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CompletedNCT03256669Updated Apr 9, 2018

Umblical Incision for Neonatal Surgery

An interventional study of umbilical incision in Neonatal Surgery, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 20 Hours to 20 Days. Per ClinicalTrials.gov, last updated 2018-04-09.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
20 Hours to 20 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neonatal Surgery
03

Who can participate

Ages eligible
20 Hours to 20 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • neonate diagnosed radiologically

Exclusion criteria

Exclusion Criteria:

  • unclear diagnosis
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    umbilical incision

    neonates undergone surgery by umbilical incision

    Procedure: umbilical incision

Interventions

  • Procedureumbilical incision

    exploration through umbilical incision

05

What researchers measure

Primary outcomes

  1. operative time

    how long the peration does take

    Time frame: 2 hours

Secondary outcomes

  1. cosmotic appearance

    shape of the wound

    Time frame: 2 weeks

Other outcomes

  1. result

    surgical result successful or not

    Time frame: 1 week

06

Study locations

1 site
  • Assiut University
    Asyut, 71526, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03256669
Lead sponsor
Assiut University
Responsible party
Ahmed Gamal Abdelmalek (assistant lecturer, Assiut University) — Principal investigator
First posted
Aug 22, 2017
Start date
Jan 1, 2017
Primary completion
Aug 1, 2017
Completion
Apr 1, 2018
Last update
Apr 9, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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