Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details

Introduction

Laparoscopic cholecystectomy is now the standard procedure for gallbladder removal due to lower morbidity and higher patient satisfaction than the open approach, and is currently the most performed operation worldwide. As laparoscopy evolves, techniques are modified to create smaller incisions and minimize abdominal wall trauma, such that 2 mm ports are routine in the surgeon’s armamentarium. The next logical step in the evolution of laparoscopic surgery is to decrease the number of ports, with the ultimate goal of operating through a single, minimal access port site. Multiple devices and techniques are now available for single-site access, generating interest in many surgical sub-specialties such as urology, gynecology, bariatric and gastrointestinal surgery. Flexible instruments are also available, but current technology does not achieve adequate triangulation for optimal surgical manipulation and visualization. Additional limitations of current devices include large access incisions (25–30 mm) with potential for increased risk of incisional hernia, prolonged operative time, and increased risk of common bile duct injury. As response to criticisms of current single-site surgical devices, Fortimedix Surgical B.V. developed a novel single-incision surgical platform (from here forward referred to as ‘‘the platform’’) compatible for insertion through a standard 15-mm trocar. The unique design of this technology allows introduction of two non-crossing, articulating instruments featuring improved triangulation, accuracy of tissue manipulation, and ergonomics. The objective of this study is to evaluate the safety and feasibility of the platform for use in single-site laparoscopic cholecystectomy. 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.

Method

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/m2, 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.

Result

Six patients (5 female) with an average age of 41 years and BMI 28 kg/m2 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.

Reference

RC Broderick, P Omelanczuk, CR Harnsberger, HF Fuchs, M Berducci, J Nefa, et al., “Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details,” Surg. Endosc., 2014.