Bariatric Surgery Observation Study Part 2

Bariatric Surgery Candidate Clinical Trial

— BAROBS2  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743166
• Other study ID #: StOlavsH
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: St. Olavs Hospital
• Contact: Jorunn Sandvik, PhD
• Phone: +47977340
• Email: jorunn.sandvik[@]stolav.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• Bariatric surgery
JDF11 JDF41 JDF97

Locations

Country	Name	City	State
Norway	Helse Møre og Romsdal	Ålesund
Norway	Helse Nord-Trondelag	Namsos
Norway	St. Olavs Univeristy Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Helse Møre og Romsdal HF, Helse Nord-Trøndelag HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term weight loss	Total weight loss after bariatric surgery	10-15 years after surgery
Secondary	Remission of comorbidities after bariatric surgery	Remission of Type 2 Diabetes Mellitus, Hypertension and Sleep Apnoe	10-15 years after surgery
Secondary	Quality of life after bariatric surgery	Health related quality of life, SF -36	10-15 years after surgery