RESULTS
Of the total 5,874 patients included in the study, 430 were did not complete the 6 months follow-up due to complications that led to the early removal of the balloon. Therefore, statistical analyses considering complications were made with data from all participants included in the study (n = 5,874), while the analyses considering efficacy were made with data obtained with 5,444 patients.
The baseline characteristics of study participants are shown in Table 1 and complications during treatment are presented in Table 2. There were no deaths during IGB treatment.
The changes in anthropometric parameters during the 6 month of follow-up according to the degree of overweight are shown in Table 3. There was a significant decrease in body weight, in BMI and in excess weight during IGB treatment in the total group and in all groups with different degrees of overweight (Table 3). The % TWL was similar across the groups presenting different degrees of overweight. However, the %EWL was different between groups, being higher in the participants with pre-obesity.
The majority of the participants in the total group (85%) presented a % TWL ≥ 10% achieving success of treatment according to this parameter. Additionally, 93% presented a % EWL >25% and 14% finished the IGB treatment with a BMI < 25 kg/m2 (Table 4). The frequency of success of treatment according to %TWL was similar between groups with different degrees of overweight, while the % EWL differed between groups.
Although men compared to women presented lower %EWL, the %TWL was similar in both genders (Table 5). Despite the follow-up of patients included nutritional and psychological consultations, 149 patients (10.03%) did not attend any nutritional consultation. Adherence to nutritional treatment did not correlate with a greater excess weight loss (r=0.1022).
In the Multivariate analysis of the weight averages of the TWL group, the Pre-obesity group showed 66.37% as a degree of similarity in relation to the Grade I, Grade II, and Grade III groups. The Grade I Obesity group, on the other hand, showed a similarity level equal to 88.22% in relation to the Grade II and Grade III groups and, among the Grade II and Grade III groups, it was 96.79% (Figure 1).
In relation to the EWL group, the Pre-obesity group showed 96.25% as the degree of similarity in relation to the Grade I group. Between the Pre-obesity and Grade I groups with the Grade II and Grade III groups it was 48.80% and between the Grade II and Grade III groups was 84.57% (Figure 2).
According to Figures 3 and 4, there was a statistically significant difference in the comparison between each degree of obesity in each group, TWL, BMI, and EWL, with p <0.001 for all analyzes, with Figure 3 analyzing the mean values in each group and Figure 4 analyzed the variation of the standard deviation in the groups (p <0.001).