Title: Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities

Name: 2018 Norwegian Cohort Study

Official title (coded as: official from http://hl7.org/fhir/title-type): The Long-Term Effect of Treatment of Morbid Obesity

Acronym (coded as: acronym from http://hl7.org/fhir/title-type); LETMO:

Short title (coded as: short-title from http://hl7.org/fhir/title-type): LETMO - a cohort study

Identifier: FOI 208285

Identifier: REK project number identifier 2010/2329

Study start and end: July 2010 to 2015

Progress Status: Completed (coded as: completed from http://hl7.org/fhir/research-study-status)( )

Description: The main purpose of this study is, in combination with data from the Register and Biobank study and follow-up data from the Norwegian Prescription Database, to compare the long-term effects (4-10 years) of surgical and non-surgical treatment of morbid obesity on obesity related comorbidities by studying changes in medicine usage after treatment. Hypotheses 1. Primary hypothesis: As compared to non-surgical treatment, bariatric surgery will be associated with higher rates of remission, and lower rates of new-onset drug treated hypertension during a follow-up period of ≤ 10 years. 2. Secondary hypotheses: Changes in the usage of other drugs, particularly drugs related to obesity related comorbidities, will differ significantly between patients undergoing bariatric surgery or non-surgical treatment during the follow-up period.

Condition: morbid obesity

Region: Norway (coded as: NO from urn:iso:std:iso:3166)

Study Design: Observational research (coded as: SEVCO:01002 from http://hl7.org/fhir/study-design)

Study Design: Parallel cohort design (coded as: SEVCO:01011 from http://hl7.org/fhir/study-design)

Study Design: Longitudinal data collection (coded as: SEVCO:01028 from http://hl7.org/fhir/study-design)

Related Item (specification-of): eAppendix 2. Research Protocol

Related Item (derived-from): JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort

Associated Party: Jøran Hjelmesæth, Leader of the Morbid Obesity Center, Vestfold Hospital Trust, and Professor at the Department for Endocrinology, Morbid Obesity and Preventitive Medicine, Medical Clinic, the Institute for Clinical Medicine, the University of Oslo. (primary-investigator (coded as: primary-investigator from http://hl7.org/fhir/research-study-party-role); Project Leader and Main Supervisor)

Associated Party: Gunn Signe Jakobsen, cand. med. at the Morbid Obesity Center, South-Eastern Norway Regional Health Authority. Doctor with a specialisation at the department for Gastroenterological Surgery, Akershus University Hospital. Mobil: 916 25 647, email: gunn.signe.jakobsen@siv.no (collaborator (coded as: collaborator from http://hl7.org/fhir/research-study-party-role); PhD Candidate)

Associated Party: Jens Kristoffer Hertel, PhD, the Morbid Obesity Center, Vestfold Hospital Trust. (collaborator (coded as: collaborator from http://hl7.org/fhir/research-study-party-role); Co-supervisor )

Associated Party: Arild Nesbakken, Professor, the Surgical Clinic, Oslo University Hospital (collaborator (coded as: collaborator from http://hl7.org/fhir/research-study-party-role); Co-supervisor)

Associated Party: Rune Sandbu, dr.med, the Morbid Obesity Center and Department of Surgery, Vestfold Hospital Trust. (collaborator (coded as: collaborator from http://hl7.org/fhir/research-study-party-role); Co-supervisor)

Associated Party: Milada Cvancarova Småstuen, PhD, the Morbid Obesity Center, South-Eastern Norway Regional Health Authority, Vestfold Hospital Trust (collaborator (coded as: collaborator from http://hl7.org/fhir/research-study-party-role); Biostatistician)

Site: Vestfold Hospital Trust

Target number of participants: 505

Actual number of participants: 1888

Enrollment Group: StudyGroup: Severely Obese Adults 2018 Norwegian Cohort

Comparison Group: Bariatric Surgery () ExposureGroup: JAMA 2018 Norwegian cohort study Surgery cohort

Comparison Group: Medical Obesity Treatment () ComparatorGroup: JAMA 2018 Norwegian cohort study Control cohort

Objective: Remission of diabetes () OutcomeVariable: Remission of diabetes

Objective: New onset depression () OutcomeVariable: New onset depression

Objective: Treatment with opioids () OutcomeVariable: Treatment with opioids

Objective: Additional GI surgical procedure () OutcomeVariable: Additional GI surgical procedure

Result: JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort

Result: Citation for Composition: ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)