Bariatric Surgery CandidateNCT04524429
Quality of Life After Bariatric Surgery
An observational study of Bariatric Surgery Candidate and Obesity, run by University of Adelaide at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Obesity, Morbid
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Jun 2020to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pre-operative Group The pre-operative population will be patients who have been referred to TQEH bariatric clinic however have not yet had their initial appointment. The 150 participants who have been on the waiting list for the longest period of time will be included in the pre-operative group. Post-operative Group The post-operative population will be the 140 patients who underwent bariatric surgery at TQEH between 2008 and 2018. This resulted in 146 operations.
Who may be able to join
- Obese, either received bariatric surgery or have been referred for bariatric surgery.
Who cannot join
- Emergency cases, Obese patients who have not been referred for bariatric surgery.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Antonio Barbaro, MBBS, 39041523 ext. 04, antonio.barbaro@sa.gov.au
About this study
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.
- Conditions
- Bariatric Surgery Candidate, Obesity, Obesity, Morbid, Quality of Life
- Being tested
- Bariatric Surgery
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Bariatric surgery includes sleeve gastrectomy and gastric bypass.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: This represents the patients current quality of life within the last 4 weeks.
Secondary outcomes (7)
Current Weight
This represents the patients current weight in kilograms.
Measured: This is the patients current weight within the last 4 weeks
Lowest Weight
This represents the patients lowest weight after bariatric surgery
Measured: Retrospectively reviewed on average of 5 years
Change in marker of Type 2 Diabetes Mellitus
Using HbA1C scores and use of insulin
Measured: Preoperative use compared to results within the last 4 weeks
Change in marker of hypertension
Number of medications used to manage condition
Measured: Preoperative use compared with use in the last 4 weeks
Change in marker of hyperlipidemia
Number of medications used to manage condition
Measured: Preoperative use compared with use in the last 4 weeks
Change in marker of GORD
Number of medications used to manage condition
Measured: Preoperative use compared with use in the last 4 weeks
Change in marker of OSA
Use of CPAP
Measured: Preoperative use compared with use in the last 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start23 Jun 2020
- Primary completion20 Dec 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- Central Adelaide Local Health Network Incorporated
- Responsible party
- Principal investigator, Antonio Barbaro, University of Adelaide
- Investigators
- Antonio Barbaro, MBBS, Principal investigator, University of Adelaide, Central Adelaide Local Health NetworkMatheesha Herath, MBBS, Principal investigator, Central Adelaide Local Health NetworkRaghav Goel, MBBS, Principal investigator, Central Adelaide Local Health NetworkGayatri Asokan, MBBS, FRACS, Principal investigator, Central Adelaide Local Health NetworkMarkus Trochsler, MD, FMH, MMIS, FRACS, Study director, Central Adelaide Local Health NetworkHarsh Kanhere, MS, FRACS, AFRACMA, Study director, Central Adelaide Local Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524429
- Sponsor's protocol ID
- 13441
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04524429
- Acronym / sponsor ID
- 13441
- Conditions
- Bariatric Surgery Candidate, Obesity, Obesity, Morbid, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- Central Adelaide Local Health Network Incorporated
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative Group | – | –This is the group of participants who suffer from obesity and are awaiting bariatric surgery. |
| Post-operative Group | – | Procedure: Bariatric SurgeryThis is the group of participants who suffer from obesity and have received bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-operative Group The pre-operative population will be patients who have been referred to TQEH bariatric clinic however have not yet had their initial appointment. The 150 participants who have been on the waiting list for the longest period of time will be included in the pre-operative group. Post-operative Group The post-operative population will be the 140 patients who underwent bariatric surgery at TQEH between 2008 and 2018. This resulted in 146 operations.
Key inclusion criteria (1 listed)
- Obese, either received bariatric surgery or have been referred for bariatric surgery.
Key exclusion criteria (1 listed)
- Emergency cases, Obese patients who have not been referred for bariatric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryBariatric surgery includes sleeve gastrectomy and gastric bypass. | Procedure or surgery | Post-operative Group |
Primary outcome
Quality of life before and after bariatric surgery
Time frame: This represents the patients current quality of life within the last 4 weeks.
Difference in SF-36 between post-bariatric surgical patients and representative pre-operative patients who have not undergone bariatric surgery (quality of life).
7 secondary outcomes
Current Weight
Time frame: This is the patients current weight within the last 4 weeks
Lowest Weight
Time frame: Retrospectively reviewed on average of 5 years
Change in marker of Type 2 Diabetes Mellitus
Time frame: Preoperative use compared to results within the last 4 weeks
Change in marker of hypertension
Time frame: Preoperative use compared with use in the last 4 weeks
Change in marker of hyperlipidemia
Time frame: Preoperative use compared with use in the last 4 weeks
Change in marker of GORD
Time frame: Preoperative use compared with use in the last 4 weeks
Change in marker of OSA
Time frame: Preoperative use compared with use in the last 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Barbaro, MBBS principal investigator
University of Adelaide, Central Adelaide Local Health Network
Matheesha Herath, MBBS principal investigator
Central Adelaide Local Health Network
Raghav Goel, MBBS principal investigator
Central Adelaide Local Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Obesity, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Barbaro, MBBS (8222 6000 ext. 08, antonio.barbaro@sa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life before and after bariatric surgery (time frame: This represents the patients current quality of life within the last 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.