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Efficacy and Safety of Electrothermal Bipolar Vessel Sealer vs ENSEAL in Total Laparoscopic Hysterectomy for Large Uterus






















                                                               Fig. 3: ALAN generator
            Fig. 1: ENSEAL generator

                                                               MAterIAls And Methods
                                                               This is a prospective randomized case–control study done at JSS
                                                               Hospital, Mysuru, Karnataka including 100 women. Patients with
                                                               fibroid uteri of size between 12 weeks and 28 weeks were included
                                                               in the study. Patients with other indications for TLH were excluded.
                                                                  Patients included in the study were subjected to detailed
                                                               medical history check-ups and examination including abdominal,
                                                               vaginal, and bimanual examination. Institutional Ethics Committee
                                                               approval was obtained and after obtaining the informed consent
                                                               from the participating patients, the data collected were included
                                                               for statistical analysis.
                                                                  All procedures were performed by a single surgeon. Out of 100
                                                               women, 50 women who underwent TLH using ALAN vessel sealer
                                                               were considered in group A and the remaining 50 who underwent
                                                               TLH using ENSEAL were considered in group B. Protocols for
                                                               anesthesia, preoperative, and postoperative management were
                                                               the same among all the patients. Patients were followed up once
            Fig. 2: ALAN vessel sealer hand instrument         2-, 4-, and 6-week after the surgery to look for any subsequent
                                                               complications.
                                                                  The ENSEAL device is designed for laparoscopic vessel sealing
            defined bipolar sealing followed by dissection, thus giving better   and tissue transection. The first electrode is integrated into the
            hemostasis even in a large uterus. They also have cost-saving   static lower jaw of the device and the second one in the movable
            properties as a result of decreased operative time, decreased use   upper jaw. The impedance of the nano-based material of the upper
            of postoperative analgesics, and shorter duration of stay. These   electrode depends on the temperature and is based on the tissue
            devices have one major drawback that their instruments are   temperature; it regulates the energy output, thus not allowing the
            disposable and are of economic concern. 3,4        temperature to exceed 100°C. While moving the blade to the front
               The ENSEAL device (NSEAL 535RE, Ethicon Endo-Surgery   position, the double T-shaped cutting blade located longitudinally
            (Europe) GmbH) is used for laparoscopic tissue dissection and vessel   in the instrument axis closes the jaws. The coagulation and
            sealing. It uses nanometer-sized particles embedded in a bipolar   cutting processes occur almost simultaneously, and the clamping
            temperature coefficient matrix. The current flow is active only   force depends on the blade position in which the two jaws are
            when the device jaws are closed. The nanoparticles embedded in   substantially parallel in a closed position.
            them locally interrupt current flow to tissue when the temperature   The ALAN vessel sealer uses a special type of bipolar current for
            exceeds 100 °C, enabling sealing and transection to occur in a single   tissue dissection. Lower tissue impedance is sensed by the machine
            step and also minimizing the thermal spread and tissue damage.  following which it delivers a specially designed bipolar current for
               A new bipolar vessel sealing device (ALAN vessel sealer, Alan   the dissection instrument, plasma bisector. The jaws of the plasma
            Electronic Systems Pvt. Ltd., Thane, Maharashtra, India), which is   bisector are designed circularly, when the jaws are closed a very
            cost-effective as it is a reusable instrument, has been developed.   narrow portion of the plasma bisector comes in contact with the
            This study aimed to compare the efficacy, safety, and perioperative   tissues. This enables the maximum concentration of current and
            outcomes of ALAN vessel sealer vs ENSEAL in laparoscopic   rapid dissection of the tissues. The microplasma which is generated
            hysterectomy for a large uterus of more than 12-week size     following the passage of dissection current rapidly vaporizes the
            (Figs 1 to 3).                                     tissue held between the jaws of the plasma bisector. Due to the

             6    World Journal of Laparoscopic Surgery, Volume 14 Issue 1 (January–April 2021)
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