RESULTS
A total of 41 patients were randomized into 2 groups, the APC and Sham group, with each group having 21 and 20 patients respectively. The flowchart of selection and eligibility, as well as the randomization process of the patients selected in their respective APC and Sham groups, after applying the inclusion and exclusion criteria, is shown in Figure 1. In the APC group (4 men), age mean was 46.65 years, mean initial weight of 100.4 (range of 72-162) kg, mean initial BMI of 36.12 kg/m2 and mean weight recovered of 24.94 (range of 15 to 82). In the Sham group (7 men), the mean age was 49.53 years, the mean initial weight was 103.65 (range: 88.70-123.70) kg, the mean baseline BMI was 36.67 kg/m2 and the average recovered weight 25.18 (range: 19.50-32.30) Kg.
Only one complication occurred, stenosis after the first APC session, requiring no treatment since the patient tolerated a liquid diet, and remained in the study. The technique was 100% successful.
The overall results of both groups regarding relapsed weight loss, weight loss in kg, total body weight loss (% TBWL), excessive weight loss (% EWL), reduced BMI, reduced serum triglyceride level and glycosylated hemoglobin are shown in Table 1. Figure 2 shows the weight reduction of the two groups over time. The APC group had an average initial weight of 100.04 ± 22.27 and, after 6 months, the average weight was 85.02 ± 16.05 kg, with 15.02 ± 9.63 kg of weight reduction, thus, there was a statistically significant difference with p <0.0001 and R2 = 45.34% (CI 95%). The sham group did not present statistical difference regarding weight loss, with p> 0.0001 and R2 = 99.85% (CI 95%), with an average of initial and initial weight respectively equal to 103.65 ± 10.53 kg and 104.22 ± 10.06 kg, with a weight gain of 0.57 ± 2.23 kg. There was also a significant difference between the APC and Sham groups in relation to the final weight results, with p <0.0001. BMI values ​​in each group followed the same statistical results as weight values, as shown in Table 1 and Figure 3.
According to Figure 4, the values ​​of %RWL, percent Total body weight loss (%TWL), and percent EWL (%EWL) in relation to the APC group were 63.95 ± 32.08%, 14.46 ± 6.16%, and 54.32 ± 28.90%, respectively. Regarding the Sham group, they were respectively -2.65 ± 10.24, -0.62 ± 2.43, and -2.34 ± 9.03. The statistical comparison between groups was significant, with p <0.0001.
The GJA diameter values ​​in relation to the APC group were 34.25 ± 6.13 mm (initial), 12.65 ± 2.11 mm (final), with a reduction of 21.60 ± 3.19 mm, with p <0.0001 and R2 = 35.43% (CI 95%) . The sham group did not present statistical difference, with p> 0.0001 and R2 = 99.99% (CI 95%), with the same value of the initial and final anastomotic diameter equal to 35.16 ± 4.52 mm (Figure 5).
Several biochemical parameters were also analyzed. The mean values for total cholesterol, HDL and LDL before and after the SHAM group were 186.21 ± 25.36 mg/dL and 185.84 ± 24.27 mg/dL, 48.89 ± 11.26 mg/dL and 49.11 ± 10.16 mg/dL, 122.74 ± 25.36 mg/dL and 121.32 ± 27.36 mg/dL, respectively, with p> 0.0001. In the APC group, these values were 187.25 ± 23.36 mg/dL and 186.50 ± 22.23 mg/dL, 48.40 ± 8.26 mg/dL and 48.85 ± 8.18 mg/dL, 122.5 ± 24.34 mg/dL and 121.0 ± 25.14 mg/dL, respectively, with p> 0.0001. The detainees in the reduction of the average values were in relation to the APC group in relation to HbA1c, with an initial average of 5.66 ± 0.61% versus the final average of 4.96 ± 0.39% (p<0.0001), and triglycerides with an initial mean of 153.20 ± 25.13 mg/dL versus the final average of 132.20 ± 31.46 mg/dL (p <0.0001) (Figure 6).
There was a significant difference between the groups regarding the anastomotic diameter, with p<0.0001. Figure 7 represents the GJA diameter images at 2, 4, and 6 months after the application of the APC.