UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027081
Receipt No. 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 2017/04/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 clarify risk factors for surgical site infection (SSI) after emergency surgery for perforation peritonitis; furthermore, to find risk factors that can be controlled.
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
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
Email 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
Email okishio@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 22 Day
Last follow-up date
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, 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, 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, peritoneum sutures, fascial sutures, skin sutures, sites and number of intra-abdominal drains, use of subcutaneous drain, changing of surgical instruments, stoma creation
4) Preoperative and postoperative antibiotics
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
2017 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.