BAROBS2: Bariatric Surgery Observation Study Part 2

Sponsor

St. Olavs Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05743166

Collaborator

Helse Nord-Trøndelag HF (Other), Helse Møre og Romsdal HF (Other)

1,000

Enrollment

Locations

Anticipated Duration (Months)

333.3

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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.

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

Long-term weight loss [10-15 years after surgery]
Total weight loss after bariatric surgery

Secondary Outcome Measures

Remission of comorbidities after bariatric surgery [10-15 years after surgery]
Remission of Type 2 Diabetes Mellitus, Hypertension and Sleep Apnoe
Quality of life after bariatric surgery [10-15 years after surgery]
Health related quality of life, SF -36

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Helse Nord-Trondelag	Namsos	Norway	7800
2	St. Olavs Univeristy Hospital	Trondheim	Norway	7030
3	Helse Møre og Romsdal	Ålesund	Norway	6017

Sponsors and Collaborators

St. Olavs Hospital
Helse Nord-Trøndelag HF
Helse Møre og Romsdal HF

Investigators

Principal Investigator: Jorunn Sandvik, PhD, St. Olavs Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jorunn Sandvik, Consultant,, St. Olavs Hospital

ClinicalTrials.gov Identifier:

NCT05743166

Other Study ID Numbers:

StOlavsH

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 24, 2023