Initial clinical experience with a novel flexible endoscopic robot for transanal surgery.

BACKGROUND: 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. The aim of this study is to evaluate our initial clinical experience with this novel tool. METHODS: We 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. RESULTS: Between 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. 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.

Single-incision laparoscopic cholecystectomy is responsible for increased adverse events: results of a meta-analysis of randomized controlled trials.

BACKGROUND: Over the last decade, single-incision laparoscopic cholecystectomy (SLC) has gained popularity, although it is not evident if benefits of this procedure overcome the potential increased risk. Aim of the study is to compare the outcome of SLC with conventional multi-incision laparoscopic cholecystectomy (MLC) in a meta-analysis of randomized controlled trials only. METHODS: A systematic Medline, Embase, and Cochrane Central Register of Controlled Trials literature search of articles on SLC and MLC for any indication was performed in June 2017. The main outcomes measured were overall adverse events, pain score (VAS), cosmetic results, quality of life, and incisional hernias. Linear regression was used to model the effect of each procedure on the different outcomes. RESULTS: Forty-six trials were included and data from 5141 participants were analysed; 2444 underwent SLC and 2697 MLC, respectively. Mortality reported was nil in both treatment groups. Overall adverse events were higher in the SLC group (RR 1.41; p < 0.001) compared to MLC group, as well severe adverse events (RR 2.06; p < 0.001) and even mild adverse events (RR 1.23; p = 0.041). This was confirmed also when only trials including 4-port techniques (RR 1.37, p = 0.004) or 3-port techniques were considered (RR 1.89, p = 0.020). The pain score showed a standardized mean difference (SMD) of - 0.36 (p < 0.001) in favour of SLC. Cosmetic outcome by time point scored a SMD of 1.49 (p < 0.001) in favour of SLC. Incisional hernias occurred more frequently (RR 2.97, p = 0.005) in the SLC group. CONCLUSIONS: Despite SLC offers a better cosmetic outcome and reduction of pain, the consistent higher rate of adverse events, both severe and mild, together with the higher rate of incisional hernias, should suggest to reconsider the application of single incision techniques when performing cholecystectomy with the existing technology.