UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043439 |
|---|---|
| Receipt number | R000046903 |
| Scientific Title | The incidence of surgical site infections after laparoscopic colorectal surgery using monofilament absorbable suture material |
| Date of disclosure of the study information | 2021/02/25 |
| Last modified on | 2021/02/25 19:00:56 |
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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
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
hiromichi-sonoda@nms.ac.jp
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
