Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001544268
Ethics application status
Approved
Date submitted
10/09/2018
Date registered
14/09/2018
Date last updated
14/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term follow up after Sleeve gastrectomy: a single center observational study
Scientific title
Long-term follow up after Sleeve gastrectomy: a single center observational study
Secondary ID [1] 296050 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 309603 0
Condition category
Condition code
Surgery 308421 308421 0 0
Surgical techniques
Diet and Nutrition 308426 308426 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
private setting: patients with obesity who wish to undergo sleeve gastrectomy are followed-up after the procedure. complications as well as consumption of in hospital care are recorded. Follow up is 5 years.
Intervention code [1] 312389 0
Diagnosis / Prognosis
Comparator / control treatment
patients are compared to individuals that have not undergone sleeve gastrectomy. data are extracted from the swedish population register and are matched for age and sex to the patients
Control group
Historical

Outcomes
Primary outcome [1] 307384 0
complications, assessed by feedback from patients and records from hospitals
Timepoint [1] 307384 0
assessed after the operation at 3 months, 6 months, 1 year, 3 years and 5 years.
Primary outcome [2] 307392 0
recording of in-hospital care healthcare resource consumption assessed by feedback from patients and records from hospitals
Timepoint [2] 307392 0
assessed after the operation at 3 months, 6 months, 1 year, 3 years and 5 years.
Secondary outcome [1] 351746 0
nil
Timepoint [1] 351746 0
nil

Eligibility
Key inclusion criteria
patients that have undergone sleeve gastrectomy at our center
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who previously underwent an obesity procedure

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/04/2007
Date of last participant enrolment
Anticipated
Actual
31/03/2012
Date of last data collection
Anticipated
Actual
6/02/2017
Sample size
Target
862
Accrual to date
Final
862
Recruitment outside Australia
Country [1] 20835 0
Sweden
State/province [1] 20835 0

Funding & Sponsors
Funding source category [1] 300639 0
University
Name [1] 300639 0
Uppsala University
Country [1] 300639 0
Sweden
Primary sponsor type
University
Name
Uppsala University
Address
Department of Surgical Sciences
Uppsala University
SE-751 85 Uppsala
Country
Sweden
Secondary sponsor category [1] 300151 0
None
Name [1] 300151 0
Address [1] 300151 0
Country [1] 300151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301427 0
Regionala Etikprövningsnämnden i Uppsala
Ethics committee address [1] 301427 0
Uppsala
Ethics committee country [1] 301427 0
Sweden
Date submitted for ethics approval [1] 301427 0
Approval date [1] 301427 0
25/09/2006
Ethics approval number [1] 301427 0

Summary
Brief summary
Regionala Etikprövningsnämnden i Uppsala approved inclusion of patients who underwent sleeve gastrectomy at our clinic for follow up. The patients accepted participation in the project and were followed up for at least 5 years. We recorded complications after the procedure as well as consumption of in-hospital care.

Our objective was to evaluate complications and need for additional in-hospital care in the long-term after sleeve gastrectomy for obesity patients, all operated at a single center.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86958 0
Dr Thanos P Kakoulidis
Address 86958 0
Department of Surgical Sciences
Uppsala University
Entrance 70
SE-751 85 Uppsala
Country 86958 0
Sweden
Phone 86958 0
+46733853613
Fax 86958 0
Email 86958 0
[email protected]
Contact person for public queries
Name 86959 0
Dr Thanos P Kakoulidis
Address 86959 0
Department of Surgical Sciences
Uppsala University
Entrance 70
SE-751 85 Uppsala
Country 86959 0
Sweden
Phone 86959 0
+46733853613
Fax 86959 0
Email 86959 0
[email protected]
Contact person for scientific queries
Name 86960 0
Dr Thanos P Kakoulidis
Address 86960 0
Department of Surgical Sciences
Uppsala University
Entrance 70
SE-751 85 Uppsala
Country 86960 0
Sweden
Phone 86960 0
+46733853613
Fax 86960 0
Email 86960 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.