UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Acronym	Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Scientific Title	Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Scientific Title:Acronym	Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Region	Japan

Condition
Condition	colon disease
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Introduce a DVD about the stoma to patients and their families before stoma enlargement, and conduct an interview survey after watching the DVD before discharge from the hospital. Aimed at finding help
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in accepted body image for stoma
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	after admission
Interventions/Control_2	before discharge
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	Stoma expansion patient
Key exclusion criteria	Patients with additional stomas in emergency surgery
Target sample size	5

Research contact person
Name of lead principal investigator	1st name miho Middle name Last name Kawasaki
Organization	Yamagata University Hospital
Division name	Yamagata University Hospital 9F East Ward
Zip code	999-9585
Address	2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL	023-633-1122
Email	yu-ikekenkyu@jm.kj.yamagata-u.ac.jp

Public contact
Name of contact person	1st name mariko Middle name Last name takeda
Organization	Yamagata University Hospital
Division name	Yamagata University Hospital 9F East Ward
Zip code	99990-9585
Address	2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL	023-633-1122
Homepage URL
Email	marikoope@gmail.com

Sponsor
Institute	Yamagata University
Institute
Department

Funding Source
Organization	Yamagata University Hospital
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	Yamagata University School of Medicine Ethics Review Committee
Address	2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
Tel	023-628-5047
Email	mailto:yu-ikekenkyu@jm.kj.yamagata-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 10 Month 30 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 27 Day
Last follow-up date	2023 Year 12 Month 31 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 10 Month 28 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056140