UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002108 |
|---|---|
| Receipt number | R000002572 |
| Scientific Title | Prospective randomized controlled trial comparing continuous suture with interrupted suture for primary dermis closure methods after colorectal cancer surgery. |
| Date of disclosure of the study information | 2009/06/23 |
| Last modified on | 2016/10/06 20:41:04 |
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Basic information
Public title
Prospective randomized controlled trial comparing continuous suture with interrupted suture for primary dermis closure methods after colorectal cancer surgery.
Acronym
Prospective randomized controlled trial comparing continuous suture with interrupted suture for primary dermis closure methods after colorectal cancer surgery.
Scientific Title
Prospective randomized controlled trial comparing continuous suture with interrupted suture for primary dermis closure methods after colorectal cancer surgery.
Scientific Title:Acronym
Prospective randomized controlled trial comparing continuous suture with interrupted suture for primary dermis closure methods after colorectal cancer surgery.
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate cosmetic value of primary dermis closure method comparing continuous suture with interrupted suture after colorectal cancer surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
After six months of operation, we take a picture of wound scar and measure the size of wound scar blindly. This picture evaluated visual scale by three surgeons and three nurses.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
This study aimed to evaluate cosmetic value of primary dermis closure method comparing continuous suture with interrupted suture after colorectal cancer surgery.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary colorectal cancer patients over twenty years old.
No evidence of metastasis patients.
Procedure of operation is unnecessary.
Patients that agree this study on document of informed consent.
Key exclusion criteria
Severe controlled diabetes patient and patients taken steroids.
Patients that required emergency operation for perforation or bleeding of intestine.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuji Tokuhara |
Organization
Kansai Medical University Hirakata Hospital
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuji Tokuhara |
Organization
Kansai Medical University Hirakata Hospital
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata
TEL
072-804-0101
Homepage URL
tokuhark@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 06 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002572
