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Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details

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Abstract

Objective

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. The objective of this study is to evaluate the safety and feasibility of the platform.

Methods

The technology is currently a Phase I investigational device. It features articulating surgical instruments and is inserted through a multiple-use introducer. The platform’s introducer requires a standard 15-mm laparoscopic trocar. Cholecystectomy is performed through a 15-mm umbilical incision utilizing an additional epigastric 2-mm needle-port grasper for gallbladder retraction. A prospective feasibility study was performed at a single-center. Inclusion criteria were age 18–75 years and biliary colic. Patients were excluded if they had acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m2, or choledocholithiasis. Endpoints included the success rate of the platform, hospital length of stay, post-operative pain medication usage, cosmetic results, and presence of hernia.

Results

Six patients (5 female) with an average age of 41 years and BMI 28 kg/m2 underwent cholecystectomy with the platform. Average OR time was 91 min and umbilical incision length did not exceed 15 mm. One case was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. There were no intraoperative complications. Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h. Pain control was achieved with diclofenac for less than 7 days. At 1 month follow-up there were no complications and no umbilical hernias.

Conclusions

This phase I study demonstrates that single-incision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits include excellent triangulation and range of motion as well as exceptional cosmetic results. Further studies will be needed to evaluate long-term hernia rates.

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Disclosures

This study was made possible by funding support received from Fortimedix Surgical B.V. Drs. Ryan C Broderick, Pablo E Omelanczuk, Cristina R Harnbserger, Hans F Fuchs, Martin Berducci, Jorge Nefa, Javier Nicolia, Moneer Almadani, Garth R Jacobsen, and Bryan J Sandler have no conflicts of interest or financial ties to disclose. Dr. Santiago Horgan is an investigator, maintains stock options, and is on the advisory board for Fortimedix Surgical B.V.

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Authors and Affiliations

  1. Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California San Diego, San Diego, CA, USA

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

  2. Department of Bariatric Surgery and Upper GI Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina

    Pablo Omelanczuk

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

    Hans F. Fuchs

  4. Division of Hepatobiliary Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina

    Jorge Nefa

  5. Department of Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina

    Javier Nicolia

Authors
  1. Ryan C. Broderick
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  2. Pablo Omelanczuk
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  3. Cristina R. Harnsberger
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  4. Hans F. Fuchs
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  5. Martin Berducci
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  6. Jorge Nefa
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  7. Javier Nicolia
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  8. Moneer Almadani
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  9. Garth R. Jacobsen
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  10. Bryan J. Sandler
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  11. Santiago Horgan
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Corresponding author

Correspondence to Ryan C. Broderick.

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Broderick, R.C., Omelanczuk, P., Harnsberger, C.R. et al. Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details. Surg Endosc 29, 1250–1256 (2015). https://doi.org/10.1007/s00464-014-3779-0

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  • DOI: https://doi.org/10.1007/s00464-014-3779-0

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