RESULTS
The complications were analyzed taking into account the total number of patients in the study period (n=180, 34.4% Males). Complications during treatment are shown in Table 1 . There were no deaths resulting from complications.
Of these patients (n=180), eight (4.44%) were intolerant to the balloon between two and four weeks and agreed to volume adjustment. Four did the downward adjustment in the second week after implantation and four in the fourth week. The range of volume that was removed was 220 mL (150-400 mL). 86 patients did the upward adjustment and from this, three (6.52%) presented intolerance after this procedure. All of the patients were submitted one week later to downward adjustment of 50% of the volume that was placed in upward adjustment (150-210 mL) and kept in treatment.
The baseline patient characteristics are reported in Table 2.
Changes in body weight, BMI and EWL are shown in Table 3 . The data is reported in the total group of patients and separately for those who did the upward adjustment (n=86) and those who didn’t (n=94). There was a significant decrease in all these nutritional parameters during the study period.
Eighty-six patients (47.78%) underwent upward adjustment. The adjustment resulted in a further mean weight loss of 4.2kg (-9 to 20kg), the standard upward volume was 250 mL and the moment of the procedure was 7.06±1.64 months (2-10). The upward adjustment group doesn´t have a higher %TWL, %EWL or a higher BMI reduction when compared to the group that did not (p=0.4413, p=0,9245, p=0.2729, respectively).
In terms of %EWL, fourty patients (22.22%) did not meet the treatment goal (EWL<25%). According to the %TWL, fifty two patients (28.89%) did not achieve treatment success (TBWL<10%). Twenty one patients (11.66%) finished the study under BMI of 25 kg/m² (Table 4 ). The success rate was superior in patients that did the upward adjustment (77.91%) compared to those who did not (64.89%).
Figures 1 and 3 show the Dendogram graphs with the degree of percentage similarity between the values of the average reduction of the total weight loss in kilograms (TWL) and the excess weight loss in kilograms (EWL), with and without adjustment of Spatz3®, with values of 77.07% and 76.44%, respectively. Figures 2 and 4 showed, using the Box-Plot graph, the intervals, mean and median of the TWL and the EWL reduction values, with and without Spatz3® adjustment, and the p-value values were, respectively, p = 0.056>0.05, and p=0.058>0.05, both with no statistically significant difference.