UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003005
Receipt No. R000003641
Scientific Title Clinical trial on efficacy of subcuticuar suture using absorbable suture threads in colorectal surgery
Date of disclosure of the study information 2010/01/09
Last modified on 2012/08/09

* 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 Clinical trial on efficacy of subcuticuar suture using absorbable suture threads in colorectal surgery
Acronym Clinical trial on efficacy of subcuticuar suture using absorbable suture threads in colorectal surgery
Scientific Title Clinical trial on efficacy of subcuticuar suture using absorbable suture threads in colorectal surgery
Scientific Title:Acronym Clinical trial on efficacy of subcuticuar suture using absorbable suture threads in colorectal surgery
Region
Japan

Condition
Condition colorectal disease
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Developement of a new standard method of cutaneous closure in colorectal surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes surgical site infection
condition of the wound after surgery
Key secondary outcomes patients' satisfaction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Standard therapy group (interrupted sutures using nylon thread)
Interventions/Control_2 Trial therapy group (interrupted subcuticular sutures using PDS thread)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria patients who underwent elective colorectal surgery
Key exclusion criteria emergency surgery
patients with acute inflammation
patients who have to undergo concurrent resection of the other organs
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sotaro Sadahiro
Organization Tokai University
Division name Department of Gastrointestinal Surgery
Zip code
Address 143 Shimokasuya Isehara, Kanagawa, 259-1193, Japan
TEL 0463-93-1121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sotaro Sadahiro
Organization Tokai University
Division name Department of Gastrointestinal Surgery
Zip code
Address 143 Shimokasuya Isehara, Kanagawa, 259-1193, Japan
TEL 0463-93-1121
Homepage URL
Email sadahiro@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University, Department of Gastrointestinal Surgery
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 東海大学病院 (神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 09 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
2007 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 09 Day
Last modified on
2012 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003641

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.