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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04524429




Registration number
NCT04524429
Ethics application status
Date submitted
19/08/2020
Date registered
24/08/2020
Date last updated
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
Timepoint [1] 0 0
This represents the patients current quality of life within the last 4 weeks.
Secondary outcome [1] 0 0
Current Weight
Timepoint [1] 0 0
This is the patients current weight within the last 4 weeks
Secondary outcome [2] 0 0
Lowest Weight
Timepoint [2] 0 0
Retrospectively reviewed on average of 5 years
Secondary outcome [3] 0 0
Change in marker of Type 2 Diabetes Mellitus
Timepoint [3] 0 0
Preoperative use compared to results within the last 4 weeks
Secondary outcome [4] 0 0
Change in marker of hypertension
Timepoint [4] 0 0
Preoperative use compared with use in the last 4 weeks
Secondary outcome [5] 0 0
Change in marker of hyperlipidemia
Timepoint [5] 0 0
Preoperative use compared with use in the last 4 weeks
Secondary outcome [6] 0 0
Change in marker of GORD
Timepoint [6] 0 0
Preoperative use compared with use in the last 4 weeks
Secondary outcome [7] 0 0
Change in marker of OSA
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 status
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Central Adelaide Local Health Network Incorporated
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to assess long term outcomes for patients who have underwent bariatric
surgery. In particular, it aims to assess the quality of life of these participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04524429
Trial related presentations / publications
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
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04524429