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
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
-
-
-
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
|
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
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.