Abstract
.The fluorescent imaging agent IS-001 was determined to be well tolerated in all subjects and has the potential to provide ureter visualization throughout minimally invasive hysterectomy procedures. This study was conducted to evaluate clinical safety and efficacy of a real-time ureter visualization technique for use during hysterectomy surgery. The study drug appears safe, is renally excreted, and allows enhanced ureter visualization when imaged with a clinically approved near-infrared sensitive endoscope. This is a first-in-human study showing preliminary results that the drug is safe and effective during surgery for improved ureter visualization.
Highlights
Ureteral injury is a serious complication of gynecological and colorectal surgery that frequently goes unrecognized intraoperatively.[1]
Avoidance of ureteral injury depends upon clear understanding of anatomic relationships and meticulous surgical technique, including careful dissection of pelvic structures.[6]
Iatrogenic ureteral injury remains a severe complication of pelvic surgery that imposes a significant burden in morbidity and health care cost
Summary
Ureteral injury is a serious complication of gynecological and colorectal surgery that frequently goes unrecognized intraoperatively.[1]. Risk factors for ureteral injury include the ureter’s close proximity to the gynecologic organs within the pelvis, distortion of normal anatomic relationships by pathology such as endometriosis, and surgeon experience.[5] Avoidance of ureteral injury depends upon clear understanding of anatomic relationships and meticulous surgical technique, including careful dissection of pelvic structures.[6]. Invasive surgery (MIS) offers several advantages over traditional open surgical techniques including reduced infection rates, shorter hospital stays, and rapid return to normal activities[7] and is becoming an increasingly more common approach for hysterectomy.[8] One potential drawback to all MIS approaches is an increased risk of inadvertent ureteral injury[7,9] when compared to open techniques. Intraoperative near-infrared (NIR) fluorescence imaging is a promising technique that offers real-time visual information
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