Bariatric Surgery Observation Study Part 2 | NCT05743166

Studies
Bariatric Surgery Observation Study Part 2

NCT05743166

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

May 29, 2026Actual

Enrollment

687Actual

Phase

Not provided

Conditions

Bariatric Surgery Candidate

Interventions

Bariatric surgery

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2023Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Mar 31, 2026Actual

First Submitted Date

Feb 14, 2023

First Submission Date that Met QC Criteria

Feb 14, 2023

First Posted Date

Feb 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2026

Last Update Posted Date

May 29, 2026Actual

Name	Class
Helse Nord-Trøndelag HF	OTHER
Helse Møre og Romsdal HF	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

687Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bariatric surgery	Procedure	JDF11 JDF41 JDF97		Roux-en-Y gastsric bypass Sleeve gastrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term weight loss	Total weight loss after bariatric surgery	10-15 years after surgery

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jorunn Sandvik, PhD	St. Olavs Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helse Møre og Romsdal		Ålesund		6017	Norway
Helse Nord-Trondelag

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

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