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RecruitingNCT07925814Updated Nov 9, 2026

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.

An interventional study of primary anastmosis and bishop koop in Atresia, Intestinal, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2026, registered Nov 2026).
  • Started May 2026; still recruiting 6 months later.
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
Up to 28 Days
Sex
All
01

Study summary

randomized controlled trial comparing two techniques in treatment of neonatal jejuno-ileal atresia

Read the detailed description

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.
02

Conditions studied

  • Atresia, Intestinal

Keywords

  • intestinal atresia, jejunoileal atresia, neonatal intestinal obstruction
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neonates diagnosed intraoperatively with jejunal or ileal atresia
  • Age ≤ 28 days
  • Hemodynamically stable
  • No gross bowel necrosis requiring extensive resection

Exclusion criteria

Exclusion Criteria:

  • Major life-limiting congenital anomalies
  • Weight ≤ 2.5 kg
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    jejunal atresia

    primary anastmosis or bishop koop

    Procedure: primary anastmosis · Procedure: bishop koop

  • Experimental
    ileal atresia

    primary anastmosis vs bishop koop

    Procedure: primary anastmosis · Procedure: bishop koop

Interventions

  • Procedureprimary anastmosis

    primary anastomosis with\\without tapering

  • Procedurebishop koop

    Bishop Koop technique

06

What researchers measure

Primary outcomes

  1. Time to full enteral feeding.

    the time consumed post surgical repair to reach full oral feeding defined as ≥120 ml/kg/day tolerated without parenteral nutrition

    Time frame: 10 days

Secondary outcomes

  1. anastmotic leakage

    leakage after performing anastmosis

    Time frame: 5-7 days

  2. Mortality (30-day)

    death of partitipant

    Time frame: 30 days

  3. Need for re-exploration

    Need for re-exploration

    Time frame: 7-10

  4. Early postoperative sepsis

    sepsis the develop in first week post surgery

    Time frame: 5-14 days

  5. Duration of hospital stay

    Duration of hospital stay

    Time frame: 10-21

  6. Time to first bowel movement

    the time consumed post surgery till neonate pass stool

    Time frame: 3-10 days

  7. Time to remove nasogastric tube

    the time pass post surgery till nasogastric tube removed

    Time frame: 3-7 days

  8. Stoma-related complications (Bishop-Koop group)

    the complication related to stoma that could occur in patients where bishop koop procedure was done

    Time frame: 5-90 days

07

Study locations

1 of 1 sites recruiting
  • Alexandria University Faculty of Medicine
    Alexandria, Egypt
    Recruiting
    • Prof.Dr. jihan goefil, professor · Contactvd_community@alexmed.edu.eg · +2034851903
    • Ahmed Maher Khalil, lecturer of pediatric surgery · Principal investigator
    • mohamed abdelazim aboheba, professor of pediatric surgery · Sub investigator
    • sameh mahmoud shehata, professor of pediatric surgery · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — Age Sex type of intestinal atresia Technique done (primary anastomosis with\without tapering vs Bishop Koop) Operative time Post-operative period

Supporting information: Study protocol

Time frame: January 2026- January 2028

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for Jan 2028, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 9, 2026
StartActual
May 1, 2026
Primary completionEst.
Jan 1, 2028
CompletionEst.
May 30, 2028
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925814
Responsible party
Ahmed Maher (Dr. Ahmed Maher, Alexandria University) — Principal investigator
First posted
Nov 9, 2026
Start date
May 1, 2026
Primary completion
Jan 1, 2028 (estimated)
Completion
May 30, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

Dr. Ahmed Maher Fathy Mohamed Khalil, lecturer of pediatric surgery
Contact
ahmed.maher@alexmed.edu.eg
+201128087844
Ahmed Maher Khalil, lecturer of pediatric surgery
principal investigator · Alexandria University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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