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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04524429




Registration number
NCT04524429
Ethics application status
Date submitted
19/08/2020
Date registered
24/08/2020

Titles & IDs
Public title
Quality of Life After Bariatric Surgery
Scientific title
Quality of Life After Bariatric Surgery
Secondary ID [1] 0 0
13441
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bariatric Surgery Candidate 0 0
Obesity 0 0
Obesity, Morbid 0 0
Quality of Life 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Bariatric Surgery

Pre-operative Group - This is the group of participants who suffer from obesity and are awaiting bariatric surgery.

Post-operative Group - This is the group of participants who suffer from obesity and have received bariatric surgery.


Treatment: Surgery: Bariatric Surgery
Bariatric surgery includes sleeve gastrectomy and gastric bypass.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quality of life before and after bariatric surgery
Assessment method [1] 0 0
Difference in SF-36 between post-bariatric surgical patients and representative pre-operative patients who have not undergone bariatric surgery (quality of life).
Timepoint [1] 0 0
This represents the patients current quality of life within the last 4 weeks.
Secondary outcome [1] 0 0
Current Weight
Assessment method [1] 0 0
This represents the patients current weight in kilograms.
Timepoint [1] 0 0
This is the patients current weight within the last 4 weeks
Secondary outcome [2] 0 0
Lowest Weight
Assessment method [2] 0 0
This represents the patients lowest weight after bariatric surgery
Timepoint [2] 0 0
Retrospectively reviewed on average of 5 years
Secondary outcome [3] 0 0
Change in marker of Type 2 Diabetes Mellitus
Assessment method [3] 0 0
Using HbA1C scores and use of insulin
Timepoint [3] 0 0
Preoperative use compared to results within the last 4 weeks
Secondary outcome [4] 0 0
Change in marker of hypertension
Assessment method [4] 0 0
Number of medications used to manage condition
Timepoint [4] 0 0
Preoperative use compared with use in the last 4 weeks
Secondary outcome [5] 0 0
Change in marker of hyperlipidemia
Assessment method [5] 0 0
Number of medications used to manage condition
Timepoint [5] 0 0
Preoperative use compared with use in the last 4 weeks
Secondary outcome [6] 0 0
Change in marker of GORD
Assessment method [6] 0 0
Number of medications used to manage condition
Timepoint [6] 0 0
Preoperative use compared with use in the last 4 weeks
Secondary outcome [7] 0 0
Change in marker of OSA
Assessment method [7] 0 0
Use of CPAP
Timepoint [7] 0 0
Preoperative use compared with use in the last 4 weeks

Eligibility
Key inclusion criteria
* Obese, either received bariatric surgery or have been referred for bariatric surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Emergency cases, Obese patients who have not been referred for bariatric surgery.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2021
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5011 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Central Adelaide Local Health Network Incorporated
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Antonio Barbaro, MBBS
Address 0 0
University of Adelaide, Central Adelaide Local Health Network
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Antonio Barbaro, MBBS
Address 0 0
Country 0 0
Phone 0 0
8222 6000
Email 0 0
antonio.barbaro@sa.gov.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04524429