We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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/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
antonio.barbaro@sa.gov.au
Contact person for scientific queries

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