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

February 17, 2016 updated by: Bjørn Gunnar Nedrebø, MD, PhD, Helse Fonna

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Per Espen Hovde-Hansen, MD
  • Phone Number: ?47 52732000

Study Locations

  • Norway
      • Haugesund, Norway, 5528
        • Recruiting
        • Helse-Fonna
        • Contact:
        • Contact:
          • Per Espen Hovde-Hansen, MD
          • Phone Number: +475273200
        • Principal Investigator:
          • Bjorn Gunnar Nedrebo, MD, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
surgical methods
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
Procedure: Bariatric surgery

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

sleeve gastrectomy or gastric bypass

Procedure: Bariatric surgery
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
Morbid obesity
Procedure: Bariatric surgery

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

sleeve gastrectomy or gastric bypass

Procedure: Bariatric surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: From 1 year and up to 5 years
From 1 year and up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
remission of diabetes mellitus type 2
Time Frame: from 1 year up to 5 years
from 1 year up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Fonna

Collaborators

Helse Forde
Helse-Bergen HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 11, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/3287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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