Quality of Life After Bariatric Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Obesity; Obesity, Morbid; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Bariatric Surgery

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Antonio Barbaro, MBBS; Phone Number: 08 8222 6000; Email: antonio.barbaro@sa.gov.au

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5011
      • Recruiting
      • The Queen Elizabeth Hospital
      • Contact: Antonio Barbaro, MBBS; Phone Number: 04 39041523; Email: antonio.barbaro@sa.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Bariatric surgery includes sleeve gastrectomy and gastric bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current Weight	This represents the patients current weight in kilograms.	This is the patients current weight within the last 4 weeks
Lowest Weight	This represents the patients lowest weight after bariatric surgery	Retrospectively reviewed on average of 5 years
Change in marker of Type 2 Diabetes Mellitus	Using HbA1C scores and use of insulin	Preoperative use compared to results within the last 4 weeks
Change in marker of hypertension	Number of medications used to manage condition	Preoperative use compared with use in the last 4 weeks
Change in marker of hyperlipidemia	Number of medications used to manage condition	Preoperative use compared with use in the last 4 weeks
Change in marker of GORD	Number of medications used to manage condition	Preoperative use compared with use in the last 4 weeks
Change in marker of OSA	Use of CPAP	Preoperative use compared with use in the last 4 weeks

Collaborators and Investigators

• Sponsor: University of Adelaide
• Collaborators: Central Adelaide Local Health Network Incorporated
• Investigators: Principal Investigator: Antonio Barbaro, MBBS, University of Adelaide, Central Adelaide Local Health Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2020
• Primary Completion (ANTICIPATED): December 20, 2020
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 13441

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