Umblical Incision for Neonatal Surgery | NCT03256669

Studies
Umblical Incision for Neonatal Surgery

NCT03256669

Sponsor

Assiut University

Status

Completed

Last Update Posted

Apr 9, 2018Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Neonatal Surgery

Interventions

umbilical incision

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Apr 1, 2018Actual

First Submitted Date

Jul 29, 2017

First Submission Date that Met QC Criteria

Aug 20, 2017

First Posted Date

Aug 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2018

Last Update Posted Date

Apr 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
umbilical incision	Experimental	neonates undergone surgery by umbilical incision	Procedure: umbilical incision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
umbilical incision	Procedure	exploration through umbilical incision	umbilical incision

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neonate diagnosed radiologically

Exclusion Criteria:

unclear diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Hours

Maximum Age

20 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut		71526	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided