UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015042 |
|---|---|
| Receipt number | R000017501 |
| Scientific Title | Modification of the Nuss procedure: The single incision technique |
| Date of disclosure of the study information | 2014/09/03 |
| Last modified on | 2014/09/03 16:34:39 |
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Basic information
Public title
Modification of the Nuss procedure: The single incision technique
Acronym
Modification of the Nuss procedure
Scientific Title
Modification of the Nuss procedure: The single incision technique
Scientific Title:Acronym
Modification of the Nuss procedure
Region
| Japan |
Condition
Condition
Pectus excavatum
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The standard Nuss procedure uses at least three skin incisions to insert several instruments. We research retrospectively the safety and efficacy of our seven cases underwent a modified Nuss procedure using a single incision.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety is judged by the presence of complications. The efficacy is evaluated by Pre- and post-operative Haller index using computed tomography.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with the single-incision Nuss procedure for pectus excavatum
Key exclusion criteria
Those who dropped out of follow up
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsushi Aizawa |
Organization
National Defense Medical Collage
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
04-2995-1211
nagareyamatsudo@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsushi Aizawa |
Organization
National Defense Medical Collage
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
04-2995-1211
Homepage URL
nagareyamatsudo@live.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, National Defense Medical Collage
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2014 | Year | 09 | Month | 03 | Day |
Last modified on
| 2014 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017501
