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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

Tracking Information
First Submitted Date February 14, 2023
First Posted Date February 24, 2023
Last Update Posted Date December 8, 2023
Actual Study Start Date March 28, 2023
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2023)		 Long-term weight loss [ Time Frame: 10-15 years after surgery ]
Total weight loss after bariatric surgery
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 14, 2023)
  • Remission of comorbidities after bariatric surgery [ Time Frame: 10-15 years after surgery ]
    Remission of Type 2 Diabetes Mellitus, Hypertension and Sleep Apnoe
  • Quality of life after bariatric surgery [ Time Frame: 10-15 years after surgery ]
    Health related quality of life, SF -36
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bariatric Surgery Observation Study Part 2
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Bariatric Surgery Candidate
Intervention Procedure: Bariatric surgery
JDF11 JDF41 JDF97
Other Names:
  • Roux-en-Y gastsric bypass
  • Sleeve gastrectomy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 14, 2023)		 1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2027
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jorunn Sandvik, PhD +47977340 jorunn.sandvik@stolav.no
Contact: Siren Nymo, PhD +4799514188 siren.nymo@helse-nordtrondelag.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT05743166
Other Study ID Numbers StOlavsH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party St. Olavs Hospital
Original Responsible Party Jorunn Sandvik, St. Olavs Hospital, Consultant,
Current Study Sponsor St. Olavs Hospital
Original Study Sponsor Same as current
Collaborators
  • Helse Nord-Trøndelag HF
  • Helse Møre og Romsdal HF
Investigators
Principal Investigator: Jorunn Sandvik, PhD St. Olavs Hospital
PRS Account St. Olavs Hospital
Verification Date December 2023