Umblical Incision for Neonatal Surgery

April 5, 2018 updated by: Ahmed Gamal Abdelmalek, Assiut University

Umblical Incision for Neonatal Surgey; is it Suitable

Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can solve the problem to some extent by making a smaller scar but takes more time and need special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy and avoid the drawbacks of both.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

six cases were subjected to the study 2 cases have duodenal atresia, one case has annular pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of malrotation. all of them had made exploration by the umbilical incision, and no drains had been used.

Study Type

Interventional

Enrollment (Actual)

7

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 Locations

  • Egypt
      • Asyut, Egypt, 71526
        • Assiut University

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

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • neonate diagnosed radiologically

Exclusion Criteria:

  • unclear diagnosis

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: umbilical incision
neonates undergone surgery by umbilical incision
Procedure: umbilical incision
exploration through umbilical incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 2 hours
how long the peration does take
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cosmotic appearance
Time Frame: 2 weeks
shape of the wound
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
result
Time Frame: 1 week
surgical result successful or not
1 week

Collaborators and Investigators

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

Sponsor

Assiut 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)

January 1, 2017

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

July 29, 2017

First Submitted That Met QC Criteria

August 20, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1a765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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