NCT05743166

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
687

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

February 14, 2023

Last Update Submit

May 27, 2026

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

  • Long-term weight loss

    Total weight loss after bariatric surgery

    10-15 years after surgery

Secondary Outcomes (2)

  • Remission of comorbidities after bariatric surgery

    10-15 years after surgery

  • Quality of life after bariatric surgery

    10-15 years after surgery

Interventions

Bariatric surgeryPROCEDURE

JDF11 JDF41 JDF97

Also known as: Roux-en-Y gastsric bypass, Sleeve gastrectomy

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015

You may not qualify if:

  • Not able to consent for participation
  • Includable participants not longer living in Norway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Helse Møre og Romsdal

Ålesund, 6017, Norway

Location

Helse Nord-Trondelag

Namsos, 7800, Norway

Location

St. Olavs Univeristy Hospital

Trondheim, 7030, Norway

Location

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Jorunn Sandvik, PhD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 24, 2023

Study Start

March 28, 2023

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)