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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033032
Receipt No. R000037636
Scientific Title Effect of hospital and surgeon volume on mortality following major operations: umbrella review of meta-analyses of observational studies
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/18

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Basic information
Public title Effect of hospital and surgeon volume on mortality following major operations: umbrella review of meta-analyses of observational studies
Acronym Hospital/surgeon volume and mortality
Scientific Title Effect of hospital and surgeon volume on mortality following major operations: umbrella review of meta-analyses of observational studies
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshiya Shiga
Organization International University of Health and Welfare Ichikawa Hospital
Division name Department of Anesthesiology
Zip code
Address Konodai,
TEL 047-375-1111
Email qzx02115@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Toshiya Shiga
Organization International University of Health and Welfare Ichikawa Hospital
Division name Department of Anesthesiology
Zip code
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)

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
2018 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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