UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of hospital and surgeon volume on mortality following major operations: umbrella review of meta-analyses of observational studies
Title of the study (Brief title)	Hospital/surgeon volume and mortality
Region	Japan

Condition
Condition	Patients undergoing surgery
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The goal of this study was to perform an umbrella review of systematic reviews and meta-analyses, to summarize the evidence, and to evaluate the validity and presence of biases in the relations between hospital/surgeon volume and mortality for a wide variety of major operations.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	in-hospital or 30-day morality
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing major surgery
Key exclusion criteria	Pediatric surgery, coronary intervention, intervention not referred to surgery
Target sample size	100000

Research contact person
Name of lead principal investigator	Toshiya Shiga
Organization	International University of Health and Welfare Ichikawa Hospital
Division name	Department of Anesthesiology
Address	Konodai,
TEL	047-375-1111
Email	qzx02115@nifty.com

Public contact
Name of contact person	Toshiya Shiga
Organization	International University of Health and Welfare Ichikawa Hospital
Division name	Department of Anesthesiology
Address	Konodai,
TEL	047-375-1111
Homepage URL
Email	qzx02115@nifty.com

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	International University of Health and Welfare
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 06 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 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	Partially published
URL releasing results
Results
Other related information	Nineteen meta-analyses were identified for hospital-mortality associations, and 11 meta-analyses were identified for surgeon-mortality associations. For hospital-mortality associations, high hospital volume was significantly associated with lower mortality in 16 meta-analyses (84%) with summary random effect estimates. The presence of publication bias was identified in only 2 meta-analyses (11%), and 11 meta-analyses (58%) had substantial heterogeneity (I2>75%). For surgeon-mortality associations, high surgeon volume was significantly associated with lower mortality in 9 meta-analyses (82%). The presence of publication bias was identified in only 1 meta-analysis (18%), and 2 meta-analyses (%) had substantial heterogeneity (I2>75%). The 95% prediction intervals excluded the null value for 5 operations (pancreaticoduodenectomy, repair of ruptured and unruptured abdominal aortic aneurysm, and colorectal or esophageal cancer resection).

Management information
Registered date	2018 Year 06 Month 18 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037636