Intelligence Changes Following Minor Surgery

Inguinal Hernia Clinical Trial

Official title:

Intelligence Performance in Adolescence After Early Exposure to Anesthesia and Minor Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01483313
• Other study ID #: RenJiH-20111005
• Status: Withdrawn
• Phase: N/A
• First received: October 13, 2011
• Last updated: February 9, 2014
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Years to 16 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia, Inguinal
• Hypospadia
• Hypospadias
• Inguinal Hernia
• Phimosis

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No