Intelligence Changes Following Minor Surgery | NCT01483313

Studies
Intelligence Changes Following Minor Surgery

NCT01483313

Sponsor

RenJi Hospital

Status

Withdrawn

Last Update Posted

Feb 11, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Hypospadia
Phimosis
Inguinal Hernia

Interventions

Not provided

Countries

China

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled.

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Oct 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Oct 13, 2011

First Submission Date that Met QC Criteria

Nov 29, 2011

First Posted Date

Dec 1, 2011Estimated

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

Feb 9, 2014

Last Update Posted Date

Feb 11, 2014Estimated

Name	Class
Shanghai Children's Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Animal studies showed that many general anesthetics might result in neuron apoptosis and neurocognitive impairment in the developing brain. However results from human studies are conflicted. In present study, the investigators examined the association between early exposure to anesthesia and surgery for minor surgery and intelligence changes in adolescence using the Wechsler Intelligence Scale for Children.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wechsler Intelligence Scale for Children	Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery.	Average 5 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Achenbach Child Behavior Checklist	Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery.	Average 5 years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Born from 1995
Male
Parents or guardian agree to attend this study
Undergone minor surgery (Repair of hypospadias, phimosiectomy, cryptorchidectomy or cryptorchidopexy and repair of inguinal hernia)
Children who scarify the No.1 to No.3 but no experience of any surgery.
Those who undergone minor surgery in Renji Hospital 4-6years ago.

Exclusion Criteria:

Any congenital central nervous system diseases
Any congenital heart diseases
Any congenital dysgnosia
Birth weight less than 2kg
Ever been hypoxic encephalopathy when birth

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

The investigators would like chose the Children who undergone minor surgery in Renji hospital 4-6years ago and their friends who never had any surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diansan Su, M.D., Ph.D	RenJi Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital		Shanghai		200127	China

Condition Browse Module

MeSH Terms

ID	Term
D007021	Hypospadias
D010688	Phimosis
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided