Background <p>Robotic surgery has been increasingly used in colorectal surgery, where the improved visualization and dexterity are of benefit. The aim of this study was to confirm the perioperative and early postoperative safety and evaluate the clinical performance of the DEXTER<sup>®</sup> Robotic Surgery System in right colectomy.</p> Methods <p>A prospective, multicenter, post-market study was conducted across three sites in France, Germany, and Switzerland. Four surgeons performed the surgeries with DEXTER. The primary endpoints were major complications defined as Clavien–Dindo grades&#xa0;III–V, and procedural success rate. Secondary endpoints included perioperative safety and performance assessment up to 30&#xa0;days post procedure.</p> Results <p> A total of 33 patients with a median age of 71&#xa0;years (IQR 63–78) and BMI 25.4&#xa0;kg/m<sup>2</sup> (IQR 23.4–27.9) were enrolled. Robotic intracorporeal anastomosis was performed in 49% of the procedures. All procedures were completed without device-related conversion to open surgery. Two patients experienced Clavien–Dindo III–V complications, none of which were device-related. Median estimated blood loss was 100&#xa0;mL (IQR 20–120) with no blood transfusions. Operative time was 168&#xa0;min (IQR 152–197) and length of stay was 5&#xa0;days (IQR 4–6).</p> Conclusions <p>Right colectomy with DEXTER is feasible and the results of this study support the short-term safety and clinical performance of the device, even early in the learning curve. Studies with long-term follow-up and functional outcomes are needed to assess long-term safety and performance.</p> Clinical trial registration <p>ClinicalTrials.gov NCT05537727 (registered on 8 September 2022).</p>

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Robotic-assisted right colectomy with the DEXTER® Robotic Surgery System: first prospective multicenter study

  • J. Pochhammer,
  • T. Becker,
  • F. Grass,
  • H. Mignot,
  • D. Hahnloser

摘要

Background

Robotic surgery has been increasingly used in colorectal surgery, where the improved visualization and dexterity are of benefit. The aim of this study was to confirm the perioperative and early postoperative safety and evaluate the clinical performance of the DEXTER® Robotic Surgery System in right colectomy.

Methods

A prospective, multicenter, post-market study was conducted across three sites in France, Germany, and Switzerland. Four surgeons performed the surgeries with DEXTER. The primary endpoints were major complications defined as Clavien–Dindo grades III–V, and procedural success rate. Secondary endpoints included perioperative safety and performance assessment up to 30 days post procedure.

Results

A total of 33 patients with a median age of 71 years (IQR 63–78) and BMI 25.4 kg/m2 (IQR 23.4–27.9) were enrolled. Robotic intracorporeal anastomosis was performed in 49% of the procedures. All procedures were completed without device-related conversion to open surgery. Two patients experienced Clavien–Dindo III–V complications, none of which were device-related. Median estimated blood loss was 100 mL (IQR 20–120) with no blood transfusions. Operative time was 168 min (IQR 152–197) and length of stay was 5 days (IQR 4–6).

Conclusions

Right colectomy with DEXTER is feasible and the results of this study support the short-term safety and clinical performance of the device, even early in the learning curve. Studies with long-term follow-up and functional outcomes are needed to assess long-term safety and performance.

Clinical trial registration

ClinicalTrials.gov NCT05537727 (registered on 8 September 2022).