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Evaluation of the Effectiveness of the Application of Argon Gas and / or Metal Clip for the treatment of patients who Regained Weight in the postoperative period of Stomach Reduction Surgery

Endoscopic Profile and Application of Argon Plasma and / or Metal Clip in patients undergoing Gastric Bypass after Weight Regain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10jyygyg
Enrollment
Unknown
Registered
2021-09-22
Start date
2018-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight loss

Interventions

All the 66 patients will be submitted to endoscopic exams, which will be performed at HB in São José do Rio Preto, with patients on fasting for at least 8 hours. With the patient in the left lateral p

Sponsors

Faculdade de Medicina de São Jose do Rio Preto
Lead Sponsor
Faculdade de Medicina de São Jose do Rio Preto
Collaborator

Eligibility

Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime frame
Secondary outcomes are not expected;Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactGustavo Gurian
gustavo_gurian@hotmail.com+55-11-953069741

Outcome results

None listed

Source: REBEC (via WHO ICTRP)