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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002873
Receipt No. R000003509
Scientific Title A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers
Date of disclosure of the study information 2009/12/10
Last modified on 2009/12/10

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Basic information
Public title A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers
Acronym A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers
Scientific Title A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers
Scientific Title:Acronym A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers
Region
Japan

Condition
Condition Esophageal disease, Gastric disease, Colon disease
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Degree of wound pain
Key secondary outcomes Occurrence rate of SSI

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 considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 suture with synthetic absorbable sutures or skinstaplers
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient of Esophagseal disease, Gastric disease, or Colon disease
Key exclusion criteria a extra-resional dissection
b emergency
c laparoscopic operation
d pneumonia, peritonisis, ileus, perforation or intraabdominal infection
e bleeding, disorder of wound healing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Naomoto
Organization Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery, Transplant and Surgical Oncology
Zip code
Address 2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL 086-235-7255
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery, Transplant and Surgical Oncology
Zip code
Address
TEL 086-235-7255
Homepage URL
Email

Sponsor
Institute Department of Gastroenterological Surgery, Transplant and Surgical Oncology
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
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
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 12 Month 10 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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 10 Day
Last modified on
2009 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003509

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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