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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Balloon filled with air according to the manufacturing company orders
Balloon filled with saline and methylene blue according to the manufacturing company orders
Hafr Albatin Central hospital
Mansoura University, Egypt
RECRUITINGTolerance
Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia
Time frame: 6 months
Weight loss
Weight loss by Kg and BMI,
Time frame: 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
Time frame: 6 MONTHS
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