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Bariatric Surgery Observation Study Part 2 (BAROBS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05743166
Recruitment Status : Recruiting
First Posted : February 24, 2023
Last Update Posted : December 8, 2023
Sponsor:
Collaborators:
Helse Nord-Trøndelag HF
Helse Møre og Romsdal HF
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
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Brief Summary:

The goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years

The main question[s] it aims to answer are:

  • The duration of the surgical method on weight reduction and remission of comorbidities

  • Theprevalence of complications and new morbidities after the surgical procedures Participants will be asked be asked to

    • fill inn questionnaires,
    • have a clinical examinition
    • have an interview with nurse and doctor
    • have blood samples taken
    • undergo other investigations

Condition or disease Intervention/treatment
Bariatric Surgery Candidate Procedure: Bariatric surgery

Detailed Description:

The BAROBS project is a collaberation between three public hospitals in Norway exploring the concequeces ten years or more after undergoing gastric bypass or sleeve gastrectomy for severe obesity.

1400 patients who underwent bariatric surgery at the three hospitals will be invited to a follow up including antrophometric, meassurment of bodily composition by bioimpedance and DXA, blood samples, questionnaires on sosioeconomic topics, symptoms and quality of life, continous glucose monitoring, dental examination, and other clinical evaluation.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Bariatric Surgery Observation Study Part 2 An Observational Study of Patients Who Underwent Bartiatric Surgery in Public Hospitals in Central Norway 2010-2015.
Actual Study Start Date : March 28, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Bariatric surgery
    JDF11 JDF41 JDF97
    Other Names:
    • Roux-en-Y gastsric bypass
    • Sleeve gastrectomy

Outcome Measures
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Primary Outcome Measures :
  1. Long-term weight loss [ Time Frame: 10-15 years after surgery ]
    Total weight loss after bariatric surgery


Secondary Outcome Measures :
  1. Remission of comorbidities after bariatric surgery [ Time Frame: 10-15 years after surgery ]
    Remission of Type 2 Diabetes Mellitus, Hypertension and Sleep Apnoe

  2. Quality of life after bariatric surgery [ Time Frame: 10-15 years after surgery ]
    Health related quality of life, SF -36


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1400 patients who had baratric surgery at three public hospitals in Central Norway from 2010 to 2015 are invited to a follow up in 2023-2025
Criteria

Inclusion Criteria:

  • Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015

Exclusion Criteria:

  • Not able to consent for participation
  • Includable participants not longer living in Norway
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05743166


Contacts
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Contact: Jorunn Sandvik, PhD +47977340 jorunn.sandvik@stolav.no
Contact: Siren Nymo, PhD +4799514188 siren.nymo@helse-nordtrondelag.no

Locations
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Norway
Helse Nord-Trondelag Recruiting
Namsos, Norway, 7800
Contact: Siren Nymo, PhD    +4799514188    siren.nymo@helse-nordtrondelag.no   
Contact: Hallvard Græslie, MD    +4791376579    hallvard.greslie@helse-nordtrondelag.no   
St. Olavs Univeristy Hospital Recruiting
Trondheim, Norway, 7030
Contact: Jorunn Sandvik, PhD    +4797734018    jorunn.sandvik@stolav.no   
Contact: Åsne Ask Hyldmo, MD    +4747378717    asne.ask.hyldmo@stolav.no   
Helse Møre og Romsdal Recruiting
Ålesund, Norway, 6017
Contact: Jorunn Sandvik, PhD    +4997734018    jorunn.sandvik@stolav.no   
Contact: Kirsti Kverndokk Bjerkan, MSc    +4792400081    kirsti.kverndokk.bjerkan@helse-mr.no   
Sponsors and Collaborators
St. Olavs Hospital
Helse Nord-Trøndelag HF
Helse Møre og Romsdal HF
Investigators
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Principal Investigator: Jorunn Sandvik, PhD St. Olavs Hospital
More Information
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT05743166    
Other Study ID Numbers: StOlavsH
First Posted: February 24, 2023    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No