Bariatric Surgery Observation Study Part 2

NCT ID: NCT05743166

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-28

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Bariatric surgery

JDF11 JDF41 JDF97

Intervention Type PROCEDURE

Other Intervention Names

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Roux-en-Y gastsric bypass Sleeve gastrectomy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorunn Sandvik, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

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Helse Møre og Romsdal

Ålesund, , Norway

Site Status RECRUITING

Helse Nord-Trondelag

Namsos, , Norway

Site Status RECRUITING

St. Olavs Univeristy Hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Jorunn Sandvik, PhD

Role: CONTACT

+47977340

Siren Nymo, PhD

Role: CONTACT

+4799514188

Facility Contacts

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Jorunn Sandvik, PhD

Role: primary

+4997734018

Kirsti Kverndokk Bjerkan, MSc

Role: backup

+4792400081

Siren Nymo, PhD

Role: primary

+4799514188

Hallvard Græslie, MD

Role: backup

+4791376579

Jorunn Sandvik, PhD

Role: primary

+4797734018

Åsne Ask Hyldmo, MD

Role: backup

+4747378717

Other Identifiers

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StOlavsH

Identifier Type: -

Identifier Source: org_study_id

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