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.

November 4, 2026 updated by: Ahmed Maher, Alexandria University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Ahmed Maher Fathy Mohamed Khalil, lecturer of pediatric surgery
  • Phone Number: +201128087844
  • Email: ahmed.maher@alexmed.edu.eg

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria University Faculty of Medicine
        • Contact:
        • Principal Investigator:
          • Ahmed Maher Khalil, lecturer of pediatric surgery
        • Sub-Investigator:
          • mohamed abdelazim aboheba, professor of pediatric surgery
        • Sub-Investigator:
          • sameh mahmoud shehata, professor of pediatric surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: jejunal atresia

primary anastmosis or bishop koop
Procedure: primary anastmosis

primary anastomosis with\without tapering

Procedure: bishop koop

Bishop Koop technique
Experimental: ileal atresia

primary anastmosis vs bishop koop
Procedure: primary anastmosis

primary anastomosis with\without tapering

Procedure: bishop koop

Bishop Koop technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to full enteral feeding.
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anastmotic leakage
Time Frame: 5-7 days

leakage after performing anastmosis
5-7 days
Mortality (30-day)
Time Frame: 30 days

death of partitipant
30 days
Need for re-exploration
Time Frame: 7-10

Need for re-exploration
7-10
Early postoperative sepsis
Time Frame: 5-14 days

sepsis the develop in first week post surgery
5-14 days
Duration of hospital stay
Time Frame: 10-21

Duration of hospital stay
10-21
Time to first bowel movement
Time Frame: 3-10 days

the time consumed post surgery till neonate pass stool
3-10 days
Time to remove nasogastric tube
Time Frame: 3-7 days

the time pass post surgery till nasogastric tube removed
3-7 days
Stoma-related complications (Bishop-Koop group)
Time Frame: 5-90 days

the complication related to stoma that could occur in patients where bishop koop procedure was done
5-90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Ahmed Maher Khalil, lecturer of pediatric surgery, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0307862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  • Age
  • Sex
  • type of intestinal atresia
  • Technique done (primary anastomosis with\without tapering vs Bishop Koop)
  • Operative time
  • Post-operative period

IPD Sharing Time Frame

January 2026- January 2028

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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