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NCT04213976: StomaPed
Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis
trial testing Ileostomy in Intestinal Obstruction in 300 participants. Status unknown.
30 June 2020
Quick facts
| Lead sponsor | University Hospital, Angers |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 January 2020 |
| Primary completion | 30 June 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 5 locations across France |
Drugs / interventions tested
- Ileostomy
Conditions studied
- Intestinal Obstruction — all drugs for Intestinal Obstruction →
- Gastroschisis — all drugs for Gastroschisis →
- Enterocolitis, Necrotizing — all drugs for Enterocolitis, Necrotizing →
- Hirschsprung Disease — all drugs for Hirschsprung Disease →
Sponsor
University Hospital, Angers
Who can join
Adults 1 Minute to 16, any sex, with Intestinal Obstruction or Gastroschisis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04213976
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other University Hospital, Angers trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04213976 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Angers
- Last refreshed: 30 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04213976.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing