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Intelligence Changes Following Minor Surgery

This study has been withdrawn prior to enrollment.
(No patients enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483313
First Posted: December 1, 2011
Last Update Posted: February 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shanghai Children's Medical Center
Information provided by (Responsible Party):
diansan su, RenJi Hospital
  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

Information from the National Library of Medicine

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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:

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

Exclusion Criteria:

  1. Any congenital central nervous system diseases
  2. Any congenital heart diseases
  3. Any congenital dysgnosia
  4. Birth weight less than 2kg
  5. Ever been hypoxic encephalopathy when birth
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 13, 2011
First Posted: December 1, 2011
Last Update Posted: February 11, 2014
Last Verified: March 2012

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