Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430970
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-18
Brief Title:
Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia A Single Center Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Methods This is an open label prospective study conducted on one hundered twenty four patients with IDA who attended to the Endoscopy Unit Specialized Medical hospital Mansoura University Patients with active bleeding pregnant or lactating female contraindication of sedation uncontrolled diabetes mellitus uncontrolled thyroid disorders pregnancy respiratory embarrassment were excluded The study protocol was approved by our ethical committee and written consents were taken from all subjects before the procedure
Measures All patients underwent Complete blood count CBC with detection of specific hematological parameters Serum ferritin Iron and Total iron binding capacity INR serum albumin and bilirubin levels ALT Alanine Aminotransferase AST Aspartate aminotransferase ESR serum creatinine occult blood in stool FOBT kits small sample of stool collected in clean container usually taken on consecutive days with precaution before testing include stopping non-steroidal anti-inflammatory drugs vitamin C tablets raw vegetables and fruits and red meat often 48h to 72hour before test as they give false positive test 5 using immunochemical assay which detect globin chain of hemoglobin 6 All those proved with unexplained iron deficiency anemia were prepared to perform upper endoscopy and colonoscopy in later appointment
Procedures Esophgogastroduodenoscopy and colonscopy were performed in our endoscopy unit by the same endoscopist under conscious sedation Endoscopic examination was done by PENTAX medical EPK-I 5000 Tokyo Japan We usually started with colonscopic examintion Complete ileocolonscopy was done to all patients then esohgeogastroduoenoscopy any macroscopic lesion was detedcted documented and tissue biopsy was taken and sent for histopathological examination by the same pathologist
Measures All patients underwent Complete blood count CBC with detection of specific hematological parameters Serum ferritin Iron and Total iron binding capacity INR serum albumin and bilirubin levels ALT Alanine Aminotransferase AST Aspartate aminotransferase ESR serum creatinine occult blood in stool FOBT kits small sample of stool collected in clean container usually taken on consecutive days with precaution before testing include stopping non-steroidal anti-inflammatory drugs vitamin C tablets raw vegetables and fruits and red meat often 48h to 72hour before test as they give false positive test 5 using immunochemical assay which detect globin chain of hemoglobin 6 All those proved with unexplained iron deficiency anemia were prepared to perform upper endoscopy and colonoscopy in later appointment
Procedures Esophgogastroduodenoscopy and colonscopy were performed in our endoscopy unit by the same endoscopist under conscious sedation Endoscopic examination was done by PENTAX medical EPK-I 5000 Tokyo Japan We usually started with colonscopic examintion Complete ileocolonscopy was done to all patients then esohgeogastroduoenoscopy any macroscopic lesion was detedcted documented and tissue biopsy was taken and sent for histopathological examination by the same pathologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None