NCT04524429

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 23, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 19, 2020

Last Update Submit

August 19, 2020

Conditions

Bariatric Surgery CandidateObesityObesity, MorbidQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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).

    This represents the patients current quality of life within the last 4 weeks.

Secondary Outcomes (7)

  • Current Weight

    This is the patients current weight within the last 4 weeks

  • Lowest Weight

    Retrospectively reviewed on average of 5 years

  • Change in marker of Type 2 Diabetes Mellitus

    Preoperative use compared to results within the last 4 weeks

  • Change in marker of hypertension

    Preoperative use compared with use in the last 4 weeks

  • Change in marker of hyperlipidemia

    Preoperative use compared with use in the last 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

Procedure: Bariatric Surgery

Interventions

Bariatric SurgeryPROCEDURE

Bariatric surgery includes sleeve gastrectomy and gastric bypass.

Post-operative Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Obese, either received bariatric surgery or have been referred for bariatric surgery.

You may not qualify if:

  • Emergency cases, Obese patients who have not been referred for bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

RECRUITING

MeSH Terms

Conditions

ObesityObesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Antonio Barbaro, MBBS

    University of Adelaide, 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

  • Gayatri Asokan, MBBS, FRACS

    Central Adelaide Local Health Network

    PRINCIPAL INVESTIGATOR

  • Markus Trochsler, MD, FMH, MMIS, FRACS

    Central Adelaide Local Health Network

    STUDY DIRECTOR

  • Harsh Kanhere, MS, FRACS, AFRACMA

    Central Adelaide Local Health Network

    STUDY DIRECTOR

Central Study Contacts

Antonio Barbaro, MBBS

CONTACT

8222 6000antonio.barbaro@sa.gov.au

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

August 19, 2020

First Posted

August 24, 2020

Study Start

June 23, 2020

Primary Completion

December 20, 2020

Study Completion

February 1, 2021

Last Updated

August 24, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)