Objective: Single-incision minimally invasive surgery has previously been associated with incisions 2.0-3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar. The objective of this study is to evaluate the safety and feasibility of the platform.
Methods: The technology is currently a Phase I investigational device. It features articulating surgical instruments and is inserted through a multiple-use introducer. The platform's introducer requires a standard 15-mm laparoscopic trocar. Cholecystectomy is performed through a 15-mm umbilical incision utilizing an additional epigastric 2-mm needle-port grasper for gallbladder retraction. A prospective feasibility study was performed at a single-center. Inclusion criteria were age 18-75 years and biliary colic. Patients were excluded if they had acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m(2), or choledocholithiasis. Endpoints included the success rate of the platform, hospital length of stay, post-operative pain medication usage, cosmetic results, and presence of hernia.
Results: Six patients (5 female) with an average age of 41 years and BMI 28 kg/m(2) underwent cholecystectomy with the platform. Average OR time was 91 min and umbilical incision length did not exceed 15 mm. One case was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. There were no intraoperative complications. Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h. Pain control was achieved with diclofenac for less than 7 days. At 1 month follow-up there were no complications and no umbilical hernias.
Conclusions: This phase I study demonstrates that single-incision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits include excellent triangulation and range of motion as well as exceptional cosmetic results. Further studies will be needed to evaluate long-term hernia rates.