NCT04431583

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

11 years

First QC Date

June 4, 2020

Last Update Submit

June 13, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • End weight loss

    Post-operative weight loss

    Up to 12 months

Secondary Outcomes (8)

  • End weight loss

    Up to 24 months

  • End weight loss

    Up to 36 months

  • Intraoperative time

    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

    Up to 36 months

  • Number of operations performed in time period

    Retrospectively reviewed, 1 yearly

  • +3 more secondary outcomes

Study Arms (3)

2008-2012 Participants

Participants who underwent bariatric surgery between 2008 and 2012 (inclusive).

Procedure: Bariatric surgery- single surgeon service

2013-2016 Participants

Participants who underwent bariatric surgery between 2013 and 2016 (inclusive).

Procedure: Bariatric surgery- multiple surgeon + multidisciplinary team approach

2017- 2018 Participants

Participants who underwent bariatric surgery between 2017 and 2018 (inclusive).

Procedure: Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent bariatric surgery at the Queen Elizabeth Hospital (South Australia) between the years of 2008 and 2018.

You may qualify if:

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

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antonio Barbaro, MBBS

    University of Adelaide

    PRINCIPAL INVESTIGATOR
  • Harsh Kanhere, MS, FRACS, AFRACMA

    Central Adelaide Local Health Network

    STUDY DIRECTOR
  • Markus Trochsler, MD, FMH, MMIS, FRACS

    Central Adelaide Local Health Network

    STUDY DIRECTOR
  • Gayatri Asokan, MBBS, FRACS

    Central Adelaide Local Health Network

    PRINCIPAL INVESTIGATOR
  • Matheesha Herath, MBBS

    Central Adelaide Local Health Network

    PRINCIPAL INVESTIGATOR
  • Raghav Goel, MBBS

    Central Adelaide Local Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Lecturer

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 16, 2020

Study Start

January 1, 2008

Primary Completion

December 31, 2018

Study Completion

June 3, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share