HypospadiaNCT01483313
Intelligence Changes Following Minor Surgery
An observational study of Hypospadia and Phimosis, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadia, Phimosis, Inguinal Hernia
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- Men only
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Any congenital central nervous system diseases
- Any congenital heart diseases
- Any congenital dysgnosia
- Birth weight less than 2kg
- Ever been hypoxic encephalopathy when birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intelligence Performance in Adolescence After Early Exposure to Anesthesia and Minor Surgery
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
- Medical subject headings
- Hypospadias, Phimosis, Hernia, Inguinal
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Intelligence Scale for Children
Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery.
Measured: Average 5 years after surgery
Secondary outcomes (1)
Achenbach Child Behavior Checklist
Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery.
Measured: Average 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: No patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
- Investigators
- Diansan Su, M.D., Ph.D, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483313
- Sponsor's protocol ID
- RenJiH-20111005
- Status last verified
- Mar 2012
- First submitted
- 13 Oct 2011
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligence Performance in Adolescence After Early Exposure to Anesthesia and Minor Surgery
- ClinicalTrials.gov ID
- NCT01483313
- Acronym / sponsor ID
- RenJiH-20111005
- Conditions
- Hypospadia, Phimosis, Inguinal Hernia
- Keywords
- Anesthestics, Minor surgery, Wechsler Intelligence Scale for Children, Cognitiion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Any congenital central nervous system diseases
- Any congenital heart diseases
- Any congenital dysgnosia
- Birth weight less than 2kg
- Ever been hypoxic encephalopathy when birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Achenbach Child Behavior Checklist
Time frame: Average 5 years after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diansan Su, M.D., Ph.D principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypospadia and Phimosis, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Intelligence Scale for Children (time frame: Average 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.