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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002142
Receipt No. R000002618
Scientific Title Prospective randomized controlled trial comparing continuous suture with interrupted suture for subcuticular closure after gastric cancer surgery
Date of disclosure of the study information 2009/07/01
Last modified on 2013/03/02

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Basic information
Public title Prospective randomized controlled trial comparing continuous suture with interrupted suture for subcuticular closure after gastric cancer surgery
Acronym Randomized trial of skin closure after gastric cancer surgery
Scientific Title Prospective randomized controlled trial comparing continuous suture with interrupted suture for subcuticular closure after gastric cancer surgery
Scientific Title:Acronym Randomized trial of skin closure after gastric cancer surgery
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate cosmetic results of continuous subcuticular suture and interrupted subcuticular suture after gastric cancer surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Cosmetic result
Key secondary outcomes cost, time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Continuous subcuticular suture
Interventions/Control_2 Interrupted subcuticular suture
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 gastric cancer
primary surgery
no metastasis
ASA PS 1-2
Key exclusion criteria uncontrolled diabetes
taking steroids
emergency surgery
Target sample size 210

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Inoue
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-3-1 shinmachi Hirakata city, 573-1191
TEL 072-804-0101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Inoue
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-3-1 shinmachi Hirakata city, 573-1191
TEL 072-804-0101
Homepage URL
Email inoueke@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 07 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 Completed
Date of protocol fixation
2009 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 30 Day
Last modified on
2013 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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