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Completed

NCT Number: NCT01533142

Bariatric Surgery on the West Coast of Norway (Vestlandet)

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

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Lower Urinary Tract Symptoms Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helse-Fonna

Haugesund, 5528, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

Procedure

Patients will be treated with one of two bariatric procedure::

sleeve gastrectomy or gastric bypass

Primary outcomes

  1. weight loss

    Time frame: From 1 year and up to 5 years

Secondary outcomes

  1. remission of diabetes mellitus type 2

    Time frame: from 1 year up to 5 years

Sponsors and collaborators

Lead sponsor

Helse Fonna

Other

Collaborators

  • Helse Forde
  • Helse-Bergen HF

Registry information

Official study title

Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery

Acronym: FatWest

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2012
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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