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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04431583
Other study ID # 13204
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date June 3, 2020

Study information

Verified date June 2020
Source University of Adelaide
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date June 3, 2020
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Participants must have had bariatric surgery at The Queen Elizabeth Hospital between 2008-2018

Exclusion Criteria:

- nil

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bariatric surgery- single surgeon service

Bariatric surgery- multiple surgeon + multidisciplinary team approach

Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Adelaide Central Adelaide Local Health Network Incorporated

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative length of stay (nights) 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.
Primary End weight loss Post-operative weight loss Up to 12 months
Secondary End weight loss Post-operative weight loss Up to 24 months
Secondary End weight loss Post-operative weight loss Up to 36 months
Secondary Intraoperative time 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.
Secondary Post-operative complications Complications which occurred in the post operative period Up to 36 months
Secondary Number of operations performed in time period The number of operations which occurred in each group Retrospectively reviewed, 1 yearly
Secondary Type of Operation Performed The number of the different types of bariatric operations which occurred in each group Retrospectively reviewed, 1 yearly
Secondary Number of participants converted from Gastric Sleeve to Gastric Bypass Retrospectively reviewed, 1 yearly
Secondary Number of patients on surgical waitlist The number of patients on the surgical waitlist for each time period Retrospectively reviewed, 1 yearly
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