What groups of people are more prone to complications after Bariatric Surgery, and does acid suppression in the stomach play a role? A mulitregister study

• Register: ISRCTN
• Last refreshed on: 4 May 2020
• Main ID: ISRCTN12963684
• Date of registration: 04/11/2016
• Prospective Registration: No
• Primary sponsor: County Council of Västerbotten (Västerbottens läns landsting)
• Public title: What groups of people are more prone to complications after Bariatric Surgery, and does acid suppression in the stomach play a role? A mulitregister study
• Scientific title: Which sub-groups of people are more prone to complications after complications after Bariatric Surgery, and does post-operative prophylaxis with proton-pump inhibition play a role? A multiregister study
• Date of first enrolment: 31/10/2016
• Target sample size: 39000
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12963684
• Study type: Observational
• Study design: Single-site observational cohort study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Ulf Gunnarsson

• Name: Jeff Wennerlund

Key inclusion & exclusion criteria

Inclusion criteria: Patients eligible and accepted for primary laparoscopic gastric bypass surgery in Sweden during 2009-2014, and registered in the Scandinavian Obesity Surgery Registry (SOReg).
Exclusion criteria: Participants that do not fulfill inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Morbid obesity
Nutritional, Metabolic, Endocrine
Morbid obesity

Intervention(s)

Patient specific gender, age, BMI, existing co-morbidities, socio-economic status, and the presence of proton-pump inhibition is to be collected and compared with the occurrence of post-operative complications in a longitudinal multi-variate study .

After collecting data from the three registers, statistical analyses will be made focusing on the outcome of post-operative complications and their severity (according to the Clavien-Dindo scale) and necessary interventions, if any. Logistic regression models will be used in multi-variate analyses to pinpoint those factors (patient specific age, gender, BMI, pre-existing health problems, occurrence of proton-pump inhibition prophylaxis, and socioeconomic factors) that are associated with higher rates of complications, both as a total rate and for each individual complication. The rate of complications are also controlled against the Drug Registry if the prophylaxis was actually retrieved, or if therapy was prescribed and retrieved for other reasons.

Primary Outcome(s)

Identification of sub-groups according to age, gender, body mass index measured in body weight (kg)/ body length (m) squared, and pre-existing health problems at baseline that have less post-operative complications and severity thereof (according to the Clavien-Dindo scale) due to prophylaxis with proton-pump inhibition, measured at 30 days and at 1 and 2 years post-operatively.

Secondary Outcome(s)

Identification of socioeconomic factors at baseline that impact related health problems, the rate of post-operative complications, and occurrence and adherence to proton-pump prophylaxis.

Secondary ID(s)

PPI-GBP 001

Source(s) of Monetary Support

County Council of Västerbotten (Västerbottens läns landsting), Umeå Universitet

Ethics review

Status:
Approval date:
Contact:

Regional Ethics Committee of Umeå 12/1/2016. Case number 2015/367-31

Results

• Results available: Yes
• Date Completed: 31/05/2017