UMIN-CTR Clinical Trial

Basic information
Public title	The incidence of surgical site infections after laparoscopic colorectal surgery using monofilament absorbable suture material
Acronym	The incidence of surgical site infections after laparoscopic colorectal surgery using monofilament absorbable suture material
Scientific Title	The incidence of surgical site infections after laparoscopic colorectal surgery using monofilament absorbable suture material
Scientific Title:Acronym	The incidence of surgical site infections after laparoscopic colorectal surgery using monofilament absorbable suture material
Region	Japan

Condition
Condition	colorectal malignant neoplasms
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verify the incidence of surgical site infections after laparoscopic colorectal surgery using monofilament absorbable suture material
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of surgical site infections after laparoscopic colorectal surgery using monofilament absorbable suture material within 30 days after surgery
Key secondary outcomes	The incidence of incisional hernia after laparoscopic colorectal surgery using monofilament absorbable suture material within 1 year after surgery

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	1) Patients who received laparoscopic colorectal surgery 2) Patients without active infectious diseases at receiving surgery 3) Patients over 20 year-old
Key exclusion criteria	1) Patients who could not be followed up for 30 days after surgery will be excluded at the time of statistical analysis 2) Patients who received stoma creation 3) Patients taking oral steroids as treatment for a chronic disease 4) Patients who receive hemodialysis 5) Patients who receive oxygen preoperatively for chronic lung disease 6) Patients who assessed unsuitable for participation in this study by their physicians
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Yamada
Organization	Nippon medical school
Division name	Department of Gastrointestinal and Hepato-Biliary-pancreatic surgery
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	y-tak@nms.ac.jp

Public contact
Name of contact person	1st name Hiromichi Middle name Last name Sonoda
Organization	Nippon medical school
Division name	Department of Gastrointestinal and Hepato-Biliary-pancreatic surgery
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	hiromichi-sonoda@nms.ac.jp

Sponsor
Institute	Nippon medical school
Institute
Department

Funding Source
Organization	Self funding
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	Ethical committee, Nippon medical school hospital
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel	03-3822-2131
Email	nms_fuzokurinri@nms.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	2021 Year 02 Month 25 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	Enrolling by invitation
Date of protocol fixation	2020 Year 07 Month 10 Day
Date of IRB	2020 Year 11 Month 13 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Verify the incidence of the surgical site infection after laparoscopic surgery within 30 days after surgery

Management information
Registered date	2021 Year 02 Month 25 Day
Last modified on	2021 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046903