Background <p>Linear magnetic compression is a novel technique to perform gastrointestinal anastomosis.</p> Objective <p>This Italian multi-center clinical investigation aimed to evaluate the feasibility, safety and efficacy of the creation of a side-to-side compression anastomosis using the GT Metabolic Solutions™ Magnet System, DI Biofragmentable (MagDI™ System) to achieve duodeno-ileal diversion.</p> Methods <p>Patients with a body mass index (BMI) of ≥ 30 to 50&#xa0;kg/m<sup>2</sup> and weight regain and/or type 2 diabetes mellitus (T2DM) after sleeve gastrectomy (SG) and patients with a BMI of ≥ 30 to 35&#xa0;kg/m<sup>2</sup> and T2DM underwent a side-to-side duodeno-ileal diversion using the GT Metabolic™ DI Magnet (linear, 39&#xa0;mm).</p> Results <p>28 patients (19&#xa0;F) underwent surgery in 4 centers in the time between 09/24 and 02/25. Mean age and BMI were 44 years and 36.7 ± 4.4&#xa0;kg/m<sup>2</sup>. Mean operative time and hospital stay were 73.2&#xa0;min and 1.6 days. Paired magnets were expelled in all patients in a mean of 37.3 days. There were three procedure-related serious adverse events (Clavien Dindo III, one ileal perforation on POD 1, one liver insufficiency leading to reversal on POD 144 and one trocar site hernia on POD 203). Mean BMI, %EWL and %TWL at 90 days (<i>n</i> = 23) were 32.7 ± 0.8&#xa0;kg/m<sup>2</sup>, 36.6 ± 4.6% and 10.4 ± 1.1%. Mean HbA1c decreased from 6% at baseline to 5.7% at 30 days and to 5.5% at 90 days.</p> Conclusion <p>Preliminary data shows that side-to-side magnet compression duodeno-ileal anastomosis was feasible, safe and effective. Future follow-up data is necessary.</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions™ Magnet System, DI Biofragmentable (MagDI™ System) to Achieve Duodeno-Ileal Diversion in Patients with Obesity: Preliminary Italian Multi-Center Results

  • Sonja Chiappetta,
  • Paolo Gentileschi,
  • Stefano Olmi,
  • Giovanni Cesena,
  • Marco Anselmino,
  • Michel Gagner

摘要

Background

Linear magnetic compression is a novel technique to perform gastrointestinal anastomosis.

Objective

This Italian multi-center clinical investigation aimed to evaluate the feasibility, safety and efficacy of the creation of a side-to-side compression anastomosis using the GT Metabolic Solutions™ Magnet System, DI Biofragmentable (MagDI™ System) to achieve duodeno-ileal diversion.

Methods

Patients with a body mass index (BMI) of ≥ 30 to 50 kg/m2 and weight regain and/or type 2 diabetes mellitus (T2DM) after sleeve gastrectomy (SG) and patients with a BMI of ≥ 30 to 35 kg/m2 and T2DM underwent a side-to-side duodeno-ileal diversion using the GT Metabolic™ DI Magnet (linear, 39 mm).

Results

28 patients (19 F) underwent surgery in 4 centers in the time between 09/24 and 02/25. Mean age and BMI were 44 years and 36.7 ± 4.4 kg/m2. Mean operative time and hospital stay were 73.2 min and 1.6 days. Paired magnets were expelled in all patients in a mean of 37.3 days. There were three procedure-related serious adverse events (Clavien Dindo III, one ileal perforation on POD 1, one liver insufficiency leading to reversal on POD 144 and one trocar site hernia on POD 203). Mean BMI, %EWL and %TWL at 90 days (n = 23) were 32.7 ± 0.8 kg/m2, 36.6 ± 4.6% and 10.4 ± 1.1%. Mean HbA1c decreased from 6% at baseline to 5.7% at 30 days and to 5.5% at 90 days.

Conclusion

Preliminary data shows that side-to-side magnet compression duodeno-ileal anastomosis was feasible, safe and effective. Future follow-up data is necessary.