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Umblical Incision for Neonatal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03256669
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Gamal Abdelmalek, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neonatal Surgery Procedure: umbilical incision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umblical Incision for Neonatal Surgey; is it Suitable
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : April 1, 2018

Arm Intervention/treatment
Experimental: umbilical incision
neonates undergone surgery by umbilical incision
Procedure: umbilical incision
exploration through umbilical incision




Primary Outcome Measures :
  1. operative time [ Time Frame: 2 hours ]
    how long the peration does take


Secondary Outcome Measures :
  1. cosmotic appearance [ Time Frame: 2 weeks ]
    shape of the wound


Other Outcome Measures:
  1. result [ Time Frame: 1 week ]
    surgical result successful or not



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Ages Eligible for Study:   up to 20 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neonate diagnosed radiologically

Exclusion Criteria:

  • unclear diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256669


Locations
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Egypt
Assiut University
Asyut, Egypt, 71526
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Gamal Abdelmalek, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03256669    
Other Study ID Numbers: 1a765
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries