Obesity
Conditions
Interventions
All the procedures described below were performed in 10 patients, without control group.
Gastric fundus embolization procedures were performed under local anesthesia and sedation with intravenous admi
Drug
Device
Procedure/surgery
Radiation
C23.888.144.243
E01.370.600.115.100
Sponsors
Hospital Federal de Bonsucesso
Universidade Federal do Rio de Janeiro
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Ten patients, females, over the age of 18 and under 50 years old; with a diagnosis of obesity grades 1 and 2 and Metabolic Syndrome .
Exclusion criteria
Exclusion criteria: Individuals weighing more than 180 kg; pregnant or wishing to become pregnant within the next six months; with history of gastric surgery, alcoholism or previous drug abuse; with coagulation disorder and presence of advanced heart, lung or liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical safety assessment of bariatric embolization through the absence of severe complications that require rehospitalization after discharge or new surgical interventions to treat it. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the change in ghrelin levels in pg / ml after the procedure until the sixth month;;Evaluation of weight loss in kg over the six months after the intervention;;Evaluation of the evolution of gastric symptoms before and up to six months after the intervention through the PADYQ questionnaire;;Evaluation of the evolution of binge eating symptoms before and up to six months after intervention through the periodic eating binge scale;;Evaluation of the evolution of the quality of life before and until six months after the intervention through the WHOQOL-BREF questionnaire;;Evaluation of changes in body composition 6 months after the procedure through bioimpedance;;Evaluation of changes in blood pressure levels in mmHg, serum lipids in mg / dL and fasting glucose after the intervention for a period of six months. | — |
Countries
Brazil
Contacts
Public ContactRaphael Levigard
Hospital Federal de Bonsucesso
Outcome results
None listed