UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An observational study to evaluate the relasionship between swalloing function and swalloing pressure in a Patient after recontractive operation of Oral cancer
Title of the study (Brief title)	The study of swalloing pressure after recontractive operation of Oral cancer
Region	Japan

Condition
Condition	oral cacer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluation the relationship between swalloing function and swalloing pressure after reconstractive operation for oral cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The relationship between Swalloing function and Swalloing pressure
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a patient after oral canser surgery with reconstraction
Key exclusion criteria	patents judged inappropriate for this study by the physicians
Target sample size	25

Research contact person
Name of lead principal investigator	Nibu Ken-ichi
Organization	Kobe University Graduate School of Medicine
Division name	Department of otorhinolarngology Head and Neck surgery
Address	7-5-1,Kusunoki-cho,Chuo-uku,Kobe,Hyougo,650-0017,Japan
TEL	81-78-382-5111
Email	nibu@med.kobe-u.ac.jp

Public contact
Name of contact person	Nibu Ken-ichi
Organization	Kobe University Graduate School of Medicine
Division name	Department of otorhinolarngology Head and Neck surgery
Address	7-5-1,Kusunoki-cho,Chuo-uku,Kobe,Hyougo,650-0017,Japan
TEL	81-78-382-5111
Homepage URL	http://www.hosp.kobe-u.ac.jp/chiken/OOchiken_top.htm
Email	nibu@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine Department of otorhinolarngology Head and Neck surgery
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine Department of otorhinolarngology Head and Neck surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2017 Year 11 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	the observational study

Management information
Registered date	2017 Year 10 Month 04 Day
Last modified on	2017 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032649