UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective cohort study focusing on the incisional wound complications following the abdominal surgery, multicenter trial
Title of the study (Brief title)	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	Masato Nagino
Organization	Nagoya University Graduated School of Medicine
Division name	Division of Surgical Oncology
Address	65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL	052-744-2222
Email

Public contact
Name of contact person	Yukihiro Yokoyama
Organization	Nagoya University Graduated School of Medicine
Division name	Division of Surgical Infection
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005627