- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431583
Transition of Single Surgeon Bariatric Service to an Interdisciplinary Multiple Surgeon Model
June 13, 2020 updated by: Antonio Barbaro, University of Adelaide
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
146
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent bariatric surgery at the Queen Elizabeth Hospital (South Australia) between the years of 2008 and 2018.
Description
Inclusion Criteria:
- Participants must have had bariatric surgery at The Queen Elizabeth Hospital between 2008-2018
Exclusion Criteria:
- nil
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
2008-2012 Participants
Participants who underwent bariatric surgery between 2008 and 2012 (inclusive).
|
|
|
2013-2016 Participants
Participants who underwent bariatric surgery between 2013 and 2016 (inclusive).
|
|
|
2017- 2018 Participants
Participants who underwent bariatric surgery between 2017 and 2018 (inclusive).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
Time Frame: Up to 12 months
|
Post-operative weight loss
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
End weight loss
Time Frame: Up to 24 months
|
Post-operative weight loss
|
Up to 24 months
|
|
End weight loss
Time Frame: Up to 36 months
|
Post-operative weight loss
|
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.
|
Duration of operative time measured in minutes
|
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
|
Complications which occurred in the post operative period
|
Up to 36 months
|
|
Number of operations performed in time period
Time Frame: Retrospectively reviewed, 1 yearly
|
The number of operations which occurred in each group
|
Retrospectively reviewed, 1 yearly
|
|
Type of Operation Performed
Time Frame: Retrospectively reviewed, 1 yearly
|
The number of the different types of bariatric operations which occurred in each group
|
Retrospectively reviewed, 1 yearly
|
|
Number of participants converted from Gastric Sleeve to Gastric Bypass
Time Frame: Retrospectively reviewed, 1 yearly
|
Retrospectively reviewed, 1 yearly
|
|
|
Number of patients on surgical waitlist
Time Frame: Retrospectively reviewed, 1 yearly
|
The number of patients on the surgical waitlist for each time period
|
Retrospectively reviewed, 1 yearly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Antonio Barbaro, MBBS, University of Adelaide
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
June 3, 2020
Study Registration Dates
First Submitted
June 4, 2020
First Submitted That Met QC Criteria
June 11, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 13, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 13204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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