NCT03256669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2017

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

July 29, 2017

Last Update Submit

April 5, 2018

Conditions

Neonatal Surgery

Outcome Measures

Primary Outcomes (1)

  • operative time

    how long the peration does take

    2 hours

Secondary Outcomes (1)

  • cosmotic appearance

    2 weeks

Other Outcomes (1)

  • result

    1 week

Study Arms (1)

umbilical incision

EXPERIMENTAL

neonates undergone surgery by umbilical incision

Procedure: umbilical incision

Interventions

umbilical incisionPROCEDURE

exploration through umbilical incision

umbilical incision

Eligibility Criteria

Age20 Hours - 20 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • neonate diagnosed radiologically

You may not qualify if:

  • unclear diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71526, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 29, 2017

First Posted

August 22, 2017

Study Start

January 1, 2017

Primary Completion

August 1, 2017

Study Completion

April 1, 2018

Last Updated

April 9, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)