The Intragastric Balloon (IGB) has been used for more than 20 years in Brazil as an endoscopic method for assisting weight loss, and some intercurrences were observed during more than 10,000 procedures performed. One of these intercurrences is the presence of fungi in the IGB, increasing the friability of the silicone and inducing the premature rupture of the IGB, as well as gas hyperinflation.
Aims & Methods
To evaluate the effectiveness of the use of antifungal (Nystatin), diluted in intragastric balloon filling saline solution, in order to prevent the appearance of fungi in silicon,120 patients(76.7% women) who underwent adjustable intragastric balloon Spatz3 throughout the year 2017. Patients were divided into two groups by randomized clinical trial: 60 patients had 50 Nystatin milliliters (100,000 IU / ML) mixed with saline solution with Methylen Blue in the IGB filling and the other 60 patients had their IGB filled with saline solution and Methylene Blue. Only the nursing team knew which patients had received antifungals in the filling of the balloon (double-blind study). The initial volume of IGB filling in all patients was 700ml. Initial BMI started at 27 kg/m2 and IGB maximum period implant was 12 months. When the IGB was removed, the Endoscopist described whether there was fungal colonization on the silicone surface and, when there was, divided the colonization on the silicone surface in 4 stages: less than 10% (insignificant), between 10% and 25% (light), between 20 and 50% (moderate) and more than 50% (accentuated). When there was insignificant colonization (up to 10%) it was described as normal in the database.
19 patients (15.84%) were excluded from the final analysis: 2 (1.66%) due to early removal, 15 (12.5%) did volume adjustment during the IGB and 2 (1, 66%) balloon spontaneous deflation or leakage. Among the 101 patients analyzed, 54 had antifungal in the IGB and 47 only saline and methylene blue. In the group with antifungal the incidence of fungal colonization was 9.25% (n=5). In these 5 IGBs with fungal colonization, 4 (80%) presented light colonization (between 10% and 25% of the surface) and 1 (20%) with moderate colonization (between 25% and 50% of the surface). In the group without the use of antifungal the incidence of fungal colonization was 19.15% (n = 9). In these 9 IGBs with fungal colonization, 4 (44.5%) presented light colonization (between 10% and 25% of the surface), 3 (33.3%) with moderate colonization (between 25% and 50% of the surface) and 2 (22.2%) with accentuated colonization (more than 50% of the surface). There was no significant difference in outcomes between men and women and mean age was 30.49 years. The mean weight loss was -20.64kg (+/- 16.8kg).
The use of mixed Nystatin to the saline solution in the IGB filling reduced the fungal colonization in the silicone coating by half, demonstrating that this practice has a positive effect with low cost and significant difference in fungal prevention. However, even associated with IGB friability, fungal colonization does not prove to be of such importance since balloon spontaneous deflation or leakage corresponded to only 1.66% of the total initial sample and the 14 patients who presented fungi in the IGB (13.86 %) did not present any clinical symptoms.