Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt

June 22, 2023 updated by: Sarah Magdy Abdelmohsen, Aswan University Hospital
Kasai portoenterostomy is the key standard operation for biliary atresia. The aim of the study is to evaluate the short-term outcome of Kasai portoenterostomy for biliary atresia infants in Upper Egypt.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is a cross-sectional retrospective multicenter study from Upper Egypt. The data will collected from the medical records of three university hospitals in Upper Egypt from January 2019 to December 2019.

Inclusion and exclusion criteria

Inclusion criteria included all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy.

Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

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

Study Locations

  • Egypt
    • Aswan Governorate
      • Aswan, Aswan Governorate, Egypt, 11331
        • Aswan University Hospital

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

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

all neonates diagnosed with biliary atresia in the previous period (2019) and managed by Kasai portoenterostomy.

Description

Inclusion Criteria:

  • all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy.

Exclusion Criteria:

  • Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all neonates diagnosed with biliary atresia and managed by Kasai portoenterostomy.
all neonates diagnosed with biliary atresia in the previous period 2019 and managed by Kasai portoenterostomy.
Procedure: Kasai portoenterostomy operation.
Kasai portoenterostomy operation for biliary atresia patients.
Other Names:
  • Kasai operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of jaundice clearance
Time Frame: from 3 months up to one year
the clearance of jaundice measured by total serum bilirubin < 1.2 mg \ dL and direct bilirubin < 0.3 mg dL within one year postoperatively
from 3 months up to one year

Collaborators and Investigators

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

Sponsor

Aswan University Hospital

Investigators

  • Principal Investigator: Sarah Abdelmohsen, Md, Aswan University Hospital

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)

January 1, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aswan UH7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It was a cross-sectional retrospective multicenter study from Upper Egypt. The data will collect from the medical records of three university hospitals in Upper Egypt from January 2019 to December 2019.

IPD Sharing Time Frame

January 2019- December 2019

IPD Sharing Access Criteria

Biliary Atresia in Upper Egypt

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

product manufactured in and exported from the U.S.

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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