EXVIVO AND IN VIVO PORCINE ANIMAL MODEL FOR VALIDATION OF UNIVEC TRANSANAL DEVICE

Abstract

Abstract Introduction Colorectal cancer screening has led to a greater number of early lesions being diagnosed. At the rectal level, minimally invasive surgery has become more important since major surgery increases morbimortality. This experimental study evaluates the feasibility, safety, and effectiveness of the UNIVEC® device for both abdominal and transanal procedures and compares it to other devices prior to its commercialization and use in the clinical setting. Methods UNIVEC® is a transanal device with a pneumatically sealed channel that allows the introduction of the flexible endoscope and 2 accessory channels. Thirty-two porcine models were used in the 2-phase study. Results Phase I: 18 models and 2 procedures (hysterectomy and cystectomy) were used and UNIVEC® was compared with 2 devices (SILS®, GelPOINT®). Phase II: 14 models and 3 procedures (polypectomy, EMR, DSE). The final prototype design was satisfactory and met the established minimum performance requirements. Conclusions UNIVEC® is a transanal device that allows for hybridization of laparoscopic and endoscopic instrumentation. A model anatomically similar to that of the human was needed to assess intraoperative complications arising during surgery before its clinical application. The porcine model, due to its anatomical characteristics and experience, was the model of choice in our project. The ex vivo model facilitates learning the technique of the device prior to its use in vivo, which offers greater final cost-effectiveness.