UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004723 |
|---|---|
| Receipt number | R000005627 |
| Scientific Title | A prospective cohort study focusing on the incisional wound complications following the abdominal surgery, multicenter trial |
| Date of disclosure of the study information | 2010/12/24 |
| Last modified on | 2018/12/20 10:35:04 |
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Basic information
Public title
A prospective cohort study focusing on the incisional wound complications following the abdominal surgery, multicenter trial
Acronym
NSIS-1
Scientific Title
A prospective cohort study focusing on the incisional wound complications following the abdominal surgery, multicenter trial
Scientific Title:Acronym
NSIS-1
Region
| Japan |
Condition
Condition
Digestive surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency and risk factors of the incision wound complication in the abdominal surgery
Basic objectives2
Others
Basic objectives -Others
objective study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incisional wound complication (incisional hernia, wound dehiscence, surgical site infection)
Key secondary outcomes
Medical economic effect (postoperative length of stay)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Digestive surgery
Key exclusion criteria
complete lararoscopic surgery (except laparoscopic-assisted surgery)
Patients who was diagnosed as not adequate for this trial
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduated School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yokoyama |
Organization
Nagoya University Graduated School of Medicine
Division name
Division of Surgical Infection
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
Homepage URL
Sponsor or person
Institute
Division of Surgical Infection
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduated School of Medicine
Organization
Division
Category of Funding 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
| 2010 | Year | 12 | Month | 24 | 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
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
| 2010 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients included in this study will be followed up for 6 months after abdominal surgery to evaluate if they have any surgical wound related complications (incisional hernia, wound dehiscence, and surgical site infection).
Management information
Registered date
| 2010 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005627
