UMIN-CTR Clinical Trial

Basic information
Public title	Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Acronym	Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Scientific Title	Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Scientific Title:Acronym	Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Region	Japan

Condition
Condition	Patients who will have surgery in general surgery department.
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and effectiveness of silicon made newly developed drain fixing device.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety (complication due to the use of newly developed drain fixing device, troubles with drain such as occlusion) Effectiveness (the pain caused by fixing the drain)
Key secondary outcomes

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	To evaluate safety and effectiveness of silicon made newly developed drain fixing device for the patients having surgery in general surgery department.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who are scheduled to have surgery in general surgery department. 2) Patients who will use 19Fr silicon drain for surgery. 3) Patients with over 20 years old, and below 90 years old. 4) PS 0 or 1. 5) Provided with written informed conscent.
Key exclusion criteria	1) Patients with infection or dermatitis on the drain insertion site. 2) Patients with mental disease who may have risk of self removal of the drain. 3) Patients with diabetes mellitus under insulin therapy, or under dialysis, or patients with immune deficiency. 4) Patients with severe obesity or emaciation. 5) Patients who doctor thinks inappropriate to participate in the study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Norihito Middle name Last name Wada
Organization	Keio University, School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	nori-kkr@umin.ac.jp

Public contact
Name of contact person	1st name Norihito Middle name Last name Wada
Organization	Keio University, School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	nori-kkr@umin.ac.jp

Sponsor
Institute	Keio University School of Medicine
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	Keio University School of Medicine, Ethics Committee
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.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	2014 Year 12 Month 05 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	Completed
Date of protocol fixation	2014 Year 07 Month 15 Day
Date of IRB	2013 Year 09 Month 27 Day
Anticipated trial start date	2014 Year 12 Month 05 Day
Last follow-up date	2015 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	2014 Year 12 Month 04 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018441