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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03346876
Date of registration: 15/11/2017
Prospective Registration: No
Primary sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Public title: Autonomic Dysfunction in Patients With Pectus Excavatum. ADPE
Scientific title: Autonomic Dysfunction in Patients With Pectus Excavatum.
Date of first enrolment: August 1, 2017
Target sample size: 120
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03346876
Study type:  Observational [Patient Registry]
Study design:   
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Mei-Chen Yang, MD
Address: 
Telephone: +886-66289779
Email: mimimai3461@gmail.com
Affiliation: 
Name:     Mei-Chen Yang, MD
Address: 
Telephone: +886-66289779
Email: mimimai3461@gmail.com
Affiliation: 
Name:     Mei-Chen Yang, MD
Address: 
Telephone:
Email:
Affiliation:  Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Clinical diagnosis of pectus excavatum

2. Agree to receive Nuss surgery to correct pectus excavatum

Exclusion criteria:

1. Major medical disease (asthma, heart failure, renal disease)

2. Known psychiatric disease

3. Known sleep-disordered breathing

4. Skeletal disease

5. Major surgery within 6 months



Age minimum: 13 Years
Age maximum: 45 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pectus Excavatum
Surgery
Autonomic Dysfunction
Intervention(s)
Procedure: Nuss surgery
Primary Outcome(s)
The impact of Nuss surgery on HRV in patients with pectus excavatum [Time Frame: 6 months]
Secondary Outcome(s)
Secondary ID(s)
TCRD-TPE-106-RT-2
05-XD-57-110
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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