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Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314

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Abstract

Background

Single-incision minimally invasive surgery has previously been associated with incisions 2.0–3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar we previously described in six patients with short-term follow-up data. The objective of this phase II study was to evaluate the safety and feasibility of the platform in a larger collective and to evaluate 1-year follow-up data of the phase I trial.

Methods

The technology features a multiple-use introducer, accommodating the articulating instruments, and is inserted through a 15-mm laparoscopic trocar. Cholecystectomy is performed through an umbilical incision. A prospective feasibility study was performed at a single center. Inclusion criteria were age of 18–75 years and biliary colic, exclusion criteria were acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m2, or choledocholithiasis. Endpoints included complications, length of stay, pain medication, cosmetic results, and the presence of hernia.

Results

Twenty-seven patients (23 females; phase I: 6 patients, phase II: 21 patients) with an average age of 41.7 years and BMI 26.6 kg/m2 were recruited for the study. Umbilical incision length did not exceed 15 mm. There were no intraoperative complications. Average OR time decreased from 91 min for the first six cases to 56 min for the last six cases. Average length of stay was 7.8 h. Pain control was achieved with diclofenac for no more than 7 days. All patients had no adverse events at 5-month follow-up, and all phase I patients had no adverse events nor evidence of umbilical hernia at 1 year.

Conclusion

This study demonstrates that single-incision cholecystectomy with the platform is feasible, safe, and reproducible in a larger patient population. Long-term follow-up showed no hernias or other adverse events. Further studies will be needed to evaluate longer-term hernia rates.

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Acknowledgments

This study was made possible by funding support received from Fortimedix Surgical B.V. (grant).

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Author notes

    Authors and Affiliations

    1. Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA

      Martin Berducci, Hans F. Fuchs, Ryan C. Broderick, Cristina R. Harnsberger, Joshua Langert, Garth R. Jacobsen, Bryan J. Sandler & Santiago Horgan

    2. Hospital Italiano de Mendoza, Mendoza, Argentina

      Martin Berducci, Pablo Omelanczuk, Jorge Nefa, Pablo Jaureguiberry, Pablo Gomez & Laura Miranda

    3. Department of Surgery, University of Cologne, Cologne, Germany

      Hans F. Fuchs

    4. VA Healthcare, San Diego, San Diego, CA, USA

      Bryan J. Sandler

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    1. Martin Berducci
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    2. Hans F. Fuchs
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    Corresponding author

    Correspondence to Hans F. Fuchs.

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    Disclosures

    This study was made possible by funding support received from Fortimedix Surgical B.V. Dr. Pablo Omelanczuk is an investigator for Fortimedix Surgical B.V. Dr. Santiago Horgan is an investigator, maintains stock options, and is on the advisory board for Fortimedix Surgical B.V. Drs. Berducci, Fuchs, Broderick, Harnsberger, Langert, Nefa, Jaureguiberry, Gomez, Miranda, Jacobsen, and Sandler have no conflicts of interest or financial ties to disclose.

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    Martin Berducci and Hans F. Fuchs have contributed equally to this manuscript.

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    Berducci, M., Fuchs, H.F., Omelanczuk, P. et al. Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314. Surg Endosc 30, 953–960 (2016). https://doi.org/10.1007/s00464-015-4319-2

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    • DOI: https://doi.org/10.1007/s00464-015-4319-2

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