UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002480
Receipt No. R000002406
Scientific Title A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications
Date of disclosure of the study information 2009/09/15
Last modified on 2016/02/10

* 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 A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications
Acronym A randomized controlled trial to reducing wound complications
Scientific Title A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications
Scientific Title:Acronym A randomized controlled trial to reducing wound complications
Region
Japan

Condition
Condition Surgery for gastrointestinal diseases
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effect of dermal skin closure on reducing wound complication compared to staple skin closure in gastrointestinal surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Occurrence of wound complications
Key secondary outcomes Occurrence of keloid formation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 stapling skin-closure
Interventions/Control_2 dermal skin-closure
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 1) gastrointestinal surgery
2)
4,000/mm3=<WBC=<12,000 /mm3
Hb>=9.0 g/dL
Plt>=100,000 / mm3
T.Bil=<1.5 mg/dL
AST=<100 IU/L
ALT=<100 IU/L
Creatinin=<1.2 mg/dL
Albumin>=2.8 g/dL
3) written informed consent.
Key exclusion criteria 1) emergency
2) laparoscopic surgery
3) re-laparotomy
4) severe infections
5) bleeding tendency or coagulation disorders
6) uncontrolled diabetes mellitus
7) phsychic disorder
8) severe heart or lung diseases
9) continuous use of steroids
Target sample size 1060

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimasa Tsujinaka
Organization Osaka National Hospital
Division name Surgery
Zip code
Address 2-1-14, Hoenzaka, Osaka City, Osaka , JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University
Division name Gastroentrological Surgery
Zip code
Address
TEL 06-6879-3251
Homepage URL
Email

Sponsor
Institute Multicenter Clinical Study Group of Osaka
Institute
Department

Funding Source
Organization Multicenter Clinical Study Group of Osaka
Organization
Division
Category of Funding Organization Non profit foundation
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 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Lancet. 2013 Sep 28;382(9898):1105-12.
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 Main results already published
Date of protocol fixation
2009 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 11 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002406

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.