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Clinical Trials/NCT05743166
NCT05743166
Recruiting
Not Applicable

Bariatric Surgery Observation Study Part 2 An Observational Study of Patients Who Underwent Bartiatric Surgery in Public Hospitals in Central Norway 2010-2015.

St. Olavs Hospital3 sites in 1 country1,000 target enrollmentMarch 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
St. Olavs Hospital
Enrollment
1000
Locations
3
Primary Endpoint
Long-term weight loss
Status
Recruiting
Last Updated
11 months ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2023
End Date
December 31, 2027
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Long-term weight loss

Time Frame: 10-15 years after surgery

Total weight loss after bariatric surgery

Secondary Outcomes

  • Remission of comorbidities after bariatric surgery(10-15 years after surgery)
  • Quality of life after bariatric surgery(10-15 years after surgery)

Study Sites (3)

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