ObesityNCT04431583
Transition of Single Surgeon Bariatric Service to an Interdisciplinary Multiple Surgeon Model
An observational study of Obesity and Bariatric Surgery Candidate, run by University of Adelaide.
Trial summary
This retrospective study will analyse the transition of an Australian hospital which significantly increased volume of bariatric operations after introduction of a clinical pathway, and to assess the outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- Bariatric surgery- single surgeon service, Bariatric surgery- multiple surgeon + multidisciplinary team approach and Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 3 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent bariatric surgery at the Queen Elizabeth Hospital (South Australia) between the years of 2008 and 2018.
Who may be able to join
- Participants must have had bariatric surgery at The Queen Elizabeth Hospital between 2008-2018
Who cannot join
- nil
About this study
This retrospective study will analyse the transition of an Australian hospital which significantly increased volume of bariatric operations after introduction of a clinical pathway, and to assess the outcomes. Barriers to introduction of the multidisciplinary pathway and the means to overcome these will also be analysed and discussed. The analysis will also determine if there are any other areas of bariatric surgery which can be further investigated to optimise current practice.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- Bariatric surgery- single surgeon service, Bariatric surgery- multiple surgeon + multidisciplinary team approach, Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgery- single surgeon serviceProcedure or surgery
Bariatric surgery- multiple surgeon + multidisciplinary team approachProcedure or surgery
Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approachProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 2008-2012 Participants | Participants who underwent bariatric surgery between 2008 and 2012 (inclusive). Receives: Procedure: Bariatric surgery- single surgeon service | |
| 2013-2016 Participants | Participants who underwent bariatric surgery between 2013 and 2016 (inclusive). Receives: Procedure: Bariatric surgery- multiple surgeon + multidisciplinary team approach | |
| 2017- 2018 Participants | Participants who underwent bariatric surgery between 2017 and 2018 (inclusive). Receives: Procedure: Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative length of stay (nights)
This will be measured in number of nights the participant stayed in hospital after the procedure.
Measured: The number of nights the participant stay in hospital from the day of procedure to the day of hospital discharge. This time period occurs immediately after the procedure. This data will be retrospectively reviewed on an average of 5 years.
End weight loss
Post-operative weight loss
Measured: Up to 12 months
Secondary outcomes (8)
End weight loss
Post-operative weight loss
Measured: Up to 24 months
End weight loss
Post-operative weight loss
Measured: Up to 36 months
Intraoperative time
Duration of operative time measured in minutes
Measured: The start time of the operation to the end time of the procedure. This data will be retrospectively reviewed on an average of 5 years.
Post-operative complications
Complications which occurred in the post operative period
Measured: Up to 36 months
Number of operations performed in time period
The number of operations which occurred in each group
Measured: Retrospectively reviewed, 1 yearly
Type of Operation Performed
The number of the different types of bariatric operations which occurred in each group
Measured: Retrospectively reviewed, 1 yearly
Number of participants converted from Gastric Sleeve to Gastric Bypass
Measured: Retrospectively reviewed, 1 yearly
Number of patients on surgical waitlist
The number of patients on the surgical waitlist for each time period
Measured: Retrospectively reviewed, 1 yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jan 2008
- Primary completion31 Dec 2018
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 146 participants (actual)
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 AdelaideHarsh Kanhere, MS, FRACS, AFRACMA, Study director, Central Adelaide Local Health NetworkMarkus Trochsler, MD, FMH, MMIS, FRACS, Study director, Central Adelaide Local Health NetworkGayatri Asokan, MBBS, FRACS, Principal investigator, Central Adelaide Local Health NetworkMatheesha Herath, MBBS, Principal investigator, Central Adelaide Local Health NetworkRaghav Goel, MBBS, Principal investigator, Central Adelaide Local Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431583
- Sponsor's protocol ID
- 13204
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition of Single Surgeon Bariatric Service to an Interdisciplinary Multiple Surgeon Model
- ClinicalTrials.gov ID
- NCT04431583
- Acronym / sponsor ID
- 13204
- Conditions
- Obesity, Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- Central Adelaide Local Health Network Incorporated
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 16 Jun 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 retrospective study will analyse the transition of an Australian hospital which significantly increased volume of bariatric operations after introduction of a clinical pathway, and to assess the outcomes. Barriers to introduction of the multidisciplinary pathway and the means to overcome these will also be analysed and discussed. The analysis will also determine if there are any other areas of bariatric surgery which can be further investigated to optimise current practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2008-2012 Participants | – | Procedure: Bariatric surgery- single surgeon serviceParticipants who underwent bariatric surgery between 2008 and 2012 (inclusive). |
| 2013-2016 Participants | – | Procedure: Bariatric surgery- multiple surgeon + multidisciplinary team approachParticipants who underwent bariatric surgery between 2013 and 2016 (inclusive). |
| 2017- 2018 Participants | – | Procedure: Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approachParticipants who underwent bariatric surgery between 2017 and 2018 (inclusive). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent bariatric surgery at the Queen Elizabeth Hospital (South Australia) between the years of 2008 and 2018.
Key inclusion criteria (1 listed)
- Participants must have had bariatric surgery at The Queen Elizabeth Hospital between 2008-2018
Key exclusion criteria (1 listed)
- nil
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 surgery- single surgeon service | Procedure or surgery | 2008-2012 Participants |
| Bariatric surgery- multiple surgeon + multidisciplinary team approach | Procedure or surgery | 2013-2016 Participants |
| Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach | Procedure or surgery | 2017- 2018 Participants |
Primary outcome
Post-operative length of stay (nights)
Time frame: The number of nights the participant stay in hospital from the day of procedure to the day of hospital discharge. This time period occurs immediately after the procedure. This data will be retrospectively reviewed on an average of 5 years.
This will be measured in number of nights the participant stayed in hospital after the procedure.
End weight loss
Time frame: Up to 12 months
Post-operative weight loss
8 secondary outcomes
End weight loss
Time frame: Up to 24 months
End weight loss
Time frame: Up to 36 months
Intraoperative time
Time frame: The start time of the operation to the end time of the procedure. This data will be retrospectively reviewed on an average of 5 years.
Post-operative complications
Time frame: Up to 36 months
Number of operations performed in time period
Time frame: Retrospectively reviewed, 1 yearly
Type of Operation Performed
Time frame: Retrospectively reviewed, 1 yearly
Number of participants converted from Gastric Sleeve to Gastric Bypass
Time frame: Retrospectively reviewed, 1 yearly
Number of patients on surgical waitlist
Time frame: Retrospectively reviewed, 1 yearly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 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
Harsh Kanhere, MS, FRACS, AFRACMA study director
Central Adelaide Local Health Network
Markus Trochsler, MD, FMH, MMIS, FRACS study director
Central Adelaide Local Health Network
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery Candidate, run by University of Adelaide.
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: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative length of stay (nights) (time frame: The number of nights the participant stay in hospital from the day of procedure to the day of hospital discharge. This time period occurs immediately after the procedure. This data will be retrospectively reviewed on an average of 5 years.). The study lists 2 primary outcomes in all. 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 16 Jun 2020.