UMIN-CTR Clinical Trial

Basic information
Public title	The study of the improvement of postoperative gastrointestinal motility by visual stimulation
Acronym	The study of the improvement of postoperative gastrointestinal motility by visual stimulation
Scientific Title	The study of the improvement of postoperative gastrointestinal motility by visual stimulation
Scientific Title:Acronym	The study of the improvement of postoperative gastrointestinal motility by visual stimulation
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the improvement of postoperative gastrointestinal motility by visual stimulation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of postoperative ileus
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Group viewing meal images on iPad after surgery
Interventions/Control_2	Control
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	18 years of age or older who have undergone laparoscopic colorectal resection at our hospital
Key exclusion criteria	Those who lack the capacity to give consent Those who have undergone reoperation for recurrence of colorectal cancer Those with stoma Those with inflammatory bowel disease as the primary disease Those who are judged by the principal investigator or subinvestigators to be inappropriate to participate in this study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Norikatsu Middle name Last name Miyoshi
Organization	Osaka university, Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	E2, 2-2, Yamadaoka, Suita-shi, Osaka
TEL	06-6879-3251
Email	nmiyoshi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Rie Middle name Last name Hayashi
Organization	Osaka university, Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	E2, 2-2, Yamadaoka, Suita-shi, Osaka
TEL	06-6879-3251
Homepage URL
Email	rhayashi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka university, Graduate School of Medicine Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization	None
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	Osaka University Hospital Ethics Review Committee
Address	2-2, Yamadaoka, Suita-shi, Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-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 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 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 06 Month 23 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2024 Year 09 Month 30 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 07 Month 29 Day
Last modified on	2022 Year 07 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054066