Weight loss
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The study will include patients undergoing Roux-en-Y gastric bypass and who, after 24 months of the procedure, presented weight relapse> 10% of the weight lost. In addition, participants must be over 18, of both sexes and of any ethnicity.
Exclusion criteria
Exclusion criteria: Exclusion criteria will be considered for patients under 18; those who do not accept or are not able to perform the endoscopy exam (s) and follow-up during the study; who abandon the study during its realization; with a history of liver disease with cirrhosis or chronic active hepatitis; anticoagulated or with known clotting disorders; pregnant women who became pregnant during the study period, or intend to become pregnant during the study; patients who are participating in other similar studies; severe malnourished, anemic, chronic alcohol users or drug users; patients allergic to sedatives used during the endoscopic procedure; with a history of recent neoplasia (after reduction surgery); HIV-positive; reoperated with bariatric surgeries or for similar purposes performed before or after the study surgery; with immediate or late postoperative complications that required further surgery; patients who underwent a surgical technique other than gastric bypass with Roux-en-Y reconstruction without placing the Silastic ring.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The analysis after 30 days (short term) showed a significant reduction in weight, excess weight and weight relapse between the group submitted to argon plasma ablation and the Control Group (p <000.1, for all variables). In this case, of the 38 patients submitted to APA (EG), 37 (97.3%) presented weight loss and one patient maintained weight during this period. The maximum weight loss was 11 kg, and the minimum loss was 1 kg, reaching a PP of 4.8 ± 2.7 kg,% PEP of 22.8 ± 33.7%,% PTP of 4.8 ± 2, 4% and RPR of 46.5 ± 34.4%. However, in the Control Group, of the 28 patients evaluated in the same period of 30 days (short term), 67.8% (N = 19) presented weight loss, 10.7% (N = 3) maintained their initial weight and 21, 4% (N = 6) gained weight. The maximum loss was 6 kg, the minimum 1 kg and the maximum gain of 2 kg in the period, with an average value for PP of 1.6 ± 2.0 kg,% PEP of 9.3 ± 13.9%, % PTP of 1.8 ± 2.2% and RPR of 17.1 ± 21.0% after 30 days (short term). The other periods, such as 60, 90 and 120 days, maintained the significant result of PP,% PEP,% PTP and RPR between CG and GE (p <000.1, for all variables). ;One year after the beginning of the follow-up (long term), the final analysis of the weight did not show any difference between the groups studied (p = 0.964). However, values for% PEP and% PTP were higher in the Study Group than in the Control Group (p = 0.038; p = 0.045, respectively). Of the 38 patients in the Study Group, 86.8% (N = 33) attended a one-year return visit, of these, 72.7% (N = 24) gained weight after the process, 21.2% (N = 7) lost weight and 6.0% (N = 2) maintained weight. They started the study with an average weight of 98.5 ± 21.2 kg, reaching 86.0 ± 13.2 kg after 90 days of PAC, returning to an average weight of 94.2 ± 21.6 kg after one year of discharge (long term), corresponding to an average value for PP of 1.5 ± 5.5 kg,% PEP of 15.1 ± 61.3%,% PTP of 1.8 ± 5.7% and RPR of 21.9 ± 62.9%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected;Secondary outcomes are not expected | — |
Countries
Brazil