Ensayo clínico multicéntrico para la resección de pólipos rectales mediante un nuevo dispositivo de acceso transanal híbrido laparoendoscópico / Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device

Introducción: Los pólipos complejos requieren el uso de técnicas endoscópicas avanzadas o la cirugía mínimamente invasiva para su abordaje. En los pólipos rectales es de especial relevancia llegar a un consenso de cuál es el mejor abordaje de estos para evitar infratratamientos o sobretratamientos que incrementen una morbimortalidad innecesaria. Métodos: Se describe un ensayo clínico piloto con un producto sanitario de primer uso en humanos multicéntrico y prospectivo. Se plantea la hipótesis que UNI-VEC® facilita la cirugía laparoendoscópica transanal para la extirpación de tumores rectales precoces. El objetivo principal es evaluar que es seguro y cumple los requisitos funcionales establecidos. Los secundarios son evaluar resultados, complicaciones y nivel de satisfacción.Resultados: Se reclutaron 16 pacientes en 12 meses con un seguimiento mínimo de dos meses. El tamaño medio ha sido de 3,4 cm, siendo el pólipo mayor de 6 cm. Respecto a la localización, la media se encontraba a 6,6 cm del margen anal. Se realizó resección endoscópica mucosa (REM) (6,3%), disección submucosa endoscópica (DSE) (43,8%), resección espesor completo (REC) (6,3%) y transanal minimally invasive surgery (TAMIS) (43,8%). El tiempo medio fueron 73,25 min; 56,3% utiliza una cámara de 30̊ y 43,8% el endoscopio flexible como instrumento de visión. El 56,3% son lesiones benignas y 43,8% malignas. En 87,5% se consigue resección completa. En cuanto a las complicaciones, se presenta sangrado leve (Clavien I) en 25, 6,3 y 21,4% a las 24 h, 48 h y siete días, respectivamente. La continencia se valora según la Escala de Wexner. A los siete días, 60% presentan continencia perfecta, 26,7% IF leve y 13,3% IF moderada. A los 30 días, 66,7% continencia perfecta, 20% IF leve y 13,3% IF moderada. A los dos meses se revisan cuatro de los pacientes que a los 30 días presentaban un Wexner superior al preoperatorio y se demuestra continencia perfecta en 25% de los pacientes, 50% leve y 25% moderada. (AU)

Introduction: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. Methods: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. Results: Sixteen patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic mucosal resection (EMR) (6.3%), endoscopic submucosal dissection (ESD) (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days, respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. (AU)

Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device.

INTRODUCTION: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. METHODS: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. RESULTS: 16 patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic Mucosal Resection (EMR) (6.3%), Endoscopic Submucosal Dissection ESD (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. In no case did rectal perforation or major complications requiring urgent reintervention occur. As for the level of reproducibility, safety, level of satisfaction with the device and evaluation of the blister, the evaluation on a scale of 0-10 (9.43, 9.71, 9.29 and 9.50 respectively). All the investigators have previous experience with transanal devices. CONCLUSIONS: The study demonstrates the efficacy and safety of UNI-VEC® for the treatment of rectal lesions. It will facilitate the implementation of hybrid procedures that seek to solve the limitations of pure endoscopic techniques by allowing the concomitant use of conventional laparoscopic and robotic instrumentation with the flexible endoscope.