RoDo-trial: Visualisation and dissection during the hilar phase in robotic-assisted donor nepfrectomy.

Transplantation is the only treatment offering long-term benefit to patients
with chronic kidney failure. In the last decade a huge increase in the use of
living donors has been realized for renal transplantation. Live donor
nephrectomy is performed on healthy individuals who do not benefit directly
from the procedure themselves. In order to guarantee safety for the donor, it
is important to optimise the surgical approach. Recently we demonstrated the
benefit of laparoscopic nephrectomy (LDN) to the donor. In comparison to
minimally invasive open techniques, laparoscopic kidney donation is associated
with a better quality of life, less pain, shorter hospital stay and earlier
return to work. But this method demands experienced, well-trained surgeons who
have experienced a long learning curve. Less well-trained surgeons may have
more life threatening complications, such as injuries to the intestines and
bleeding. A surgical approach that is easier to learn and applicable in the
majority of donors with similar benefits and improved safety is warranted.
The Da Vinci Robot has been designed to improve upon conventional laparoscopy,
during which the surgeon operates while standing, using hand-held, long-shafted
instruments, without wrists. In conventional laparoscopy, the surgeon must look
up and away from the instruments, to a nearby 2D video monitor to see an image
of the target anatomy. The surgeon must also rely on the patient-side assistant
to position the camera correctly. In contrast, the Da Vinci System*s ergonomic
design allows the surgeon to operate from a seated position at the console,
with eyes and hands positioned in line with the instruments. To move the
instruments or to reposition the camera, the surgeon simply moves the hands,
using multifunctional joysticks. By providing surgeons with superior
visualization, enhanced dexterity because of an enhanced rotation angle of the
robotic wrists (540º vs. 180º in case of laparoscopic instruments being moved
by human hands), greater precision and ergonomic comfort, the Da Vinci Surgical
System makes it possible for more surgeons to perform minimally invasive
procedures involving complex dissection or reconstruction. Furthermore, the
surgeon being educated for this procedure may be assisted by a co-operator who
may help and instruct directly. For the donor a robotic-assisted procedure can
offer all the potential benefits of a minimally invasive procedure, including
less pain, less blood loss and less need for blood transfusions while safety is
increased. Moreover, it can enable a shorter hospital stay, a quicker recovery
and faster return to normal day activities.

LDN is among the few endoscopic surgical procedures in which the great
abdominal vessels are in the operation field. A significant percentage of the
total blood volume passes the large renal vessels every minute. These vessels
have to be preserved to allow proper placement in the recipient without
compromising the donor*s safety. The two-dimensional images on the monitor
certainly have their disadvantages. Misjudging accessory renal arteries may
result in complications in the recipient. Misjudging aberrant renal veins,
gonadal veins, adrenal veins and arteries may lead to serious (sometimes life
threatening) bleeds during nephrectomy. It will be obvious that anatomical
variations in the renal hilum, including multiple arteries, veins and branches
demand accurate surgical techniques and that the robotic-assisted procedure and
especially 3D imaging may facilitate the safety of the procedure in the
vascular phase.

For the laparoscopic cholecystectomy, safety for the patient is improved
drastically by applying the Critical View of Safety (CVS). To avoid
intraoperative complications, a simple step was introduced. All surgeons were
required to take a picture of the most important step in the operation. An
adapted form of this step will be used for the robotic-assisted donor
nephrectomy. In this study we will investigate the CVS as well as other steps
by monitoring all procedures with an adapted form of *Hierarchical Task
Analysis*. This safety checklist will be used to study generic and specific
technical skills of the surgeons per protocol and to determine donor safety.
In advance of working with the robot two staff surgeons already visited an
international training course to get acquainted with and certified for this way
of working. To date, 7 donors have been operated successfully by using the
robot in the Erasmus MC. These operations were used to train the assisting
OR-team and supervised by a proctor.

This pilot study focuses on feasibility and will answer questions on safety of
the procedure. Can a *Critical view of Safety* of the hilum of the kidney be
ascertained in all anatomical variations.The findings of this study will be
used to design a prospective randomized study, assessing the superiority of
either the robotic-assisted approach or the laparoscopic approach regarding
safety, costs and other donor-related factors.

The RODO-trial is a single-centre prospective study. In total 40 living kidney
donors will be included in 6-8 months and an additional follow-up of 3 months
is defined as the period to register post-operative complications. In this last
period the CVS and HTA analysis can be performed by an independent surgeon.

Robotic-assisted donor nephrectomy will be performed using the Da Vinci robot.
The patient is placed in lateral decubitus position. Four trocars are used;
three arms and the camera port are under direct control of the surgeon who is
seated in a distant console. Also, a laparoscopic port is being used by the
assistant surgeon. The images can be magnified and the movement of the
articulated arms of the robot, which have a rotation angle of 450°, will
reproduce the action of the human wrist with possibilities beyond the real
human hand movements. The nephrectomy will be carried out in the same way as
the laparoscopic procedure using a transverse lower abdominal incision to
extract the kidney. All procedures will be monitored during the entire
procedure for analysis of the primary outcome and can be controlled by others
to prevent observer-bias (CVA and Hierarchical Task Analysis).

No extra burden.