UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002873 |
|---|---|
| Receipt number | 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 22:55:07 |
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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
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
Sponsor or person
Institute
Department of Gastroenterological Surgery, Transplant and Surgical Oncology
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003509
