Purpose: The purpose of this paper is to introduce a novel trans-illuminating culdotomy and uterine manipulator device.
Materials and methods: The study was a prospective, non-randomized, non-blinded observational clinical study involving 50 female patients undergoing total laparoscopic hysterectomy (TLH) or laparoscopic supracervical hysterectomy (LSH) for benign indications. The surgeries were performed from March through May 2012 at two institutions. The primary study objectives were to demonstrate the safety and adequate clinical performance of the uterine manipulator device and to illustrate its potential widespread future use in minimally invasive gynecologic procedures.
Results: Average patient age was 45.1 years and, of the 50 patients, 33 had undergone previous intra-abdominal surgery. There were no reports of adverse events, difficulty with placement of the instrument, multiple attempts at placement, or difficulty with uterine manipulation. There was only one device-related uterine perforation, and pneumoperitoneum was maintained in all cases during culdotomy. Vaginal tissue left on subjects was less than 5mm. Overall, there were no ureteral injuries, there were two reported incidental cystotomies, and average blood loss was 99.0cc. Postoperative courses were normal for all patients, with only two reported postoperative complications: a possible vaginal cuff abscess and a 2cm vaginal mucosal cuff separation.
Conclusions: The McCarus-Volker ForniSee® (LSI Solutions, Inc., Victor, New York) is a novel trans-illuminating culdotomy device and uterine manipulator that is safe, efficient, functional, and easy to use. Trans-illumination additionally delineates and enhances identification of critical anatomic planes, such as the vesicovaginal junction and cervicovaginal junction.