UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002108
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email tokuhark@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University Hirakata Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002572

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.