UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036670 |
|---|---|
| Receipt number | R000041785 |
| Scientific Title | A randomized analysis for subcuticular sutures versus staples for skin closure after liver resection |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2020/11/07 12:49:38 |
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Basic information
Public title
A randomized analysis for subcuticular sutures versus staples for skin closure after liver resection
Acronym
Methods for skin closure after liver resection
Scientific Title
A randomized analysis for subcuticular sutures versus staples for skin closure after liver resection
Scientific Title:Acronym
RCT for skin closure after liver resection
Region
| Japan |
Condition
Condition
Require for liver resection
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Subcuticular sutures is known as a prefer for infectious complication after surgery. We planned to assess the infection rate between subcuticular sutures and staples for skin closure after liver resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infectious complication of the surgical wound.
Key secondary outcomes
total infection rate, terms of administration and total medical cost
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Subcuticular sutures
Interventions/Control_2
staples for 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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Require liver resection
2) entire treatment case
3) no other other resection but for gull bladder
4) EGOG PS 0-2
5) No co-morbidity for operation
6) Enough liver functional reserve
7) more than 20Y
Key exclusion criteria
1) No other abdominal surgery within 1 month.
2) No OMI or unstable angina within 6 month.
3) No idiopathic pneumonia or severe fibrosis of lung
4) Allergic reaction for operation materials
5) Stable psychologic status
6) Under pregnancy
7) Emergency operation
8) judged as "no inclusion" by the treatment doctors
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | SHINTARO |
| Middle name | |
| Last name | YAMAZAKI |
Organization
Nihon university school of medicine
Division name
Digestive surgery
Zip code
1738610
Address
30-1 Ohyaguchkamicho Itabashiku Tokyo Japan
TEL
0339728111
yamazaki-nmed@umin.ac.jp
Public contact
Name of contact person
| 1st name | SHINTARO |
| Middle name | |
| Last name | YAMAZAKI |
Organization
Nihon university school of medicine
Division name
Digestive surgery
Zip code
1738610
Address
30-1 Ohyaguchkamicho Itabashiku Tokyo Japan
TEL
0339728111
Homepage URL
yamazaki-nmed@umin.ac.jp
Sponsor or person
Institute
Nihon university school of medicine
Institute
Department
Personal name
Funding Source
Organization
No funding in this study
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
Nihon university school of medicine
Address
30-1 Ohyaguchkamicho Itabashiku Tokyo Japan
Tel
0339728111
yamazaki-nmed@umin.ac.jp
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
| 2019 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
none
Publication of results
Partially published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
560
Results
As the primary outcome, the wound complication rate did not differ significantly. As the secondary endpoint the wound complication rate in repeat resection significantly less frequent in subcuticular suture.
Results date posted
| 2020 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
common liver resection without biliary reconstruction.
Participant flow
Of the 581 enrolled patients, 281 patients with subcuticular sutures and 283 patients with staples were analysed.
Adverse events
None
Outcome measures
Primary: total wound complication.
Secondary: wound complication in repeat resection.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2020 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041785
