Intelligence Changes Following Minor Surgery

This study has been withdrawn prior to enrollment.

(No patients enrolled.)

Sponsor:

Collaborator:

Shanghai Children's Medical Center

Information provided by (Responsible Party):

diansan su, RenJi Hospital

ClinicalTrials.gov Identifier:

NCT01483313

First received: October 13, 2011

Last updated: February 9, 2014

Last verified: March 2012

History of Changes

Purpose

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.

Condition
Hypospadia Phimosis Inguinal Hernia


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Intelligence Performance in Adolescence After Early Exposure to Anesthesia and Minor Surgery

Further study details as provided by diansan su, RenJi Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	0
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	6 Years to 16 Years (Child)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

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.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483313

Locations


China
Renji Hospital
Shanghai, China, 200127

Sponsors and Collaborators

RenJi Hospital

Shanghai Children's Medical Center

Investigators


Principal Investigator:	Diansan Su, M.D., Ph.D	RenJi Hospital

More Information


Responsible Party:	diansan su, Principal Investigator, RenJi Hospital
ClinicalTrials.gov Identifier:	NCT01483313 History of Changes
Other Study ID Numbers:	RenJiH-20111005
Study First Received:	October 13, 2011
Last Updated:	February 9, 2014

Keywords provided by diansan su, RenJi Hospital:


Anesthestics Minor surgery Wechsler Intelligence Scale for Children Cognitiion

Additional relevant MeSH terms:


Hernia, Inguinal Hypospadias Phimosis Hernia, Abdominal Hernia	Pathological Conditions, Anatomical Penile Diseases Genital Diseases, Male Urogenital Abnormalities Congenital Abnormalities

ClinicalTrials.gov processed this record on July 14, 2017

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