A new bipolar device for sealing and cutting: ex and in vivo studies for performance evaluation

Figures & data

Figure 1. Overview of the in vivo study design including open or laparoscopic surgical subtasks per operator. Four experienced operators, two gynecologists, one visceral surgeon and one thoracic surgeon performed 13 surgical subtasks. EDS = Erbe Dissector, EG2 = ENSEAL G2.

Table 1. Intraoperative and postoperative questionnaire (Likert items).

Topic	Statement
Tissue sticking^a	Adhesion of tissue to the instrument is not disturbing.
Sharp dissection (thermal spread)^a	Unintended thermal lateral damage during dissection does not occur.
Sharp dissection (speed of dissection)^a	Working speed during dissection is optimal.
Blunt dissection (repositioning tissue)^a	The instrument is optimal for repositioning the tissue.
Blunt dissection (spreading tissue)^a	The instrument is optimal for spreading tissue to separate tissue layers.
Blunt dissection (visibility of tissue)^a	I am able to see the contact point between instrument and tissue during blunt preparation.
Blunt dissection (feasibility of otomy creation)^a	The instrument is optimal for creating an otomy.
Quality as a surgical gripping forceps^a	The instrument is ideally suited for use as a gripper.
Hemostasis with coagulation mode^a	Hemostasis during coagulation with the blue button is optimal.
Information on tissue strength/tightness^a	I am able to feel the tissue consistency via the instrument.
Precision (working in small steps)^a	I am able to work precisely by proceeding in small steps.
Precision (close to sensitive structures)^a	I am able to work precisely in the immediate vicinity of a sensitive structure.
Feasibility for work in tight spaces^a	Working in tight spaces is optimally supported by the instrument.
Overall rating^b	How do you rate the instrument overall?
Working speed^b	How do you rate the working speed?
Precise dissection^b	How do you rate its use for fine or precise surgical steps (e.g., lymphadenectomy)?
Hemostasis^b	How do you rate use of the device for surgical steps where blood-dry sealing of thicker tissue layers is important (e.g., cutting of ligaments in hysterectomy)?
Thermal lateral damage^b	How do you evaluate the lateral thermal dispersion zone?
Ergonomics^b	How do you rate the ergonomics of the instrument?
Usability (manual forces)^b	How would you rate the manual force required to operate the instrument?
Usability (accessibility of all control elements)^b	How do you rate the accessibility of all control elements?
Surgical smoke (visibility)^b	The smoke generated by the system does not impair the view in the operating field.
Surgical smoke (smell)^b	The smoke produced by the system does not interfere with smell.
Tissue carbonization^b	There is no charring of tissue during dissection.
Overall rating^b	How do you rate the instrument overall?
Working speed^b	How do you rate the working speed?

^aintraoperative questions.

^bpostoperative questions.

Figure 2. For the Erbe Dissector (EDS) with a dedicated EDS generator mode (a) Vessel sealing success rate ex vivo for renal arteries and microscope image of sealed vessel with the seal zone and lateral thermal spread (b) Vessel sealing success rate in vivo for vessels with diameters 2-6 mm (filled), arteries (dotted), veins (hatched) and all vessels (no filling).

Figure 3. (a) Seal and cut time (median with IQR) with the Erbe Dissector (EDS) with a dedicated EDS generator mode for vessels with diameter 2-6 mm (squares), arteries (points) and veins (triangles) (b) Linear regression (solid line) of the seal and cut time and vessel diameter for the pooled group of arteries and veins.

Figure 4. Overall performance on a 5-point Likert scale of the Erbe Dissector (EDS; points) and ENSEAL G2 (EG2, diamonds) across surgical subtasks. Mean ± SD.

Figure 5. Intraoperative (a) and postoperative (b) performance aspects (median) for the Erbe Dissector (EDS; short-dashed line) and ENSEAL G2 (EG2; long‑dashed line) by four operators. 5 =Very good; 4 =Good; 3 =Neutral; 2 =Poor; 1 =Very poor.

Data availability statement

The data presented in this study are available on reasonable request from the corresponding author.