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临床试验/NCT06430970
NCT06430970招募中不适用

Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia: A Single Center Prospective Study

Mansoura University2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
2
主要终点
diagnosis of the cause of anemia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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).

排除标准

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

结局指标

主要结局

diagnosis of the cause of anemia

时间窗: two years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Gameel

Dr

Mansoura University

研究点 (2)

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