Hirschsprung DiseaseNCT05038345
Hirschsprung Disease Trends in the United States: Analysis of the National Inpatient Sample
An observational study of Hirschsprung Disease, run by University of New Mexico at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- Pull through surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,787 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 15 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Data from 2015 to 2018 were not included since diagnoses and procedures were reported using the ICD-10-CM coding system.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: Inpatient Care Utilization and Epidemiology of Hirschsprung Disease in the United States: Analysis of the National Inpatient Sample
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).
Read the detailed description
Hirschsprung disease (HD) is a congenital condition characterized by the absence of ganglion cells in the myenteric and submucosal plexuses of the distal intestine, which results in lack of peristalsis and functional intestinal obstruction. The aganglionosis involves the rectum or rectosigmoid in most cases, but it can extend for varying lengths, and in 5-10% of cases can involve the entire colon or even a significant amount of the small intestine. The incidence of this disease is approximately 1 in 5000 live births and is approximately three times more common in males. HD is a multifactorial disease caused by both genetic and environmental factors, and HD may also be part of a syndrome, most commonly Trisomy 21.
The principal purpose of surgical management of HD 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. Over the last decades, surgical management has changed from original three-stage approach to recent introduction of minimally invasive one-stage procedures, which appears to be safe, and facilitates early feeding and discharge. Although surgical treatment definitively removes the histologically defined pathological intestinal segment, many patients with HD continue to experience bowel dysfunction, obstructive symptoms and recurrent enterocolitis requiring frequent hospitalizations.
Huang et al had shown that HD discharges, associated demographics, and numbers of pull-through procedures remained stable from 1997 to 2006. There is a paucity in the literature regarding cost components associated with care of hospitalized patients with the primary diagnosis of HD. An information update regarding inpatient care utilization for HD is needed to better understand current HD disease burden and inpatient care practice. 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. Secondary objectives were to update national and regional trends in the epidemiology of HD related hospital utilization, and to examine changing demographics, hospital mortality and length of hospital stay (LOS) in these HD patients.
- Conditions
- Hirschsprung Disease
- Being tested
- Pull through surgery
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pull through surgeryProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2009 to 2014.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start13 Mar 2019
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Why it stopped: Per PI, the study was terminated prematurely since the data collection was completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,787 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajmohan Dharmaraj, University of New Mexico
- Investigators
- Yiliang Zhu, Study director, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038345
- Sponsor's protocol ID
- 18-697
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23263193Dharmaraj 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.
PubMed 35622006
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Care Utilization and Epidemiology of Hirschsprung Disease in the United States: Analysis of the National Inpatient Sample
- ClinicalTrials.gov ID
- NCT05038345
- Acronym / sponsor ID
- 18-697
- Conditions
- Hirschsprung Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Per PI, the study was terminated prematurely since the data collection was completed
- Enrolment
- 2,787 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Hirschsprung disease (HD) is a congenital condition characterized by the absence of ganglion cells in the myenteric and submucosal plexuses of the distal intestine, which results in lack of peristalsis and functional intestinal obstruction. The aganglionosis involves the rectum or rectosigmoid in most cases, but it can extend for varying lengths, and in 5-10% of cases can involve the entire colon or even a significant amount of the small intestine. The incidence of this disease is approximately 1 in 5000 live births and is approximately three times more common in males. HD is a multifactorial disease caused by both genetic and environmental factors, and HD may also be part of a syndrome, most commonly Trisomy 21.
The principal purpose of surgical management of HD 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. Over the last decades, surgical management has changed from original three-stage approach to recent introduction of minimally invasive one-stage procedures, which appears to be safe, and facilitates early feeding and discharge. Although surgical treatment definitively removes the histologically defined pathological intestinal segment, many patients with HD continue to experience bowel dysfunction, obstructive symptoms and recurrent enterocolitis requiring frequent hospitalizations.
Huang et al had shown that HD discharges, associated demographics, and numbers of pull-through procedures remained stable from 1997 to 2006. There is a paucity in the literature regarding cost components associated with care of hospitalized patients with the primary diagnosis of HD. An information update regarding inpatient care utilization for HD is needed to better understand current HD disease burden and inpatient care practice. 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. Secondary objectives were to update national and regional trends in the epidemiology of HD related hospital utilization, and to examine changing demographics, hospital mortality and length of hospital stay (LOS) in these HD patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Data from 2015 to 2018 were not included since diagnoses and procedures were reported using the ICD-10-CM coding system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pull through surgeryThe 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. | Procedure or surgery | – |
Primary outcome
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.
Time frame: 2009 to 2014.
Results and safety
The study was stopped early (reason given: Per PI, the study was terminated prematurely since the data collection was completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 23263193Huang 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.
- Derived from this study: PubMed 35622006Dharmaraj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiliang Zhu study director
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirschsprung Disease, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Per PI, the study was terminated prematurely since the data collection was completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2009 to 2014.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038345, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.