Quality of Life After Bariatric Surgery

Obesity Clinical Trial

Official title:

Quality of Life After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04524429
• Other study ID #: 13441
• Status: Recruiting
• Start date: June 23, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: August 2020
• Source: University of Adelaide
• Contact: Antonio Barbaro, MBBS
• Phone: 8222 6000
• Email: antonio.barbaro[@]sa.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Obesity, Morbid
• Quality of Life

Intervention

Procedure:
• Bariatric Surgery
Bariatric surgery includes sleeve gastrectomy and gastric bypass.

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Adelaide	South Australia

Sponsors (2)

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

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Current Weight	This represents the patients current weight in kilograms.	This is the patients current weight within the last 4 weeks
Secondary	Lowest Weight	This represents the patients lowest weight after bariatric surgery	Retrospectively reviewed on average of 5 years
Secondary	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
Secondary	Change in marker of hypertension	Number of medications used to manage condition	Preoperative use compared with use in the last 4 weeks
Secondary	Change in marker of hyperlipidemia	Number of medications used to manage condition	Preoperative use compared with use in the last 4 weeks
Secondary	Change in marker of GORD	Number of medications used to manage condition	Preoperative use compared with use in the last 4 weeks
Secondary	Change in marker of OSA	Use of CPAP	Preoperative use compared with use in the last 4 weeks