UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027081 |
|---|---|
| Receipt number | R000031041 |
| Scientific Title | Surgical site infection after emergency surgery for perforation peritonitis : a prospective multicenter observational study |
| Date of disclosure of the study information | 2017/04/22 |
| Last modified on | 2021/12/16 15:03:45 |
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Basic information
Public title
Surgical site infection after emergency surgery for perforation peritonitis : a prospective multicenter observational study
Acronym
Surgical site infection after emergency surgery for perforation peritonitis : a prospective multicenter observational study
Scientific Title
Surgical site infection after emergency surgery for perforation peritonitis : a prospective multicenter observational study
Scientific Title:Acronym
Surgical site infection after emergency surgery for perforation peritonitis : a prospective multicenter observational study
Region
| Japan |
Condition
Condition
Perforation peritonitis
Classification by specialty
| Gastrointestinal surgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to reveal the relationship between intraoperative procedure of emergency surgery for peritonitis due to gastrointestinal perforation and deep or organ-space surgical site infection.
Basic objectives2
Others
Basic objectives -Others
Clarification of risk factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Deep incisional or organ/space SSI (CDC guideline)
Key secondary outcomes
Hospital stay
30-day postoperative death
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
Patient who underwent emergency surgery for perforation peritonitis after visiting emergency department.
Key exclusion criteria
Perforated appendicitis
Hospital onset
Iatrogenic perforation
Esophageal perforation
Penetration of intestine
Temporary abdominal closure
Ineligibility for this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Okishio |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
811-1 Kimiidera, Wakayama 641-8509, Japan
TEL
073-441-0603
okishio@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Okishio |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
811-1 Kimiidera, Wakayama 641-8509, Japan
TEL
073-441-0603
Homepage URL
okishio@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2017 | Year | 04 | Month | 22 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following data are collected.
1) Preoperative data: gender, age, height, weight, BMI, smoking habit, diabetes mellitus, use of hemodialysis, use of steroid, past history of laparotomy, thickness of subcutaneous fat, ASA physical status classification, blood culture, serum albumin concentration, estimated perforation-operation time interval, arrival-operation time interval
2) Operative findings: perforated site, ascites culture, contaminated site, operation time, intraoperative blood loss, use of transfusion, lowest body temperature
3) Surgical techniques: surgical site preparation, use of wound protector devices, intra-abdominal lavage and changing of gloves, incisional irrigation and changing of gloves, fascial sutures, skin closure, sites and number of intra-abdominal drains, use of subcutaneous drain, changing of surgical instruments, stoma creation
4) Duration of postoperative antibiotic treatment
5) Postoperative findings: APACHEII score in ICU, the highest blood glucose level in 3 days
6) Deep incisional or organ/space SSI
7) Length of hospital stay
8) 30-day postoperative death
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031041
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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