Bariatric Surgery Observation Study Part 2

NCT05743166 | Recruiting

• 1 other identifier: StOlavsH
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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

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 surgery PROCEDURE

JDF11 JDF41 JDF97

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Helse Nord-Trøndelag HF: collaborator
• Helse Møre og Romsdal HF: collaborator

Study Sites (3)

Helse Møre og Romsdal

Ålesund, 6017, Norway

RECRUITING

Helse Nord-Trondelag

Namsos, 7800, Norway

RECRUITING

St. Olavs Univeristy Hospital

Trondheim, 7030, Norway

RECRUITING

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jorunn Sandvik, PhD

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorunn Sandvik, PhD

CONTACT

+47977340; jorunn.sandvik@stolav.no

Siren Nymo, PhD

CONTACT

+4799514188; siren.nymo@helse-nordtrondelag.no

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 (Estimated): December 31, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)