Intelligence Changes Following Minor Surgery

NCT01483313 | Withdrawn DMC

• 1 other identifier: RenJiH-20111005
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypospadia; Phimosis; Inguinal Hernia

Keywords

Anesthestics; Minor surgery; Wechsler Intelligence Scale for Children; Cognitiion

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Achenbach Child Behavior Checklist

  Average 5 years after surgery

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Children's Medical Center: collaborator

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Hypospadias; Phimosis; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Diansan Su, M.D., Ph.D

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 11, 2014

Record last verified: 2012-03

Locations

CN (1)