uncontrolled thyroid disorders, pregnancy, respiratory embarrassment) were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakhlia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

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
Dr

Study Record Dates

First Submitted

May 18, 2024

First Posted

May 28, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations