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

Autor: Noguera Aguilar JF; Servicio de Cirugía General & Aparato Digestivo del Complexo Hospitalario Universitario A Coruña (CHUAC), La Coruña, Spain., Gómez Dovigo A; Servicio de Cirugía General & Aparato Digestivo del Hospital QuirónSalud A Coruña, La Coruña, Spain. Electronic address: alba.gomez.dovigo@sergas.es., Aguirrezabalaga González J; Servicio de Cirugía General & Aparato Digestivo del Complexo Hospitalario Universitario A Coruña (CHUAC), La Coruña, Spain., González Conde B; Servicio de Digestivo del Complejo Hospitalario Universitario, A Coruña (CHUAC), La Coruña, Spain., Alonso Aguirre P; Servicio de Digestivo del Complejo Hospitalario Universitario, A Coruña (CHUAC), La Coruña, Spain., Martínez Ares D; Servicio de Digestivo del Hospital QuirónSalud A Coruña, La Coruña, Spain., Sánchez González J; Servicio de Cirugía General & Aparato Digestivo del Hospital Universitario Río Ortega, Valladolid, Spain., Díez Redondo MP; Servicio de Digestivo del Hospital Universitario Río Ortega, Valladolid, Spain., Maseda Díaz O; Servicio de Cirugía General & Aparato Digestivo del Hospital Universitario Lucus Augusti (HULA), Lugo, Spain., Torres García MI; Servicio de Cirugía General & Aparato Digestivo del Hospital Universitario Lucus Augusti (HULA), Lugo, Spain., Dacal Rivas A; Servicio de Digestivo del Hospital Universitario Lucus Augusti (HULA), Lugo, Spain., Delgado Rivilla S; Servicio de Cirugía General y Digestiva, Hospital Universitari Mútua Terrassa, Terrassa, Spain., Romero Marcos JM; Servicio de Cirugía General y Digestiva, Hospital Universitari Mútua Terrassa, Terrassa, Spain., Ramírez Ruíz P; Servicio de Digestivo, Hospital Universitari Mútua Terrassa, Terrassa, Spain., de María Pallarés P; Servicio de Digestivo, Hospital Universitario La Paz, Madrid, Spain., Álvarez Gallego M; Servicio de Cirugía General & Aparato Digestivo, Hospital Universitario La Paz, Madrid, Spain., Gómez Besteiro I; Unidad de apoyo a la investigación del CHUAC, La Coruña, Spain.
Jazyk: angličtina
Zdroj: Cirugia espanola [Cir Esp (Engl Ed)] 2023 Jun; Vol. 101 (6), pp. 435-444. Date of Electronic Publication: 2022 Dec 21.
DOI: 10.1016/j.cireng.2022.12.001
Abstrakt: 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.
(Copyright © 2022 AEC. Published by Elsevier España, S.L.U. All rights reserved.)
Databáze: MEDLINE
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