UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The incidence of cleft lip/palate before and after the Great East Japan Earthquake and Tsunami
Title of the study (Brief title)	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	Yoshimichi Imai
Organization	Tohoku University Graduate School of Medicine
Division name	Plastic and Reconstructive Surgery
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi-pref., Japan
TEL	022-717-7332
Email	yo-imai@med.tohoku.ac.jp

Public contact
Name of contact person	Yoshimichi Imai
Organization	Tohoku University Graduate School of Medicine
Division name	Plastic and Reconstructive Surgery
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi-pref., Japan
TEL	022-717-7332
Homepage URL
Email	yo-imai@med.tohoku.ac.jp

Sponsor
Institute	Department of Plastic and Reconstructive Surgery Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036009