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Intelligence Changes Following Minor Surgery

This study is currently recruiting participants.
Verified March 2012 by RenJi Hospital
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: March 7, 2012
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

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by RenJi Hospital:

Primary Outcome Measures:
  • Wechsler Intelligence Scale for Children [ Time Frame: Average 5 years after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery.


Estimated Enrollment: 800
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
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483313

Contacts
Contact: Diansan Su, M.D., Ph.D. 0086-1381-7294-179 Diansansu@yahoo.com

Locations
China
Renji Hospital Recruiting
Shanghai, China, 200127
Contact: Diansan Su, M.D., Ph.D.     0086-1381-7294-179     diansansu@yahoo.com    
Principal Investigator: Diansan Su, M.D., Ph.D            
Sponsors and Collaborators
RenJi Hospital
Shanghai Children's Medical Center
Investigators
Principal Investigator: Diansan Su, M.D., Ph.D RenJi Hospital
  More Information

No publications provided

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: March 7, 2012
Health Authority: China: Ethics Committee

Keywords provided by RenJi Hospital:
Anesthestics
Minor surgery
Wechsler Intelligence Scale for Children
Cognitiion

Additional relevant MeSH terms:
Urethral Diseases
Hernia
Hernia, Inguinal
Phimosis
Hypospadias
Epispadias
Pathological Conditions, Anatomical
 Hernia, Abdominal
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013