UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031578 |
|---|---|
| Receipt number | R000036009 |
| Scientific Title | The incidence of cleft lip/palate before and after the Great East Japan Earthquake and Tsunami |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/06 09:40:00 |
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Basic information
Public title
The incidence of cleft lip/palate before and after the Great East Japan Earthquake and Tsunami
Acronym
Impact of the Great East Japan Earthquake on cleft incidence
Scientific Title
The incidence of cleft lip/palate before and after the Great East Japan Earthquake and Tsunami
Scientific Title:Acronym
Impact of the Great East Japan Earthquake on cleft incidence
Region
| Japan |
Condition
Condition
cleft lip/palate
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine whether the huge disaster such as the Great East Japan Earthquake and Tsunami affected the incidence of cleft lip/palate in a part of damaged area called Miyagi prefecture.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to determine whether the huge disaster such as the Great East Japan Earthquake and Tsunami affected the incidence of cleft lip/palate in a part of damaged area called Miyagi prefecture.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Considering that organogenic period was most sensitive to factors of circumstances, the affected period of birth was defined as during a year after 9 months of the disaster. The control period was setting as during 5 years before the affected period.
Main outcome measures were incidences of cleft lip/palate during the control period and the affected period by the Great East Japan Earthquake and Tsunami.
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
| 6 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Annual and monthly numbers of births with cleft lip/palate patient were obtained from the medical records of division of plastic surgery at Tohoku university hospital and Miyagi children's hospital. Considering that organogenic period was most sensitive to factors of circumstances, the affected period of birth was defined as during a year after 9 months of the disaster.
Key exclusion criteria
Those of births were not registered at Miyagi prefecture. Or those who were diagnosed as submucosal cleft palate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Imai |
Organization
Tohoku University Graduate School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi-pref., Japan
TEL
022-717-7332
yo-imai@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Imai |
Organization
Tohoku University Graduate School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi-pref., Japan
TEL
022-717-7332
Homepage URL
yo-imai@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Plastic and Reconstructive Surgery at Miyagi Children's hospital
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
| 2018 | Year | 04 | Month | 01 | 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: There were no significant differences between the control and affected periods in the prevalence (per 10,000 live births) of cleft lip with or without palate (13.8 versus 16.7; p=0.342), isolated cleft palate (5.2 versus 3.2; p=0.267), or overall cleft lip and/or cleft palate (19.0 versus 19.9; p=0.799).
Conclusions: We did not observe that the 2011 Tohoku earthquake and tsunami affected the birth prevalence of CL/P in Miyagi prefecture, even though it severely impacted human health in the area.
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
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Design: This was a retrospective cohort study.
Participants: The annual and monthly numbers of infants born with CL/P were obtained from medical records. The affected period of birth was defined as one year from December 1, 2011 to November 30, 2012. The control period was 5 years from January 1, 2006 to December 31, 2010. The annual and monthly numbers of births in Miyagi prefecture were obtained using e-Stat, which is a portal for Japanese government statistics.
Main outcome measures: Main outcome measures were birth prevalence of CL/P during the control and affected periods.
Management information
Registered date
| 2018 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036009
