Bariatric Surgery Observation Study Part 2

Recruiting

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT05743166
• Lead Sponsor: St. Olavs Hospital

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 Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Study Start: 2023-03-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term weight loss	10-15 years after surgery	Total weight loss after bariatric surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Helse Nord-Trondelag; 🇳🇴 Namsos, Norway

Helse Møre og Romsdal; 🇳🇴 Ålesund, Norway

St. Olavs Univeristy Hospital; 🇳🇴 Trondheim, Norway