Trial Review

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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
Scientific title
Investigation of the reasons and frequency of admission to the emergency department after bariatric surgery.
Secondary ID [1] 310715 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bariatric Surgery
 331649 0
Post-operative Complications 332332 0
Condition category
Condition code
Surgery 328369 328369 0 0
Other surgery
Emergency medicine 329045 329045 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
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.
Intervention code [1] 327114 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336212 0
Emergency service applications after discharge will be evaluated.
Timepoint [1] 336212 0
Patients who are followed for at least 1 month and at most 2 years after bariatric surgery will be evaluated.
Secondary outcome [1] 427355 0
The rate of applications requiring hospitalization will be evaluated.
Timepoint [1] 427355 0
Patients who are followed for at least 1 month and at most 2 years after bariatric surgery will be evaluated.

Eligibility
Key inclusion criteria
Patients who underwent bariatric surgery in our hospital between June 2021 and June 2023 will be included in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients whose regular records cannot be reached or who cannot be reached by phone will be excluded from evaluation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/09/2023
Date of last participant enrolment
Anticipated
Actual
29/09/2023
Date of last data collection
Anticipated
Actual
27/01/2024
Sample size
Target
200
Accrual to date
Final
154
Recruitment outside Australia
Country [1] 25820 0
Turkey
State/province [1] 25820 0
Karaman

Funding & Sponsors
Funding source category [1] 314930 0
Hospital
Name [1] 314930 0
Karaman Education and Research Hospital
Country [1] 314930 0
Turkey
Primary sponsor type
Hospital
Name
Karaman Education and Research Hospital
Address
Üniversite Mah. 1984. sok. No: 1 . 70200. Merkez/Karaman
Country
Turkey
Secondary sponsor category [1] 316935 0
None
Name [1] 316935 0
Address [1] 316935 0
Country [1] 316935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313921 0
Karamanoglu Mehmetbey Üniversity Medicine Fakulty Etihics Committee
Ethics committee address [1] 313921 0
Ethics committee country [1] 313921 0
Turkey
Date submitted for ethics approval [1] 313921 0
29/05/2023
Approval date [1] 313921 0
20/06/2023
Ethics approval number [1] 313921 0
06-2023/21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129798 0
A/Prof Sükrü Salih Toprak
Address 129798 0
Karaman Training and Research Hospital. Üniversite mah. 1982. sok. no:1. merkez/Karaman 70200
Country 129798 0
Turkey
Phone 129798 0
+905326312408
Fax 129798 0
Email 129798 0
drsstbir@gmail.com
Contact person for public queries
Name 129799 0
Sükrü Salih Toprak
Address 129799 0
Karaman Training and Research Hospital. Üniversite mah. 1982. sok. no:1. merkez/Karaman 70200
Country 129799 0
Turkey
Phone 129799 0
+905357827688
Fax 129799 0
Email 129799 0
dr.tprk@hotmail.com
Contact person for scientific queries
Name 129800 0
Sükrü Salih Toprak
Address 129800 0
Karaman Training and Research Hospital. Üniversite mah. 1982. sok. no:1. merkez/Karaman 70200
Country 129800 0
Turkey
Phone 129800 0
+905357827688
Fax 129800 0
Email 129800 0
dr.tprk@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Retrospective


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20548Ethical approvalKaramanoglu Mehmetbey University Faculty of Medicine Ethics Committeehttps://kmu.edu.tr/tip/sayfa/4851/karamanoglu-mehmetbey-universitesi-tip-fakultesi-yerel-bilimsel-tibbi-arastirmalar-etik-kurulu/trdrsstbir@gmail.com 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.