UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Nomogram predicting postoperative pneumonia after major abdominal surgery
Title of the study (Brief title)	predictors of postoperative pneumonia
Region	Japan

Condition
Condition	postoperative pneumonia
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study was to devise a model for stratification of the probability of POP (postoperative pneumonia) in patients undergoing abdominal surgery, based on the evaluation of the predictive factors for POP.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Age, male sex, history of cerebrovascular disease, BI, and upper midline incision were the independent predictive factors for POP in patients who underwent major abdominal surgery. A nomogram based on these factors was useful for identifying patients with a high probability of developing POP.
Key secondary outcomes

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	16 years-old <=
Age-upper limit	96 years-old >=
Gender	Male and Female
Key inclusion criteria	From April 2012 to December 2013, a total of 1,666 consecutive patients underwent abdominal surgery under general anesthesia.
Key exclusion criteria	Patients who underwent less invasive abdominal surgery procedures, such as appendectomy, laparoscopic cholecystectomy, abdominal wall hernioplasty, and explorative laparotomy, were excluded from the analysis.
Target sample size	1050

Research contact person
Name of lead principal investigator	Yoshikuni Kawaguchi
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	+81-3-3815-5411
Email	yokawaguchi-tky@umin.ac.jp

Public contact
Name of contact person	Keishi Kawasaki
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL	043-222-7171
Homepage URL
Email	keishi1231@chiba-u.jp

Sponsor
Institute	Asahi General Hospital
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	N/A

Management information
Registered date	2018 Year 08 Month 22 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038613