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.