Polese Lino, Rizzato Roberto, Porzionato Andrea, Da Dalt Gianfranco, Bressan Alice, De Caro Raffaele, Merigliano Stefano
Department of Surgery, Oncology and Gastroenterology, Section of Surgery, University of Padova, Clinica Chirurgica 3^, Sesto Piano Policlinico, Via Giustiniani 2, 35128, Padova, Italy.
Department of Neuroscience, Section of Human Anatomy, University of Padova, Padova, Italy.
Int J Colorectal Dis. 2020 Sep;35(9):1681-1687. doi: 10.1007/s00384-020-03641-8. Epub 2020 May 24.
The study aimed to evaluate the feasibility and safety of a new trans-anal rectoscopic-assisted minimally invasive surgery (ARAMIS) platform to treat rectal lesions.
ARAMIS was first compared with two transanal minimally invasive surgery platforms (SILS Port and GelPOINT Path) on human cadavers. Surgeons with different experience performed running sutures at different distances, at four quadrants, using the three platforms and gave a score to visibility, safety, and maneuverability. ARAMIS was then utilized on patients affected with rectal neoplasia who met the inclusion criteria. Patients and tumor characteristic and results were prospectively collected. The follow-up examinations included proctoscopy at 3, 6, and 12 months.
According to surgeons' scores, ARAMIS improves visibility and safety with respect to other platforms for distances beyond 10 cm. The procedure, which lasted an average of 59 min, was successfully carried out in 14 patients. No intraoperative or postoperative complications were reported. The mean tumor size was 3 cm; they were located a mean of 11 cm from the anal verge. Complete removal of the lesion was possible in 13/14 patients. There was one case of adenoma recurrence at follow-up.
Study results showed that ARAMIS, which is equipped with an adjustable rectoscope, can be considered a safe, effective platform for transanal surgery. The rectoscope protects the rectum during the procedure, a particularly important consideration when proximal rectal lesions are being treated. Further clinical studies are warranted to confirm these encouraging results.
本研究旨在评估一种新型经肛门直肠镜辅助微创手术（ARAMIS）平台治疗直肠病变的可行性和安全性。
首先在人体尸体上对ARAMIS与两种经肛门微创手术平台（SILS Port和GelPOINT Path）进行比较。不同经验的外科医生使用这三种平台在四个象限不同距离处进行连续缝合，并对视野、安全性和可操作性进行评分。然后将ARAMIS应用于符合纳入标准的直肠肿瘤患者。前瞻性收集患者和肿瘤特征及结果。随访检查包括在3个月、6个月和12个月时进行直肠镜检查。
根据外科医生的评分，对于距离超过10 cm的情况，ARAMIS在视野和安全性方面优于其他平台。该手术平均持续59分钟，14例患者手术成功完成。未报告术中或术后并发症。肿瘤平均大小为3 cm；平均距离肛缘11 cm。14例患者中有13例病变完全切除。随访中有1例腺瘤复发。
研究结果表明，配备可调节直肠镜的ARAMIS可被视为一种安全、有效的经肛门手术平台。直肠镜在手术过程中可保护直肠，在治疗直肠近端病变时这是一个特别重要的考虑因素。需要进一步的临床研究来证实这些令人鼓舞的结果。
