Ambar Mehta1, Anirudh Dwarakanath, MS2, Rohith M Bhethanabotla3, Hien T Nguyen, MD2. 1Johns Hopkins University School of Medicine, 2Johns Hopkins Bayview Medical Center Department of Surgery, 3Johns Hopkins University Krieger School of Arts and Sciences
Objective: To evaluate the safety and feasibility of LapSpace, an innovative, FDA-cleared, laparoscopic device with an inflatable element that can retract abdominal contents for creating and maintaining optimal exposure of the operative field, a necessity for successful laparoscopic procedures.
Description: For any laparoscopic surgery to be efficient, surgeons require optimal and stable exposure of the surgical field. Currently, maneuvers such as the Trendelenburg as well as metallic instruments are used to clear abdominal organs and other abdominal contents from the operating field. These methods unfortunately are only partially effective and can cause unintentional trauma. For example, abdominal contents often slide back into the operating field, and excessive manipulation of abdominal organs can lead to preventable complications. The LapSpace laparoscopic retractor is placed through a 10-mm trocar and controls an inflatable balloon at its tip. Once the device is inside the abdomen, the surgeon inflates the balloon and can control its positioning and retraction angle. A bed clamp provides permanent retraction and hands-free utilization. The balloon itself is a biocompatible polymer, made of nylon fibers and thermoplastic polyurethane, which is atraumatic to tissue and can hold sufficient tension and pressure. The retractor minimizes mobilization of the small intestines and stabilizes the abdominal organs.
Results: Eleven surgeons have utilized this device for more than 50 surgeries, including at least three total hysterectomies, one cholecystectomy, ten sleeve gastrectomies, one ileal interposition, two Nissen fundoplications, one adrenalectomy, and thirteen herniorrhaphies. A 15-question survey collected the surgeons’ feedback on the device’s safety, utility, ergonomics, and satisfaction. The surgeons overwhelmingly stated that this device provides optimal exposure of the operating field, minimizes risks of inadvertent tissue injuries, and reduces the tilt or the time spent by the patient in the Trendelenburg position. Each surgeon was satisfied with the ergonomics of the handle and noted that they would use the device again. One surgeon experienced minor difficulties with deflating the balloon completely.
Conclusions: The LapSpace inflatable retractor, with its novel inflatable component and manually-controlled retractor, has initially demonstrated versatility in a wide variety of operations, in providing an optimal operating field, and in reducing inadvertent tissue injuries. Due to the utility of this device, there is potential for it to become commonly used in many different types of minimally invasive procedures. This pilot study warrants further investigation into how this device can improve on efficacy, time, and costs of laparoscopic operations.
