Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome
COLOSS
1 other identifier
observational
400
1 country
1
Brief Summary
It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
October 9, 2019
CompletedFirst Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedNovember 27, 2019
November 1, 2019
6.1 years
November 25, 2019
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypertension
The primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.
1 year
Study Arms (2)
Bariatric OSA Group
Bariatric surgery plannified intervention patient with obstructive sleep Apnéa
Bariatric without OSA Group
Bariatric surgery plannified intervention patient without obstructive sleep Apnéa
Interventions
Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)
Eligibility Criteria
Patient in preparation for bariatric surgery in the center CELIOBE
You may qualify if:
- Patient, male or female, aged over 18
- Patient in preparation for bariatric surgery (ring, Sleeve gastrectomy or Bypass) in the center CELIOBE.
- Patient affiliated with social security or beneficiary of such a scheme
- Patient having signed the free and informed consent
You may not qualify if:
- Patient who has already had bariatric surgery (ring, sleeve gastrectomy or bypass).
- Patient already receiving CPAP treatment for sleep apnea syndrome.
- Patients with pathology indicating the use of CPAP in self-guided mode (heart failure with altered ejection fraction) for patients diagnosed with OSAS
- Patient likely, in the opinion of the investigator, not to be cooperative or respectful of the obligations inherent to participation in the study
- Patient suffering from mental pathology does not make possible the collection of a consent.
- Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, lactating or parturient woman
- Patient hospitalized without consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- Dr CODRONcollaborator
Study Sites (1)
Hôpital privé La Louvière
Lille, Haut de France, 59800, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2019
First Posted
November 27, 2019
Study Start
October 9, 2019
Primary Completion
November 30, 2025
Study Completion (Estimated)
May 31, 2026
Last Updated
November 27, 2019
Record last verified: 2019-11