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A multicentric prospective study evaluating the safety and efficacy of Kii® Fios® First Entry Trocar in laparoscopic bariatric surgery

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Abstract

Introduction

Laparoscopic surgery has evolved as an important field of surgery due to its clear benefits when compared to open laparotomy surgery. However, specific complications of laparoscopic surgery have been reported, of which the majority are complications associated with first entry to the abdominal cavity. The emergence of bariatric surgery, combined with the special considerations of the abdominal wall and cavity of obese patients, leads to seeking new modalities of access to the abdominal cavity in this specific population.Kii Fios First Entry Bladeless Trocar (Applied) is a new device that may allow surgeons to facilitate the creation of pneumoperitoneum. This prospective multicenter nonrandomized trial aims to evaluate the safety and efficacy of Kii Fios First Entry Bladeless Trocar in laparoscopic bariatric surgery.

Methods

In the period between December 2013 and June 2014, 588 patients were included by 18 surgeons from several French hospitals to undergo laparoscopic surgery using Kii Fios First Entry Trocar as a first-entry trocar. The surgeons filled out a questionnaire assessing the safety and efficacy of the trocar for every patient.

Results

There were no mortality and no major complications. However, 11 cases (1.87%) of minor complications (liver and greater omentum injuries) were reported. The surgeons reported successful entry in less than 1 min for 70.58% of the cases.

Conclusions

Kii Fios First Entry Trocar (Applied) is a safe and efficient method to establish first entry in laparoscopic bariatric surgery when all the recommendations are followed and respected.

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Acknowledgements

The study was financially sponsored by Applied Medical, but the authors maintained control over the study design, data collection, data analysis, and manuscript preparation.

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Authors and Affiliations

  1. CHU de Montpellier, Montpellier, France

    Marcelo Loureiro, Mohamad Ramadan, El Mehdi Skalli, Pierre Blanc, Jean Michel Fabre & David Nocca

  2. University Montpellier 1, Montpellier, France

    Marcelo Loureiro, Jean Michel Fabre & David Nocca

  3. Universidade Positivo, Rua Angelo Bom 315 casa 1, Curitiba, 81210340, Brazil

    Marcelo Loureiro

Authors
  1. Marcelo Loureiro
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  2. Mohamad Ramadan
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  3. El Mehdi Skalli
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  4. Pierre Blanc
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  5. Jean Michel Fabre
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  6. David Nocca
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Corresponding author

Correspondence to Marcelo Loureiro.

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Disclosures

David Nocca received honorarium for speaking engagements from Ethicon Endo-Surgery, MSD, Gore, and created patents for MID. Marcelo Loureiro, Mohamad Ramadan, El Mehdi Skalli, Pierre Blanc, and Jean Michel Fabre have no conflicts of interest or financial ties to disclose.

Human and animal rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Loureiro, M., Ramadan, M., Skalli, E. et al. A multicentric prospective study evaluating the safety and efficacy of Kii® Fios® First Entry Trocar in laparoscopic bariatric surgery. Surg Endosc 31, 4680–4687 (2017). https://doi.org/10.1007/s00464-017-5536-7

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  • DOI: https://doi.org/10.1007/s00464-017-5536-7

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