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Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.
Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemiosphere® BALLOON | Active Comparator | Balloon filled with air according to the manufacturing company orders 600 or 720 ml air |
|
| Fluid filled balloon | Active Comparator | Balloon filled with saline and methylene blue according to the manufacturing company orders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air filled balloon | Device | Balloon filled with air according to the manufacturing company orders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight loss by Kg and BMI, | 6 months |
| Rate of deflation or puncture | Rate of deflation or puncture (in air filled, it well be followed up by x ray every 2 weeks while in saline filled, it well be followed up by observation of blue coloured urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mohamed e abd ellatif, PhD | Contact | 0543973660 |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed E Abd Ellatif, PhD | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hafr Albatin Central hospital | Recruiting | Mansoura University | Egypt |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Bioenteric BIB® balloon | Device | Balloon filled with saline and methylene blue according to the manufacturing company orders |
|
|
| 6 MONTHS |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |