Bariatric Surgery on the West Coast of Norway (Vestlandet)

NCT ID: NCT01533142

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Brief Summary

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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

Detailed Description

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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.

Conditions

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Weight Loss Diabetes Mellitus Urinary Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Bariatric surgery

Intervention Type PROCEDURE

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

sleeve gastrectomy or gastric bypass

Bariatric surgery

Intervention Type PROCEDURE

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

Bariatric surgery

Intervention Type PROCEDURE

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

sleeve gastrectomy or gastric bypass

Bariatric surgery

Intervention Type PROCEDURE

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

Interventions

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Bariatric surgery

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

sleeve gastrectomy or gastric bypass

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Forde

OTHER

Sponsor Role collaborator

Helse-Bergen HF

OTHER

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role lead

Responsible Party

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Bjørn Gunnar Nedrebø, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helse-Fonna

Haugesund, Haugesund, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Bjorn Gunnar Nedrebo, MD,PhD

Role: CONTACT

+4792226845

Per Espen Hovde-Hansen, MD

Role: CONTACT

?47 52732000

Facility Contacts

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Bjorn Gunnar Nedrebo, MD, PhD

Role: primary

+4792226845

Per Espen Hovde-Hansen, MD

Role: backup

+475273200

References

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Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Matre K, Cramariuc D. Long-Term Trajectories of Left Heart Geometry, Mechanics, and Oxygen Demand After Bariatric Surgery. Circ Heart Fail. 2025 May;18(5):e012367. doi: 10.1161/CIRCHEARTFAILURE.124.012367. Epub 2025 Apr 7.

Reference Type DERIVED
PMID: 40190274 (View on PubMed)

Grymyr LMD, Mellgren G, McCann A, Gerdts E, Meyer K, Nadirpour S, Ferno J, Nedrebo BG, Cramariuc D. Preoperative risk factors associated with left ventricular dysfunction after bariatric surgery. Sci Rep. 2024 Jan 25;14(1):2173. doi: 10.1038/s41598-024-52623-1.

Reference Type DERIVED
PMID: 38273044 (View on PubMed)

Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Hjertaas JJ, Matre K, Cramariuc D. One-year impact of bariatric surgery on left ventricular mechanics: results from the prospective FatWest study. Eur Heart J Open. 2021 Aug 20;1(2):oeab024. doi: 10.1093/ehjopen/oeab024. eCollection 2021 Sep.

Reference Type DERIVED
PMID: 35919265 (View on PubMed)

Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Hjertaas JJ, Matre K, Cramariuc D. Left ventricular myocardial oxygen demand and subclinical dysfunction in patients with severe obesity referred for bariatric surgery. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):666-674. doi: 10.1016/j.numecd.2020.10.009. Epub 2020 Oct 17.

Reference Type DERIVED
PMID: 33257189 (View on PubMed)

Other Identifiers

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2010/3287

Identifier Type: -

Identifier Source: org_study_id

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