Bariatric Surgery on the West Coast of Norway (Vestlandet) (FatWest)

Helse Fonna

Status: Unknown

Conditions: Weight Loss; Diabetes Mellitus; Urinary Incontinence

Treatments: Procedure: Bariatric surgery

Study type: Observational

Funder types: Other

Identifiers

NCT01533142

2010/3287

Details and patient eligibility

About

Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods.

This project is part of the regional strategic research initiative in the Helse Vest

Full description

Primary endpoints for the study are weight loss and self-reported quality of life (QoL) evaluated by Short Form (SF)-36 and Impact of Weight Wed Quality of Life-Lite (IWQOL-Lite)) Our hypothesis is that patients operated with RYGBP (Roux A-Y Gastric Bypass) and BPD / DS (biliopancreatic diversion with duodenal switch) have the same weight and same QoL after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (LSG)) We will also compare the groups with respect to a number of secondary endpoints

400 patients (approximately 100 patients / institution) will be included in the main study. Some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. These studies will be reported in separate articles.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both sexes 18-60 years old
• Patients with morbid obesity that is applied to the bariatric surgery.
• Signed informed consent

Exclusion criteria

• Patients who become pregnant in the follow-up period will not continue in the study but the data will be treated as lost too follow up.

Trial design

400 participants in 2 patient groups

surgical methods

Description:

Different methods are used among hospitals in Helse-Vest, and this allows us to compare different clinical and biological effects following bariatric surgery different methods) among a homogeneous population in the western part of Norway (Vestlandet

Treatment:

Procedure: Bariatric surgery

Procedure: Bariatric surgery

Morbid obesity

Treatment:

Procedure: Bariatric surgery

Procedure: Bariatric surgery