UMIN-CTR Clinical Trial

Basic information
Public title	The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Acronym	The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Scientific Title	The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Scientific Title:Acronym	The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Region	Japan

Condition
Condition	Inguinal hernia
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarifying the effectiveness of supplemental explanatory videos in preoperative informed consent
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient satisfaction and understanding Questionnaire survey after preoperative informed consent
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Watch an explanatory video before operation
Interventions/Control_2	No video
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	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Inguinal hernia preoperative First surgery Understandable
Key exclusion criteria	Emergency surgery Visual / hearing impairment Perform other surgery at the same time
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Nakashima
Organization	Kyoto University
Division name	Pharmacoepidemiology
Zip code	6068501
Address	Yoshidakonoecyo Sakyoku Kyoto
TEL	075-753-9469
Email	nakashima.masayuki.4p@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Masayuki Middle name Last name Nakashima
Organization	Kyoto University
Division name	Pharmacoepidemiology
Zip code	6068501
Address	Yoshidakonoecyo Sakyoku Kyoto
TEL	075-753-9469
Homepage URL
Email	nakashima.masayuki.4p@kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Pharmacoepidemiology
Institute
Department

Funding Source
Organization	Kyoto University Pharmacoepidemiology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University
Address	Yoshidakonoecyo Sakyoku Kyoto
Tel	075-753-9469
Email	nakashima.masayuki.4p@kyoto-u.ac.jp

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	2022 Year 01 Month 31 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	Enrolling by invitation
Date of protocol fixation	2021 Year 05 Month 24 Day
Date of IRB	2021 Year 05 Month 24 Day
Anticipated trial start date	2021 Year 05 Month 24 Day
Last follow-up date	2022 Year 05 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 31 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053347