Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bariatric Surgery
  • Long Term Follow-Up
  • Weight Regain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multi-centre, randomised, open, controlled studyMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Bariatric surgery is developing rapidly. In France, the number of annual interventions increased threefold between 2001 and 2015, from 16,000 to 50,000 per year. This rapid development is explained by the well-demonstrated benefits of surgery: spectacular improvement in the quality of life, reductio...

Bariatric surgery is developing rapidly. In France, the number of annual interventions increased threefold between 2001 and 2015, from 16,000 to 50,000 per year. This rapid development is explained by the well-demonstrated benefits of surgery: spectacular improvement in the quality of life, reduction in co-morbidities (diabetes, cardiovascular diseases, and steatohepatitis), and significant reduction in mortality linked to severe obesity. However, the benefits of surgery may decrease over time and may be associated with side effects. Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation. The current recommendations therefore do not seem adapted to clinical reality. They do not prevent the regain of weight in many patients, which frequently leads to re-operations. Even more worrying is the possible occurrence of late complications, sometimes serious and life-threatening. This study will assess a new care pathway in which the patients are follow-up according to weight evolution measured by the patient using a connected scale.

Tracking Information

NCT #
NCT04639778
Collaborators
Ministry of Health, France
Investigators
Principal Investigator: François Pattou, MD,PhD University Hospital, Lille