Stoma ColostomySTOMPNCT06458699
Management Of Stoma In Patients Younger Than 3 Months Old
An observational study of Stoma Colostomy and Stoma Ileostomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also acquired conditions, such as enterocolitis or intestinal perforation. Read more about this study
- Who is it for?
- Ages 1 minute to 3 months
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy, Neonatal Disease
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2024to 15 Jul 2024
- 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 minute to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates whose disease require a stoma during the first 3 months of life, from January 2009 to December 2023
Who may be able to join
- Patients who had a stoma during the first 3 months of life, from January 2009 to December 2023
Who cannot join
- Patients who had a stoma after the first 3 months of life, from January 2009 to December 2023
- Patients without a stoma
Trial locations and contacts
1 site in 1 country.
France1 site
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63000
About this study
Official title: Management of Ostomy in Neonates: A Retrospective Single-Center Study
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also acquired conditions, such as enterocolitis or intestinal perforation. The aim of these stomas is to divert stool in the event of intestinal obstruction or risk of fecal contamination.
Depending on the indication and the type of stoma used, the post-operative follow-up, such as resumption of intestinal transit and feeding, secondary closure of the stoma or not, and the duration and cost of hospitalization differ.
The aim of this study is to compare these differences in order to extract an optimal management strategy, in the light of what is reported in the international scientific literature.
Read the detailed description
The investigators gathered the data of patients born between January 2009 and December 2023, who had an ostomy made during the first three months of their life.
The investigators then analyzed the patients outcomes ( postoperative complications, length of stay, cost of hospitalization) depending on the etiology of their primary disease.
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Neonatal Disease
- Keywords
- Ostomy, Neonate, Outcomes, Costs
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hirschsprung's Disease | Patients with Hirschsprung's Disease who had a stoma in the first 3 months of life | |
| Anorectal MAlformations | Patients with Anorectal MAlformations who had a stoma in the first 3 months of life | |
| Intestinal Atresia | Patients with Intestinal Atresia who had a stoma in the first 3 months of life | |
| Necrotizing Enterocolitis | Patients with Necrotizing Enterocolitis who had a stoma in the first 3 months of life | |
| Intestinal Perforations | Patients with Intestinal Perforations who had a stoma in the first 3 months of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative medical complications
infections, sepsis, dehydration, hydroelectrolytic disorders
Measured: through study completion, an average of 1 year
Postoperative surgical complications
disunion, surgical scar,
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Length of stay
time of hospitalization
Measured: through study completion, an average of 1 year
Hospitalization costs
costs by department and overall costs
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start30 May 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle Destinval, MD, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458699
- Sponsor's protocol ID
- 2024-CF-265
- Acronym
- STOMP
- Status last verified
- Apr 2024
- First submitted
- 5 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Ostomy in Neonates: A Retrospective Single-Center Study
- ClinicalTrials.gov ID
- NCT06458699
- Acronym / sponsor ID
- STOMP / 2024-CF-265
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Neonatal Disease
- Keywords
- Ostomy, Neonate, Outcomes, Costs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also acquired conditions, such as enterocolitis or intestinal perforation. The aim of these stomas is to divert stool in the event of intestinal obstruction or risk of fecal contamination.
Depending on the indication and the type of stoma used, the post-operative follow-up, such as resumption of intestinal transit and feeding, secondary closure of the stoma or not, and the duration and cost of hospitalization differ.
The aim of this study is to compare these differences in order to extract an optimal management strategy, in the light of what is reported in the international scientific literature.
Detailed description
The investigators gathered the data of patients born between January 2009 and December 2023, who had an ostomy made during the first three months of their life.
The investigators then analyzed the patients outcomes ( postoperative complications, length of stay, cost of hospitalization) depending on the etiology of their primary disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hirschsprung's Disease | – | –Patients with Hirschsprung's Disease who had a stoma in the first 3 months of life |
| Anorectal MAlformations | – | –Patients with Anorectal MAlformations who had a stoma in the first 3 months of life |
| Intestinal Atresia | – | –Patients with Intestinal Atresia who had a stoma in the first 3 months of life |
| Necrotizing Enterocolitis | – | –Patients with Necrotizing Enterocolitis who had a stoma in the first 3 months of life |
| Intestinal Perforations | – | –Patients with Intestinal Perforations who had a stoma in the first 3 months of life |
Who may qualify
- Ages
- 1 minute to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates whose disease require a stoma during the first 3 months of life, from January 2009 to December 2023
Key inclusion criteria (1 listed)
- Patients who had a stoma during the first 3 months of life, from January 2009 to December 2023
Key exclusion criteria (2 listed)
- Patients who had a stoma after the first 3 months of life, from January 2009 to December 2023
- Patients without a stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative medical complications
Time frame: through study completion, an average of 1 year
infections, sepsis, dehydration, hydroelectrolytic disorders
Postoperative surgical complications
Time frame: through study completion, an average of 1 year
disunion, surgical scar,
2 secondary outcomes
Length of stay
Time frame: through study completion, an average of 1 year
Hospitalization costs
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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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.
Christelle Destinval, MD study director
University Hospital, Clermont-Ferrand
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 Stoma Colostomy and Stoma Ileostomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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 France. 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?
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?
Postoperative medical complications (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.