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Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05470946
Recruitment Status : Not yet recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Information provided by (Responsible Party):
Maiada Mohie Eldin Ibrahim, Assiut University

Brief Summary:
To identify the role of enteroscopy in diagnosis and treatment of small intestinal diseases.

Condition or disease Intervention/treatment Phase
Small Intestine Disease Device: Double balloon enteroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Arm Intervention/treatment
Double balloon enteroscopy
Device: Double balloon enteroscopy
Double balloon enteroscopy (EN-580T, Fujifilm, Japan)

Primary Outcome Measures :
  1. Diagnostic role of enteroscopy in small intestinal diseases [ Time Frame: 2 years ]
    To assess frequency of benign and malignant lesions of small intestine by histopathpathological examination of the obtained biopsy

Secondary Outcome Measures :
  1. Side effects and complications of enteroscopy [ Time Frame: 2 years ]
    To report the rate of any side effects and/or complications of the procedure such as perforation and to report rate of incomplete enteroscopy and its causes

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • • All patients will undergo gastroscopy, colonoscopy, abdominal computed tomography and/or magnetic resonance imaging, or radionuclide examination without a clear diagnosis will be subjected to enteroscopy including:

    • patients with obscure digestive tract bleeding
    • patients with obscure diarrhea
    • patients with obscure abdominal pain
    • patients with obscure weight loss
    • patients with obscure intestinal obstruction • Patients with imaging suggesting small intestinal lesions

Exclusion Criteria:

  • Patients who aren't eligible for anesthesia e.g.: severe cardiovascular, respiratory dysfunction or coagulopathy.
  • Patients who aren't eligible for endoscopy e.g.: fulminant colitis, acute perforation and peritonitis, and impending perforation, intestinal obstruction, recent intestinal surgery.
  • Patient's refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05470946

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Contact: Maiada Ibrahim 01068388643 maiada145@yahoo.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Maiada Mohie Eldin Ibrahim, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT05470946    
Other Study ID Numbers: Diagnostic role of enteroscopy
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases