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Full Thickness vs. Rectal Suction Biopsy in the Diagnosis of Hirschsprungs Disease

NCT05307419 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-05-17

No results posted yet for this study

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 (HD) in children. The secondary objective to compare cost-effectiveness of the two procedures

Conditions

  • Hirschsprung Disease

Interventions

PROCEDURE

Rectal suction biopsy.

Suction biopsy performed

PROCEDURE

Full-thickness rectal biopsy.

Full-thickness biopsy performed

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Mark mr Ellebaek, Dr · University of Southern Denmark

  • Rasmus mr Nielsen, Dr · Odense University Hospital

  • Gunvor ms Madsen, Dr · Odense University Hospital

  • Niels mr Bjorn, Dr · Odense University Hospital

  • Lene ms Christensen, Dr · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-01-01
Completion
2024-02-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307419 on ClinicalTrials.gov