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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002328
Receipt No. R000002848
Scientific Title A comparison of prevention for abdominal wall hernia closing between monofilament and braided-filament closure.
Date of disclosure of the study information 2009/08/12
Last modified on 2013/03/22

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Basic information
Public title A comparison of prevention for abdominal wall hernia closing between monofilament and braided-filament closure.
Acronym Prevention of hernia after miline abdominal incision
Scientific Title A comparison of prevention for abdominal wall hernia closing between monofilament and braided-filament closure.
Scientific Title:Acronym Prevention of hernia after miline abdominal incision
Region
Japan

Condition
Condition gastric cancer, colo-rectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find a better surgical technique and material for closing abdominal incision
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of abdominal hernia after midline incision.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 interrupted suturing with 1 PDS II (Polydioxanone) monofilament suture
Interventions/Control_2 interrupted suturing with 1 POLYSORB (glycolide/lactile copolymer) braided suter
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 open gastrectomy, colectomy and anterior rectal resection.
Key exclusion criteria Not curative operarion
Re-operation
Laparoscopic surgery
Under immuno-suppression
Patients who was diagnosed as not adequate for this trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University Graduate School of Medicine
Division name Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chuouku, Chiba
TEL 043-226-2110
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kawahira
Organization Chiba University Graduate School of Medicine
Division name Frontier Surgery
Zip code
Address
TEL 043-226-2110
Homepage URL
Email

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Scholarship donation
Organization
Division
Category of Funding Organization Profit organization
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 08 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2011 Year 12 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 08 Month 12 Day
Last modified on
2013 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002848

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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