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Trial registered on ANZCTR
Registration number
ACTRN12624000810516
Ethics application status
Approved
Date submitted
1/10/2023
Date registered
1/07/2024
Date last updated
1/07/2024
Date data sharing statement initially provided
1/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Investigation of Emergency Department Admissions After Bariatric Surgeries
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Scientific title
Investigation of the reasons and frequency of admission to the emergency department after bariatric surgery.
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Secondary ID [1]
310715
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bariatric Surgery
331649
0
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Post-operative Complications
332332
0
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Condition category
Condition code
Surgery
328369
328369
0
0
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Other surgery
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Emergency medicine
329045
329045
0
0
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Other emergency care
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
2
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Target follow-up type
Years
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Description of intervention(s) / exposure
Individuals with obesity who have undergone Bariatric Surgery will be examined.
Data obtained from medical records collected for the study will be evaluated.
During the follow-up period of the participants, the time of admission to the emergency department, hospitalization and surgical intervention requirements will be recorded. The observation period will be evaluated up to 2 years.
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Intervention code [1]
327114
0
Not applicable
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
336212
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Emergency service applications after discharge will be evaluated.
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Assessment method [1]
336212
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Participants' records in our hospital's electronic database will be evaluated. Complication inquiries for patients applying for surgery from outside the city where our hospital is located will be made by phone.
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Timepoint [1]
336212
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Patients who are followed for at least 1 month and at most 2 years after bariatric surgery will be evaluated.
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Secondary outcome [1]
427355
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The rate of applications requiring hospitalization will be evaluated.
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Assessment method [1]
427355
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Participants' records in our hospital's electronic database will be evaluated. Complication inquiries for patients applying for surgery from outside the city where our hospital is located will be made by phone.
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Timepoint [1]
427355
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Patients who are followed for at least 1 month and at most 2 years after bariatric surgery will be evaluated.
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Eligibility
Key inclusion criteria
Patients who underwent bariatric surgery in our hospital between June 2021 and June 2023 will be included in the study.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients whose regular records cannot be reached or who cannot be reached by phone will be excluded from evaluation
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
25/09/2023
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Date of last participant enrolment
Anticipated
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Actual
29/09/2023
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Date of last data collection
Anticipated
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Actual
27/01/2024
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Sample size
Target
200
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Accrual to date
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Final
154
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Recruitment outside Australia
Country [1]
25820
0
Turkey
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State/province [1]
25820
0
Karaman
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Funding & Sponsors
Funding source category [1]
314930
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Hospital
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Name [1]
314930
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Karaman Education and Research Hospital
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Address [1]
314930
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Üniversite Mah. 1984. sok. No: 1 . 70200. Merkez/Karaman
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Country [1]
314930
0
Turkey
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Primary sponsor type
Hospital
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Name
Karaman Education and Research Hospital
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Address
Üniversite Mah. 1984. sok. No: 1 . 70200. Merkez/Karaman
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Country
Turkey
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Secondary sponsor category [1]
316935
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None
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Name [1]
316935
0
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Address [1]
316935
0
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Country [1]
316935
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313921
0
Karamanoglu Mehmetbey Üniversity Medicine Fakulty Etihics Committee
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Ethics committee address [1]
313921
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Urgan mahallesi Turkuaz Vip konutlari. kat: 3, No: AA4. Merkez/Karaman
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Ethics committee country [1]
313921
0
Turkey
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Date submitted for ethics approval [1]
313921
0
29/05/2023
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Approval date [1]
313921
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20/06/2023
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Ethics approval number [1]
313921
0
06-2023/21
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Summary
Brief summary
In our study, we aimed to evaluate the emergency department admissions of patients who underwent bariatric surgery. This evaluation will cover a minimum of 1 month and a maximum of 2 years for each patient. The reasons for applying to the emergency department, the types of operations performed, and the rates of outpatient treatment will be evaluated.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
129798
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A/Prof Sükrü Salih Toprak
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Address
129798
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Karaman Training and Research Hospital. Üniversite mah. 1982. sok. no:1. merkez/Karaman 70200
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Country
129798
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Turkey
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Phone
129798
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+905326312408
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Fax
129798
0
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Email
129798
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[email protected]
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Contact person for public queries
Name
129799
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Sükrü Salih Toprak
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Address
129799
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Karaman Training and Research Hospital. Üniversite mah. 1982. sok. no:1. merkez/Karaman 70200
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Country
129799
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Turkey
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Phone
129799
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+905357827688
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Fax
129799
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Email
129799
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[email protected]
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Contact person for scientific queries
Name
129800
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Sükrü Salih Toprak
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Address
129800
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Karaman Training and Research Hospital. Üniversite mah. 1982. sok. no:1. merkez/Karaman 70200
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Country
129800
0
Turkey
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Phone
129800
0
+905357827688
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Fax
129800
0
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Email
129800
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Retrospective
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20548
Ethical approval
Karamanoglu Mehmetbey University Faculty of Medicine Ethics Committee
https://kmu.edu.tr/tip/sayfa/4851/karamanoglu-mehmetbey-universitesi-tip-fakultesi-yerel-bilimsel-tibbi-arastirmalar-etik-kurulu/tr
[email protected]
by emailing the principal investigator
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF