Intestinal ObstructionStomaPedNCT04213976
Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis
An observational study of Intestinal Obstruction and Gastroschisis, run by University Hospital, Angers at 5 sites in France.
Trial summary
Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the… Read more about this study
- Who is it for?
- Ages 1 minute to 16 years
- Conditions the study is for
- Intestinal Obstruction, Gastroschisis, Enterocolitis, Necrotizing
- What is being tested?
- Ileostomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Newborns and children presenting with complex intestinal obstruction and requiring the use of an ileostomy to discharge the upper intestine as part of surgical care.
Who may be able to join
- all patient aged 16 or less having had one or more ileostomy created as part of its care for an intestinal obstruction, between 2007/01/01 and 2019/08/31. If a patient requires more than one ileostomy, each new stoma will be analysed as a new entry in the study.
- patients having been operated in one of the paediatric surgical department participating in this study.
Who cannot join
- refusal or absence on consent of the patient and/or their legal representative to participate to the study.
- patient who had an ileostomy created in another center than the ones participating in the present study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital of Brest
Brest, 29200
Philine De Vries, MD, PhD, philine.devries@chu-brest.fr
University Hospital of Nantes
Nantes, 44000
Sébastien Faraj, MD, sebastien.faraj@chu-nantes.fr
Necker Enfants Malades Hospital
Paris, 75015
Sabine Sarnacki, MD, PhD, sabine.sarnacki@aphp.fr
University Hospital of Rennes
Rennes, 35200
Alexis Arnaud, MD, PhD, alexis.arnaud@chu-rennes.fr
University Hospital of Tours
Tours, 37000
Itissam Kassite, MD, ibtissam.kassite@univ-tours.fr
About this study
Official title: Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis
Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made.
The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population.
It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.
Read the detailed description
The methodology used will be a retrospective non interventional study of the cohorts of paediatric patients having had one or more ileostomies performed in one of the surgical centers participating in this study, between 2007, january the 1st and 2019, august the 31th.
The main outcome will be the duration (days) between full refunctionalization of the bowel in the groups of conventional ileostomy or ostomy in continuity, as assessed by the end of parenteral nutrition or the closure of the stoma.
Secondary outcomes will include (1) the number and type of complications directly related to the stoma and/or to intestinal complications; (2) the comparison of the results obtained by Santulli and Bishop-Koop ileostomies; (3) a sub-group analysis of the outcomes in the different underlying pathologies.
- Being tested
- Ileostomy
- Keywords
- ileostomy, enteral nutrition, complications of stoma
- Medical subject headings
- Intestinal Obstruction, Gastroschisis, Enterocolitis, Necrotizing, Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IleostomyProcedure or surgery
Also called Loop ileostomy, Santulli ileostomy, Bishop-Koop ileostomy
Use of an ileostomy to decompress the proximal bowel, perfored either as a conventional loop ileostomy or as described by Santulli et al. or by Bishop and Koop.
| Study group | Role | What they receive |
|---|---|---|
| Ileostomy in continuity | Paediatric patients having had an ileostomy in continuity as part of the treatment for a complex intestinal obstruction, as described by Santulli or by Bishop-Koop. Receives: Procedure: Ileostomy | |
| Conventional ileostomy | Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction. Receives: Procedure: Ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay before full refunctionalization of the small intestine
Mean delay before full enteral nutrition after the creation of the ileostomy, as assessed by either the end of the use of parenteral nutrition, or by closure of the ileostomy.
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Clinical description of the sub-groups of patients with ostomy in continuity
Clinical description of the patients (underlying disease, demographics, nutritional outcomes, medical and surgical complications) having had a Santulli or a Bishop-Koop ostomy.
Measured: through study completion, an average of 6 months
Comparative analysis of the complications of ostomies
Number and type of complications encountered after loop ileostomy and after ostomy in continuity
Measured: through study completion, an average of 6 months
Subgroup analysis of the patients according to their underlying pathology
Comparative analysis of the efficacy and complication rates of the different types of stoma in subgroups of patients, according to their underlying pathology
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal ObstructionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Françoise Schmitt, MD, PhD, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213976
- Sponsor's protocol ID
- 2019/10
- Acronym
- StomaPed
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
BISHOP HC, KOOP CE. Management of meconium ileus; resection, Roux-en-Y anastomosis and ileostomy irrigation with pancreatic enzymes. Ann Surg. 1957 Mar;145(3):410-4. doi: 10.1097/00000658-195703000-00017. No abstract available.
