UMIN-CTR Clinical Trial

Basic information
Public title	Selection of sutures for wound infection prevention and cost reduction
Acronym	Selection of sutures for wound infection prevention and cost reduction
Scientific Title	Selection of sutures for wound infection prevention and cost reduction
Scientific Title:Acronym	Selection of sutures for wound infection prevention and cost reduction
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will compare and examine the incidence of wound infection due to changes in the abdominal wall suture, and also consider reducing medical costs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative wound infection incidence
Key secondary outcomes	Postoperative hospital stay, cost reduction effect, late complications

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing elective colorectal cancer surgery
Key exclusion criteria	Minors under the age of 20
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Masaji Middle name Last name Tani
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu-city, Shiga
TEL	0775-48-2238
Email	hqsurge1@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Terada
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu-city, Shiga
TEL	0775-48-2238
Homepage URL
Email	teradayo@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Seta Tsukinowa-cho, Otsu-city, Shiga
Tel	077-548-3576
Email	hqrec@belle.shiga-med.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	滋賀医科大学病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 02 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 10 Month 02 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Age, gender, BMI, underlying disease, tumor localization, clinical stage, preoperative test results (Hb, Alb, HbA1c, PNI) of patients who underwent elective colorectal cancer surgery at our hospital after January 2012, Surgical time, bleeding volume, postoperative complications, etc., to compare the incidence of wound infection before and after abdominal wall suture change, risk factors, preventive methods, and reduce medical costs consider.

Management information
Registered date	2021 Year 05 Month 06 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050386