UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	predictor of postoperative mechanical ventilation over 48 hours in patient with intestinal perforation
Title of the study (Brief title)	predictor of postoperative mechanical ventilation in patient with intestinal perforation
Region	Japan

Condition
Condition	intestinal perforation
Classification by specialty	Surgery in general Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intestinal perforation often require emergency operation. The disease have high morbidity and mortality, and require intensive care. The aim of this retrospective study is reveal the risk factor of postoperative mechanical ventilation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	postoperative mechanical ventilation over 48 hours
Key secondary outcomes	use of mechanical ventilation

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	intestinal perforation patient with operation
Key exclusion criteria	intestinal perforation patient without operation
Target sample size	700

Research contact person
Name of lead principal investigator	Hijikata Toshiyuki
Organization	Itabashi Chuo Medical Center
Division name	Anesthesiology
Address	2-12-7 Azusawa Itabashi Tokyo Japan
TEL	03-3967-1181
Email	th.1984.06.01@gmail.com

Public contact
Name of contact person	Hijikata Toshiyuki
Organization	Itabashi chuo medical center
Division name	Anesthesiology
Address	2-12-7 Azusawa Itabashi, Tokyo, Japan
TEL	03-3967-1181
Homepage URL
Email	th.1984.06.01@gmail.com

Sponsor
Institute	Itabashi chuo medical center
Institute
Department

Funding Source
Organization	Non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	板橋中央総合病院

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The hospital records of all patients who were treated for intestinal perforation from 2008 to Mar. 2016 were studied. The following factors were investigated for their prognostic value: sex, age, physical findings and vital sign at emergency room, past medical history, hematological examination, imaging findings, surgical procedure, length of intensive care unit stay, use of mechanical ventilation,and mortality. Primary outcome is use of mechanical ventilation 48 hours after operation.

Management information
Registered date	2016 Year 05 Month 20 Day
Last modified on	2017 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025752