PubMed 13403593SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available.
PubMed 14497096Sehgal S, Sandler AD, Alfred Chahine A, Mohan P, Torres C. Ostomy in continuity: A novel approach for the management of children with complex short bowel syndrome. J Pediatr Surg. 2018 Oct;53(10):1989-1995. doi: 10.1016/j.jpedsurg.2018.02.059. Epub 2018 Mar 4.
PubMed 29602547
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis
- ClinicalTrials.gov ID
- NCT04213976
- Acronym / sponsor ID
- StomaPed / 2019/10
- Keywords
- ileostomy, enteral nutrition, complications of stoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Dec 2019 (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.
Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made.
The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population.
It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.
Detailed description
The methodology used will be a retrospective non interventional study of the cohorts of paediatric patients having had one or more ileostomies performed in one of the surgical centers participating in this study, between 2007, january the 1st and 2019, august the 31th.
The main outcome will be the duration (days) between full refunctionalization of the bowel in the groups of conventional ileostomy or ostomy in continuity, as assessed by the end of parenteral nutrition or the closure of the stoma.
Secondary outcomes will include (1) the number and type of complications directly related to the stoma and/or to intestinal complications; (2) the comparison of the results obtained by Santulli and Bishop-Koop ileostomies; (3) a sub-group analysis of the outcomes in the different underlying pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ileostomy in continuity | – | Procedure: IleostomyPaediatric patients having had an ileostomy in continuity as part of the treatment for a complex intestinal obstruction, as described by Santulli or by Bishop-Koop. |
| Conventional ileostomy | – | Procedure: IleostomyPaediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction. |
Who may qualify
- Ages
- 1 minute to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns and children presenting with complex intestinal obstruction and requiring the use of an ileostomy to discharge the upper intestine as part of surgical care.
Key inclusion criteria (2 listed)
- all patient aged 16 or less having had one or more ileostomy created as part of its care for an intestinal obstruction, between 2007/01/01 and 2019/08/31. If a patient requires more than one ileostomy, each new stoma will be analysed as a new entry in the study.
- patients having been operated in one of the paediatric surgical department participating in this study.
Key exclusion criteria (2 listed)
- refusal or absence on consent of the patient and/or their legal representative to participate to the study.
- patient who had an ileostomy created in another center than the ones participating in the present study.
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 |
|---|---|---|
| IleostomyAlso: Loop ileostomy, Santulli ileostomy, Bishop-Koop ileostomyUse of an ileostomy to decompress the proximal bowel, perfored either as a conventional loop ileostomy or as described by Santulli et al. or by Bishop and Koop. | Procedure or surgery | Conventional ileostomy, Ileostomy in continuity |
Primary outcome
Delay before full refunctionalization of the small intestine
Time frame: through study completion, an average of 6 months
Mean delay before full enteral nutrition after the creation of the ileostomy, as assessed by either the end of the use of parenteral nutrition, or by closure of the ileostomy.
3 secondary outcomes
Clinical description of the sub-groups of patients with ostomy in continuity
Time frame: through study completion, an average of 6 months
Comparative analysis of the complications of ostomies
Time frame: through study completion, an average of 6 months
Subgroup analysis of the patients according to their underlying pathology
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Results publication: PubMed 13403593BISHOP HC, KOOP CE. Management of meconium ileus; resection, Roux-en-Y anastomosis and ileostomy irrigation with pancreatic enzymes. Ann Surg. 1957 Mar;145(3):410-4. doi: 10.1097/00000658-195703000-00017. No abstract available.
- Results publication: PubMed 14497096SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available.
- Results publication: PubMed 29602547Sehgal S, Sandler AD, Alfred Chahine A, Mohan P, Torres C. Ostomy in continuity: A novel approach for the management of children with complex short bowel syndrome. J Pediatr Surg. 2018 Oct;53(10):1989-1995. doi: 10.1016/j.jpedsurg.2018.02.059. Epub 2018 Mar 4.
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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.
Françoise Schmitt, MD, PhD principal investigator
University Hospital of Angers
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Obstruction and Gastroschisis, run by University Hospital, Angers at 5 sites 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 2 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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Françoise Schmitt, MD, PhD (+33241354290, FrSchmitt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay before full refunctionalization of the small intestine (time frame: through study completion, an average of 6 months). 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 NCT04213976, which also lists 3 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 30 Dec 2019.