Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons in the Treatment of Obesity
- Conditions
- ObesityMetabolic Syndrome
- Interventions
- Device: Air-filled Intragastric balloon
- Registration Number
- NCT03102697
- Lead Sponsor
- Kaiser Clinic and Hospital
- Brief Summary
This is a cohort study with the objective of describing during a 12-month follow-up, weight loss in obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.
- Detailed Description
Intragastric balloon (IGB) implantation is a widely used technique to treat overweight subjects and those with mild obesity. The effectiveness of the air filled balloon (Heliosphere BAG®) in improving weight loss, reduction of BMI, percentage of body weight loss, percentage of excess weight loss and complications six months after placement is notable. Several methods are available for IGB placement and new techniques are being developed to reduce discomfort during and after the procedure. Thus, the use of an IGB as an effective method to avoid bariatric surgery is proposed. However, the precise protocol to balance complications and discomfort while maximizing weight loss is still to be established.
Our secondary objectives will be:
* Describe the weight loss, changes in the BMI and excess weight loss between the implantation of the first IGB until its removal;
* Describe changes in the components of the metabolic syndrome;
* Describe changes in blood pressure;
* Estimate the rate of early explant;
* Describe the conditions of surgery;
* Describe operative complications;
* To describe safety in the perioperative period, in the immediate postoperative period and in the late postoperative period
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2).
- Morbid obesity (BMI>40kg/m2), operative contraindications.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obese individuals Air-filled Intragastric balloon Obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.
- Primary Outcome Measures
Name Time Method Weight loss 12 months Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI
- Secondary Outcome Measures
Name Time Method Change in blood pressure 12 months Arterial blood pressure will be measured before and after IGB using an digital sphygmomanometer
Physical activity 12 months Physical activity will be self-reported on a weekly basis
Posoperative complications Through posToperative period completion, an average of 72 hours after the termination of surgery Rate of postoperative complications
Rate of early explant 12 months Rate of patients in which the balloon was extracted early
Operative complications Through endoscopy completion, an average of 2 hours Rate of complications during the placement of the balloon
Excess weight loss 12 months Measure that relates the preoperative weight, the postoperative weight and ideal weight
Changes Glycated hemoglobin (HbA1c) 12 months Blood measurements of Glycated hemoglobin (HbAq1c) will be reported in International Federation of Clinical Chemistry and Laboratory Medicine Units
Caloric intake 12 months Caloric intake will be self-reported on a weekly basis
Trial Locations
- Locations (1)
School of Medice of ABC
🇧🇷Santo Andre, Sao Paolo, Brazil