A Prospective Randomized Controlled Trial Comparing Primary Anastomosis and Bishop-Koop Procedure in the Management of Jejunoileal Atresia in Neonates, the Study Will be Done at Pediatric Surgery Unit, Elshatby Alexandria University Hospital in the Period From January 2026 Till January 2028.
A Prospective Randomized Controlled Trial Comparing Primary Anastomosis and Bishop-Koop Procedure in the Management of Jejunoileal Atresia in Neonates
randomized controlled trial comparing two techniques in treatment of neonatal jejuno-ileal atresia
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is prospective randomized controlled study parallel-group design, allocation ratio 1:1, stratification by: Jejunal vs ileal atresia,
Inclusion criteria:
- Neonates diagnosed intraoperatively with jejunal or ileal atresia
- Age ≤ 28 days
- Hemodynamically stable
- No gross bowel necrosis requiring extensive resection admitted to pediatric surgery unit, Elshatby Alexandria University hospital in the period from January 2026 till January 2028.
Exclusion criteria:
- Major life-limiting congenital anomalies
- Weight ≤ 2.5 kg
The patients included in the study will be categorized
-
Age
-
Sex
-
type of intestinal atresia
-
Technique done (primary anastomosis with\without tapering vs Bishop Koop)
-
Operative time
-
Post-operative period as regards:
- NGT aspirate
- Early post operative complications such as wound infection, leakage, sepsis
- Onset of feeding
- Bowel motion frequency
- Abdominal distension
- Upper contrast study before discharge
-
Hospital stay duration
-
Need for re-exploration
-
Mortality (30 days)
-
Follow-up visits 3-6 months post discharge.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Dr. Ahmed Maher Fathy Mohamed Khalil, lecturer of pediatric surgery
- Telefonnummer: +201128087844
- E-post: ahmed.maher@alexmed.edu.eg
Studiesteder
-
-
-
Alexandria, Egypt
- Rekruttering
- Alexandria University Faculty of Medicine
-
Ta kontakt med:
- Prof.Dr. jihan goefil, professor
- Telefonnummer: +2034851903
- E-post: vd_community@alexmed.edu.eg
-
Hovedetterforsker:
- Ahmed Maher Khalil, lecturer of pediatric surgery
-
Underetterforsker:
- mohamed abdelazim aboheba, professor of pediatric surgery
-
Underetterforsker:
- sameh mahmoud shehata, professor of pediatric surgery
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Neonates diagnosed intraoperatively with jejunal or ileal atresia
- Age ≤ 28 days
- Hemodynamically stable
- No gross bowel necrosis requiring extensive resection
Exclusion Criteria:
- Major life-limiting congenital anomalies
- Weight ≤ 2.5 kg
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: jejunal atresia
primary anastmosis or bishop koop |
primary anastomosis with\without tapering Bishop Koop technique |
|
Eksperimentell: ileal atresia
primary anastmosis vs bishop koop |
primary anastomosis with\without tapering Bishop Koop technique |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to full enteral feeding.
Tidsramme: 10 days
|
the time consumed post surgical repair to reach full oral feeding defined as ≥120 ml/kg/day tolerated without parenteral nutrition |
10 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
anastmotic leakage
Tidsramme: 5-7 days
|
leakage after performing anastmosis |
5-7 days
|
|
Mortality (30-day)
Tidsramme: 30 days
|
death of partitipant |
30 days
|
|
Need for re-exploration
Tidsramme: 7-10
|
Need for re-exploration |
7-10
|
|
Early postoperative sepsis
Tidsramme: 5-14 days
|
sepsis the develop in first week post surgery |
5-14 days
|
|
Duration of hospital stay
Tidsramme: 10-21
|
Duration of hospital stay |
10-21
|
|
Time to first bowel movement
Tidsramme: 3-10 days
|
the time consumed post surgery till neonate pass stool |
3-10 days
|
|
Time to remove nasogastric tube
Tidsramme: 3-7 days
|
the time pass post surgery till nasogastric tube removed |
3-7 days
|
|
Stoma-related complications (Bishop-Koop group)
Tidsramme: 5-90 days
|
the complication related to stoma that could occur in patients where bishop koop procedure was done |
5-90 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ahmed Maher Khalil, lecturer of pediatric surgery, Alexandria University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0307862
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
- Age
- Sex
- type of intestinal atresia
- Technique done (primary anastomosis with\without tapering vs Bishop Koop)
- Operative time
- Post-operative period
IPD-delingstidsramme
January 2026- January 2028
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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