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Introduction The development of EndoMaster EASE system aims to enhance safety and efficacy of colonic ESD through two flexible robotic arms for tissue retraction and dissection. This is the first clinical trial to evaluate the performance of colorectal ESD using EndoMaster. Method Patients with early mucosal colorectal neoplasia not feasible for en-bloc resection with snare-based techniques were recruited. The EndoMaster EASE robotic system consisted of an independently designed flexible robotic platform with 2 robotic arms. The primary outcome was complete resection rate using EndoMaster. Secondary outcomes included operating time, hospital stay, procedure-related complications and oncological outcomes. Results From May 2020 to Jan 2022, 43 patients received robotic ESD with median age of 66 years (40-83). The mean robotic dissection time was 62.0 ± 45.1 minutes. All procedures except six were completed using EndoMaster with technical success rate of 86.1% (37/43). The en-bloc resection rate among cases with technical success was 94.6% (35/37) while the complete resection rate was 83.8% (31/37). The median size of specimen was 35mm (15-90mm). The mean hospital stay was 2.6 ± 1.2 days and there was one delayed bleeding 4 days after ESD which was controlled by endoscopy. One patient sustained perforation during procedure which was completely closed using clips without sequelae. 2 patients required salvage surgery due to deep margin involvement by adenocarcinoma in histopathology. Conclusion This first clinical trial confirmed the safety and efficacy of performing colorectal ESD using EndoMaster EASE robotic system (Clinicaltrial.gov: NCT04196062).
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BACKGROUND: With increasing number of clinical trials relating to fecal microbiota transplantation (FMT), it is crucial to identify and recruit long-term, healthy, and regular fecal donors. OBJECTIVE: We aimed to report the outcomes of screening and recruitment of fecal donors for FMT. METHODS: Potential donors were recruited via advertisement through internal mass emails at a university. They were required to undergo a pre-screening telephone interview, a detailed questionnaire, followed by blood and stool investigations. RESULTS: From January 2017 to December 2020, 119 potential donors were assessed with 75 failed pre-screening. Reasons for failure included: inability to come back for regular and long-term donation (n = 19), high body mass index (n = 17), underlying chronic illness or on long-term medications (n = 11), being healthcare professionals (n = 10), use of antibiotics within 3 months (n = 5) and others (n = 13). Forty-four donors completed questionnaires and 11 did not fulfill the clinical criteria. Of the remaining 33 potential donors who had stool and blood tests, 21 failed stool investigations (19 extended-spectrum beta-lactamase [ESBL] organisms, one Clostridioides difficile, one C. difficile plus Methicillin Resistant Staphylococcus aureus), one failed blood tests (high serum alkaline phosphatase level), one required long-term medication and nine withdrew consent and/or lost to follow-up. In total, only one out of 119 (0.8%) potential donors was successfully recruited as a regular donor. CONCLUSION: There was a high failure rate in donor screening for FMT. Main reasons for screening failure included high prevalence of positive ESBL organisms in stool and failed commitment to regular stool donation.