Generated Narrative: ResearchStudy

url: https://fevir.net/resources/ResearchStudy/208285

identifier: FEvIR Object Identifier/208285, REK project number/2010/2329

name: Year_2018_Norwegian_Cohort_Study

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

label

type: Official title (Title Type#official)

value: The Long-Term Effect of Treatment of Morbid Obesity

label

type: LETMO (Title Type#acronym "Acronym")

label

type: Short title (Title Type#short-title)

value: LETMO - a cohort study

relatedArtifact

type: specification-of

label: Protocol

display: eAppendix 2. Research Protocol

document

relatedArtifact

type: derived-from

resourceReference: Citation/104116: JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort

status: active

studyDesign: Observational research (sevco#SEVCO:01002), Parallel cohort design (sevco#SEVCO:01011), Longitudinal data collection (sevco#SEVCO:01028)

condition: morbid obesity ()

region: Norway ()

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.

period: 2010-07 --> 2015

site: : Vestfold Hospital Trust

associatedParty

name: 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.

role: Project Leader and Main Supervisor (Research Study Party Role#primary-investigator "primary-investigator")

associatedParty

name: 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

role: PhD Candidate (Research Study Party Role#collaborator "collaborator")

associatedParty

name: Jens Kristoffer Hertel, PhD, the Morbid Obesity Center, Vestfold Hospital Trust.

role: Co-supervisor (Research Study Party Role#collaborator "collaborator")

associatedParty

name: Arild Nesbakken, Professor, the Surgical Clinic, Oslo University Hospital

role: Co-supervisor (Research Study Party Role#collaborator "collaborator")

associatedParty

name: Rune Sandbu, dr.med, the Morbid Obesity Center and Department of Surgery, Vestfold Hospital Trust.

role: Co-supervisor (Research Study Party Role#collaborator "collaborator")

associatedParty

name: Milada Cvancarova Småstuen, PhD, the Morbid Obesity Center, South-Eastern Norway Regional Health Authority, Vestfold Hospital Trust

role: Biostatistician (Research Study Party Role#collaborator "collaborator")

ProgressStatuses

Recruitments

comparisonGroup

name: Bariatric Surgery

observedGroup: Group/172934: ExposureGroup: JAMA 2018 Norwegian cohort study Surgery cohort "ExposureGroup_JAMA_2018_Norwegian_cohort_study_Surgery_cohort"

comparisonGroup

description: Medical Obesity Treatment

observedGroup: Group/172939: ComparatorGroup: JAMA 2018 Norwegian cohort study Control cohort "ComparatorGroup_JAMA_2018_Norwegian_cohort_study_Control_cohort"

outcomeMeasure

name: Remission of diabetes

reference: EvidenceVariable/104117: OutcomeVariable: Remission of diabetes "OutcomeVariable_Remission_of_diabetes"

outcomeMeasure

name: New onset depression

reference: EvidenceVariable/104118: OutcomeVariable: New onset depression "OutcomeVariable_New_onset_depression"

outcomeMeasure

name: Treatment with opioids

reference: EvidenceVariable/104119: OutcomeVariable: Treatment with opioids "OutcomeVariable_Treatment_with_opioids"

outcomeMeasure

name: Additional GI surgical procedure

reference: EvidenceVariable/104120: OutcomeVariable: Additional GI surgical procedure "OutcomeVariable_Additional_GI_surgical_procedure"

result:

• Citation/104116: JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort
• Composition/178426: ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)