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. This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
390
Clinical visits conducted by a multidisciplinary team every year
Clinical visits are triggered by weight evolution measured by connected balance
Ch Boulogne-Sur-Mer - Boulogne Sur Mer
Boulogne-sur-Mer, France
RECRUITINGHop Claude Huriez Chu Lille
Lille, France
RECRUITINGEvaluate the efficacy of new care pathway
The main evaluation criterion is the success rate in terms of weight loss defined by an excess weight loss greater than 50%, in the absence undernutrition. Undernutrition is defined by a BMI \< 21 kg / m2 and / or an albumin level \<35 g /l
Time frame: 3 years
Cost-effectiveness of new care pathway
Cost-effectiveness of new care pathway
Time frame: 3 years
Number of visits made by the multidisciplinary team
Number of visits made by the multidisciplinary team
Time frame: 3 years
Number of postoperative surgical and / or medical complications
Number of postoperative surgical and / or medical complications that justified hospitalisation
Time frame: 3 years
Change of nutritional parameters in the blood of vitamines
Time frame: 3 years
Change of nutritional parameters in the blood of minerals
Time frame: 3 years
Change of nutritional parameters in the blood of protein
Time frame: 3 years
Dutch Eating Behavior Questionnaire (DEBQ)
Dutch Eating Behaviour Questionnaire (DEBQ) consists of 33 items and assesses on a 5-point Likert scale, ranging from "never" to "very often" external, restraint and emotional eating. For the study, only the 10 items of the external eating subscale will be used. The variable of interest will be the corresponding External eating subscale score.
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Time frame: 3 years
Frequency of Food Consumption Questionnaire
A food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120.
Time frame: 3 years
Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD)
Changes of anxiety and depression over three weeks training on a 4-point likert scale scored 0-3. Max 21 Points for each subscale, cut off for anxiety and Depression are set at 7 Points higher values represent more anxiety and Depression.
Time frame: 3 years
Ricci-Gagnon score
Evaluation of physical activity This score describe the physical profile : inactive, active, very active, at month 4 It is calculated by adding the number of points (1 to 5) corresponding to the box checked for each question. Less than 18=inactive Between 18 and 35=active More than 35=Active
Time frame: 3 years
Quality of life of SF36
Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
Time frame: 3 years
Quality of life of questionnaire EQ-5D-5L
The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale \[VAS\]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.
Time frame: 3 years