Morbid Obesity, Tolerance, Weight Loss
Conditions
Keywords
Morbid obesity, Gastric balloon, Weight loss, Tolerance, Safety
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAir filled balloon
Balloon filled with air according to the manufacturing company orders
DEVICEBioenteric BIB® balloon
Balloon filled with saline and methylene blue according to the manufacturing company orders
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Morbidly obese patients
Exclusion criteria
* Patient refused * Non compliant patients * Psychological patients * Oesophageal varices, big hiatus hernia, ulcers * Gastric vascular malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 6 months | Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 6 months | Weight loss by Kg and BMI, |
| Rate of deflation or puncture | 6 MONTHS | 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 |
Countries
Egypt
Contacts
Primary Contactmohamed e abd ellatif, PhD
Outcome results
None listed