NCT05038345

Brief Summary

Hirschsprung disease (HD) is associated with significant morbidities including long-term bowel dysfunction. The aim of this study was to update national and regional trends in the epidemiology and inpatient care utilization of HD in the United States between 2009 and 2014 using the National Inpatient Sample (NIS).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,787

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2.4 years

First QC Date

August 31, 2021

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study was to analyze cost of HD-related admissions in the United States between 2009 and 2014 using the National Inpatient Sample (NIS) database.

    2009 to 2014.

Interventions

The principal purpose of pull through surgery for Hirschsprung disease is to remove aganglionic bowel and reconstruct the intestinal tract by connecting the normally innervated bowel just above the anus so that normal sphincter function is preserved.

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

We included all patients who were 18 years or younger with an ICD-9-CM code of 751.3 for HD among the first 10 diagnosis. Patients whose discharge disposition was transfer to another hospital were excluded to avoid over-counting. We identified patients with a pull-through procedure using following ICD-9-CM codes: 4592, 4593, 4594, 4595, 4840, 4841, 4842, 4843, 4849, and 4865. We tracked the number of these pull-through procedures a patient received. We used all 15 procedure codes to identify pull-through procedures and other procedures. To identify common discharge diagnoses we used the first five diagnosis codes. To identify congenital anomalies we used all diagnosis codes.

You may qualify if:

  • We included all patients who were 18 years or younger with an ICD-9-CM code of 751.3 for HD among the first 10 diagnosis.

You may not qualify if:

  • Data from 2015 to 2018 were not included since diagnoses and procedures were reported using the ICD-10-CM coding system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (2)

  • Huang EY, Tolley EA, Blakely ML, Langham MR. Changes in hospital utilization and management of Hirschsprung disease: analysis using the kids' inpatient database. Ann Surg. 2013 Feb;257(2):371-5. doi: 10.1097/SLA.0b013e31827ee976.

    PMID: 23263193BACKGROUND
  • Dharmaraj R, Reno J, Fridge J, Perger L, Zhu Y. Inpatient Care Utilization and Epidemiology of Hirschsprung Disease: Analysis of the National Inpatient Sample. J Pediatr Gastroenterol Nutr. 2022 Jul 1;75(1):3-9. doi: 10.1097/MPG.0000000000003449. Epub 2022 May 27.

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesMegacolonColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yiliang Zhu

    University of New Mexico

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Assistant Professor

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 9, 2021

Study Start

March 13, 2019

Primary Completion

August 15, 2021

Study Completion

August 15, 2021

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations