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 UMIN000004723
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Division of Surgical Infection
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.