Abstract

BackgroundThe Flex® Robotic System (Medrobotics, Raynham, MA, USA) is the first miniaturised flexible endoscopic robot that aims to allow surgical manoeuvres beyond the area currently reached by transanal endoscopic microsurgery. The aim of this study is to evaluate our initial clinical experience with this novel tool.MethodsWe prospectively collected all consecutive cases of local excisions of rectal lesions performed with the Flex® Robotic System performed at the Department of Surgical Sciences of the University of Turin between October 2018 and December 2019. Indications were benign, or early rectal lesions judged unsuitable for endoscopic removal, within 20 cm of the anal verge. Debriefing meetings after each procedure allowed technology assessment leading to the modification, development, and implementation of tools according to the clinical experience. We analysed the data in terms of the safety and efficacy of treatment.ResultsBetween October 2018 and February 2020, 26 patients were treated. We performed a full-thickness excision in 14 patients and a submucosal dissection in 12. The median operating time was 115 min (range 45–360 min). In six patients (23.1%), we converted to standard transanal endoscopic operation (TEO®) (Karl Storz, Tuttlingen, Germany) to complete the procedure. The 30-day morbidity rate was 11.5% (3/26). Positive resection margins were detected in 4 (15.4%) patients. At a minimum follow-up of 12 months, 2 (7.7%) local recurrences were observed.ConclusionsThis first clinical series demonstrates that the Flex® Robotic System is a fascinating technology that deserves further development to increase surgical dexterity, thereby overcoming current technical limitations and improving clinical outcomes.

Highlights

  • According to the document "Against Cancer" on cancer screening in the European Union (2017) [1], colorectal cancer (CRC) is one of the three most frequent cancers in the world

  • When attempts are made to resect larger tumours via endoscopic mucosal resection (EMR) there is a risk of dividing the tumour into fragments and spreading cancer cells

  • We evaluate the technology and the technique in our series of transanal local excisions performed with the ­Flex® Robotic System

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Summary

Introduction

According to the document "Against Cancer" on cancer screening in the European Union (2017) [1], colorectal cancer (CRC) is one of the three most frequent cancers in the world. The introduction of less invasive screening tools will encourage further compliance with these programs. Endoscopic submucosal dissection (ESD) was developed 20 years ago in an attempt to resect lesions in one piece, reducing the risk of cancers spreading and permitting precise pathological staging. The ­Flex® Robotic System (Medrobotics, Raynham, MA, USA) is the first miniaturised flexible endoscopic robot that aims to allow surgical manoeuvres beyond the area currently reached by transanal endoscopic microsurgery. Debriefing meetings after each procedure allowed technology assessment leading to the modification, development, and implementation of tools according to the clinical experience. In six patients (23.1%), we converted to standard transanal endoscopic operation ­(TEO®) (Karl Storz, Tuttlingen, Germany) to complete the procedure. Conclusions This first clinical series demonstrates that the ­Flex® Robotic System is a fascinating technology that deserves further development to increase surgical dexterity, thereby overcoming current technical limitations and improving clinical outcomes

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