Plain English Summary
Background and study aims
Bariatric surgery is a type of surgery performed on people who are obese with the purpose of making them lose weight - this includes gastric bypass and gastric banding. It is an increasingly common operation yet the long term benefits and complications are not well known. This study will collect data on every patient in Scotland having weight loss surgery, to monitor their weight, nutrient levels in their blood, whether diabetes gets better or if they develop diabetes in the future, any complications such as wound infections or requiring a second operation, heart attacks, cancer or if they die, and if quality of life improves and they feel more or less anxious or depressed after the surgery. We will follow the patients for 10 years after their surgery.
Who can participate?
Participants will be people undergoing bariatric surgery in Scotland - either in the NHS or private hospitals.
What does the study involve?
The study will follow patients during their normal care before and after surgery. No additional tests will be performed. Results of blood tests and details of any future hospital admissions will be gathered using the data stored in Scottish NHS computer systems. For participants with diabetes, data on their diabetes control, medications and complications will be gathered again from NHS computer systems. Participants will be contacted by post before the operation and annually after the operation to complete a questionnaire on quality of life and also be asked if they have had any complications relate to their surgery. They will be phoned 30 days after surgery to be asked how they are recovering from the surgery.
What are the possible benefits and risks of participating?
There are no benefits or risks to the participants.
Where is the study run from?
The study is run by the University of Glasgow with all NHS and private hospitals providing bariatric surgery in Scotland being involved.
When is the study starting and how long is it expected to run for?
The study will start in January 2012. Participants will be recruited until January 2017 and all participants will be followed up until July 2026.
Who is funding the study?
The National Institute of Health Research Health Technology Appraisal Scheme.
Who is the main contact?
Dr Jennifer Logue
Jennifer.Logue@Glasgow.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 10/42/02
Study information
Scientific title
SurgiCal Obesity Treatment Study: a prospective cohort study
Acronym
SCOTS
Study hypothesis
To establish in a cohort of obese patients who are undergoing bariatric surgery:
1. All cause and cause specific mortality over a mean of 10 years since bariatric surgery.
2. Incidence of cardiovascular disease, cancer and diagnosis of diabetes over a mean of 10 years since bariatric surgery
3. Incidence of acute and chronic postoperative complications. Acute complications, defined as up to three months post surgery, will include surgical site infection; chronic complications will include revisional surgery, plastic surgery and chronic pain.
4. Change in health related quality of life, anxiety and depression over time pre- and post-operatively for a mean of 10 years from date of bariatric surgery.
5. The micronutrient and weight status pre and post-operatively for a mean of 10 years since bariatric surgery.
6. The glycaemic control, lipids, blood pressure, medication prescription, and rate of diabetes complications (microalbuminuria and renal disease, retinopathy and foot ulceration) in those that have pre-existing diabetes or develop diabetes during a mean of 10 years follow up since bariatric surgery.
More details can be found at http://www.nets.nihr.ac.uk/projects/hta/104202
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/55413/PRO-10-42-02.pdf
Ethics approval
To be submitted to West of Scotland Reserach Ethics Commitee
Study design
Multi-centre prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
Bariatric surgery (surgical procedures developed for the primary purpose of weight loss currently laparoscopic gastric banding, sleeve gastrectomy and roux-en-y gastric bypass)
2000 patients undergoing bariatric surgery in the NHS and private sector in Scotland, UK, over a 5-year period will be recruited. The participants will be followed up for a mean of 10 years. The mortality, weight, incident type 2 diabetes mellitus (T2DM), coronary heart disease (CHD), cardiovascular disease (CVD), cancer, fractures, nutritional blood markers, anxiety, depression, post-operative complications, revisional surgery rates, health related quality of life, glycaemic control, diabetic complications and diabetes medications will be recorded.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
10-year mortality
Secondary outcome measures
In the 10 years following bariatric surgery:
1. Change in weight / body mass index (BMI) from pre-bariatric surgery weight
2. Rate of incident type 2 diabetes
3. Incidence of fatal and non-fatal coronary heart disease, cardiovascular disease, cancer and fractures
4. Incidence of incidence of nutritional deficiencies
5. Change in incidence of depression and anxiety compared to baseline level pre-operatively
6. Incidence of complications immediately post-operatively and the need for readmission for revisional procedures
7. Change in health-related quality of life compared to baseline level pre-operatively
8. Change in glycaemic control, cardiovascular risk factors, chronic kidney disease (CKD), retinopathy and medications prescribed in patients with diabetes compared to equally obese patient with diabetes who did not have bariatric surgery
9. Cost of the procedure and follow-up (to inform cost-effectiveness analysis)
Overall trial start date
01/01/2014
Overall trial end date
01/07/2026
Reason abandoned
Eligibility
Participant inclusion criteria
Undergoing bariatric surgery in NHS secondary care and private practice in Scotland, UK
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2014
Recruitment end date
01/01/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
BHF Cardiovascular Research Centre
Glasgow
G12 9PP
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde (UK)
Sponsor details
The Tennent Institute
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
-
Maureen.travers@ggc.scot.nhs.uk
Sponsor type
Government
Website
http://www.nhsggc.org.uk/content/default.asp?page=home_Research%20Development
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK) (10/42/02)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/05/2027
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary