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Between 2020 and 2022, there was a considerable reduction in bariatric surgery procedures, in order to prioritize other interventions.
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An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. To design a large randomized clinical trial (RCT) comparing teleevaluations and teleconsultations to classical follow, aiming to prove that the quality of the follow-up is maintained and the patient-experience is improved, at a lower cost in people living far from the reference centre, this pilot study aims at describing the distribution of the collected criteria.
An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. This follow-up requires about 5 multi-professional evaluations during the first year. This can be cumbersome in patients living far from the reference centre and who may perceive the necessary time, cost and lost of income, and constraints as imbalanced. Teleevaluations and teleconsultations may solve this issue by replacing some of the classical evaluations (at 6 and 9 months). An RCT would be necessary, and a pilot study is proposed to describe the distribution of the judgment criteria.
This pilot study aims at describing all the parameters necessary to build an RCT, and involves the randomisation of operated patients recruited 3 months after surgery, in to groups. One will have the classical follow-up (venue and consultations at 6 and 9 months) the over will have teleevaluations and teleconsultations ; the parameters will be described at 12 months. The teleevaluation is either proposed as usual (a file is sent by secure mail) or by chatbot interaction. The consultation and the teleconsultation are based on the standard of care scenario.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Patients in the teleconsultation arm will benefit from a tele-evaluation (a questionnaire filled through a chatbot link) and teleconsultation (skype-like connection) at 6 and 9 months after surgery. |
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| Control | Experimental | Patients in the consultation arm will benefit from a tele-evaluation (a questionnaire filled at home after the file was sent by secured mail) and a classical face to face consultation at 6 and 9 months after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleevaluation | Other | Patients will answer to a questionnaire filled through a chatbot link |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite score research | Look for the composite follow-up quality score taking into account weighting results, co-morbidities, absence of complications and skill acquisition. | month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient evaluation | Coefficient of variation and Cronbach's coefficient assessing the quality of the composite follow-up quality score | month 12 |
| Consultation measure | the time of a teleconsultation and a face-to-face consultation, by an objective measurement of this time at 6 and 9 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick RITZ, Md | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ritz | Toulouse | Toulouse | 31000 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019114 | Remote Consultation |
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Teleconsultation | Other | A teleconsultation (skype-like connection) at 6 and 9 months after surgery |
|
| Classical consultation | Other | Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery. |
|
| month 6 and 9 |
| Composite distribution | the distribution of each of the components of the Composite Follow-up Quality Score in the two arms of the study | month 12 |
| Consultation feeling | satisfaction and constraints felt with regard to teleconsultations, by scores measured at teleconsultations and consultation at 6 and 9 months post-operatively | Month 6 and 9 |
| Consultation feasability | the feasibility of teleconsultation and consultation with scores measured at 6 and 9 months post-operatively | month 6 and 9 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |