To evaluate a new magnetic surgical system during reduced-port laparoscopic cholecystectomy in a prospective, multicenter clinical trial.
This device is a magnetic surgical system. It is approved to grasp and retract the gallbladder during laparoscopic cholecystectomy procedures to facilitate visualization of the surgical site. It consists of a laparoscopic delivery system with a detachable end effector/grasper and an external magnet. The grasping component is inserted through a 10-mm trocar for delivery into the abdominal cavity, where the distal tip is used to grasp the gallbladder. Once grasping the gallbladder, the distal tip of the instrument is then detached from the shaft. It must then be manipulated into proximity of the external magnetic controller component placed on the abdominal wall. By moving the magnet on the external abdominal wall, the surgeon is able to change the degree of gallbladder retraction. The magnetic controller can be attached to standard retraction arm bracket systems. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2.
- Patients within a body mass index of 20-34 kg/m2 undergoing laparoscopic cholecystectomy
- Body mass index less than 20 or greater than 34 kg/m2Methods:
A prospective, single-arm, open-label study was performed to assess the safety and performance of a magnetic surgical system The investigational device was used during a 3-port laparoscopic technique. The primary endpoints evaluated were safety and feasibility of the device to adequately mobilize the gallbladder to achieve effective exposure of the targeted surgical site. Patients were followed for 30 days postprocedure.
Even after the wide adoption of laparoscopic surgery and its benefits, access techniques continued to evolve in the search for technologies that allow us to perform even less invasive procedures, and thus minimizing surgical damage to the patient. Efforts have taken place to reduce the size and number of all surgical instruments required for a given operation to reduce the number and size of incisions.Although reducing the number of ports might seem very appealing, this can represent demanding technical challenges, as this increases the difficulty of performing any surgery. The capability of triangulation is usually compromised; especially on reduced-port techniques and internal and external instrument clashing impairs the technical capability of any surgeon. In general, limited instrumentation may lead to inadequate visualization and poor organ mobilization, which may increase the risk for iatrogenic injury, the difficulty of the procedure, and prolong operating times, among other problems that result in poor outcomes.
There have been significant efforts to solve such challenges, such as needle-sized instruments, percutaneous sutures, and even internal retractors. Most of these solutions are, however, cumbersome, fragile and are static solutions in a dynamic environment that requires simple and reliable mobility. Moreover, such instrumentation may lead to organ perforation, with another subset of potential and severe complications. This combination of factors results in important constraints and limitations for reduced-port surgery.
The magnetic grasper assembly delivers and applies the detachable grasper tip to the gallbladder. Gently squeezing the handle, the internal mechanism releases the detachable tip. The handle is then removed, leaving the introduction port available for use by another procedural instrument. With the detachable grasper tip secured to the organ, the external magnet is placed over the abdominal wall and a magnetic attraction is achieved with the detachable tip. The external magnet can then be freely moved, facilitating unconstrained shaftless tissue retraction and mobilization. Under direct visualization, the desired retraction of the gallbladder can be obtained by mobilizing the external magnet. The usual position of the external magnet is on top of the right upper quadrant. At the end of the procedure, the detachable grasper tip is decoupled from the external magnet, reconnected to the handle and removed from the patient.
- Magnetic surgery technologies might overcome some of the challenges inherent in reducing the number of ports while avoiding the problems that current attempts might impose on the surgeons. The Magnetic Surgical System assessed in this work was able to reduce the number of ports needed to adequately perform retraction, conserve triangulation, and generate an adequate surgical area in a safe and efficient way. The system was evaluated as easy to use and the time to grasp the organ and connect with the external magnet was, on average, less than 30 and 60 seconds, respectively. These features might affect in its clinical adoption, as easy-to-use devices with a clear clinical benefit have a higher adoption rate. These times are reasonable in comparison with described times for conventional 4-port gallbladder removal.
This technology represents a “shaft-less” device; therefore, any potential clashing of instrument shafts would be less likely. This could also improve visualization in procedures in which the long shaft of instruments might interfere with the visual field of the surgeon. Another potential benefit, besides the reduction of invasiveness for the reduction of ports, is the potential increase in mobility that this new technology can bring.