Status:
UNKNOWN
Full Thickness vs. Rectal Suction Biopsy in the Diagnosis of Hirschsprungs Disease
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
Odense University Hospital
Conditions:
Hirschsprung Disease
Eligibility:
All Genders
Up to 15 years
Phase:
NA
Brief Summary
The objective of this prospective study is to compare the diagnostic accuracy of rectal suction biopsy (RSB) compared to full thickness rectal biopsy (FTB) in the diagnosis of Hirschsprungs Disease (H...
Detailed Description
Diagnostic procedures involving the need of surgically obtaining tissue material, carry the risk of complications and the risk of being inconclusive due to various reasons. Lowering the risk of inconc...
Eligibility Criteria
Inclusion
- Patients that are referred for rectal biopsy for suspected HD, age 0-15 years.
- Written informed consent of the parents or guardian.
Exclusion
- Lack of consent from parents or guardians.
- Previous surgery on the ano-rectum e.g. crohns disease and/or fistulas
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05307419
Start Date
January 1 2022
End Date
February 1 2024
Last Update
May 17 2022
Active Locations (1)
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1
Odense University Hospital
Odense, Fyn, Denmark, 5000