UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002328 |
|---|---|
| Receipt number | 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 19:59:26 |
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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
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
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002848
