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Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery (BAREVAL)

Primary Purpose

Obesity, Morbid, Bariatric Surgery Candidate

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bariatric surgery
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity, Morbid focused on measuring weight loss, sleeve gastrectomy, gastric bypass, gastric banding, bariatric procedures, cohort, morbid obesity, medical and economical impact, severe obesity

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery
  • Patients treated by bariatric surgery on CHU Montpellier
  • Agreed to participate to the study by signing an informed consent
  • Eligible to health insurance

Exclusion Criteria:

  • Unable to follow the patient in the long term (foreign patients, surgical use ...)
  • Inability to follow in the long run

Sites / Locations

  • CHRU - Hôpital Saint EloiRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Group/Cohort

Arm Description

all of the current bariatric surgeries are allowed in this prospective cohort study

Outcomes

Primary Outcome Measures

Assessment of the long-term efficiency of bariatric surgery on weight loss
Assessment of weight loss

Secondary Outcome Measures

Assessment of the long-term efficiency of bariatric surgery on diabetes
Assessment of blood glucose, HbA1c and diabetes medications
Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure
Assessment of Systolic Blood Pressure and blood pressure medications
Assessment of the long-term efficiency of bariatric surgery on dyslipidemia
Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications
Assessment of the long-term efficiency of bariatric surgery on rheumatism
Assessment of rheumatism medications
Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies
Assessment of respiratory pathologies medications
Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome
polysomnography tests
Assessment of the long-term efficiency of bariatric surgery on quality of life
Assessment of quality of life questionnaires (SF36 and BAROS)
Assessment of medico-economic impact of bariatric surgery
Comparison of health insurance data
Assessment of mortality of bariatric surgery
Assessment of the date of death

Full Information

First Posted
October 28, 2014
Last Updated
January 7, 2020
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02310178
Brief Title
Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery
Acronym
BAREVAL
Official Title
Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2012 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.
Detailed Description
The main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. Moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. From a methodological point of view, the Obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. The number of inclusions is to 1500 patients. After surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. The recommendations of the french health ministry (HAS), the frequency of visits may be increased according to the patient's progress. Follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . It will be insured for life, obesity is a chronic disease and because of the risk of late complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Bariatric Surgery Candidate
Keywords
weight loss, sleeve gastrectomy, gastric bypass, gastric banding, bariatric procedures, cohort, morbid obesity, medical and economical impact, severe obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group/Cohort
Arm Type
Other
Arm Description
all of the current bariatric surgeries are allowed in this prospective cohort study
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
all of the current bariatric surgeries are allowed in this prospective cohort study
Primary Outcome Measure Information:
Title
Assessment of the long-term efficiency of bariatric surgery on weight loss
Description
Assessment of weight loss
Time Frame
Change from intervention to 5 years
Secondary Outcome Measure Information:
Title
Assessment of the long-term efficiency of bariatric surgery on diabetes
Description
Assessment of blood glucose, HbA1c and diabetes medications
Time Frame
Change from intervention to 5 years
Title
Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure
Description
Assessment of Systolic Blood Pressure and blood pressure medications
Time Frame
Change from intervention to 5 years
Title
Assessment of the long-term efficiency of bariatric surgery on dyslipidemia
Description
Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications
Time Frame
Change from intervention to 5 years
Title
Assessment of the long-term efficiency of bariatric surgery on rheumatism
Description
Assessment of rheumatism medications
Time Frame
Change from intervention to 5 years
Title
Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies
Description
Assessment of respiratory pathologies medications
Time Frame
Change from intervention to 5 years
Title
Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome
Description
polysomnography tests
Time Frame
Change from intervention to 3 months
Title
Assessment of the long-term efficiency of bariatric surgery on quality of life
Description
Assessment of quality of life questionnaires (SF36 and BAROS)
Time Frame
Change from intervention to 5 years
Title
Assessment of medico-economic impact of bariatric surgery
Description
Comparison of health insurance data
Time Frame
Change from intervention to 5 years
Title
Assessment of mortality of bariatric surgery
Description
Assessment of the date of death
Time Frame
Change from intervention to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery Patients treated by bariatric surgery on CHU Montpellier Agreed to participate to the study by signing an informed consent Eligible to health insurance Exclusion Criteria: Unable to follow the patient in the long term (foreign patients, surgical use ...) Inability to follow in the long run
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David NOCCA, PUPH
Phone
0467337731
Ext
+33
Email
d-nocca@chu-montpellier.fr
Facility Information:
Facility Name
CHRU - Hôpital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David NOCCA, PUPH
Phone
0467337731
Ext
+33
Email
d-nocca@chu-montpellier.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
35524904
Citation
Nocca D, Galtier F, Taleb S, Picot MC, Jaussent A, Silvestri M, Lefebvre P, de Jong A, Gautier T, Loureiro M, Nedelcu M. Peri-operative Morbidity of Nissen Sleeve Gastrectomy: Prospective Evaluation of a Cohort of 365 Patients, Beyond the Learning Curve. Obes Surg. 2022 Jul;32(7):1-7. doi: 10.1007/s11695-022-06066-0. Epub 2022 May 7.
Results Reference
derived

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Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery

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