This study focuses on feasibility and safety of 3D laparoscopic donor nephrectomy during the dissection of the renal artery and vein.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde nierdonoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Duration of dissecting the renal artery and vein, and their branches.
Secondary outcome
Multiple vascular anatomy, kidney function (eGFR), total operation time,
quality of life, pain scores, intra- and postoperative complications, length of
hospital stay and costs.
Background summary
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 optimize the surgical approach. The first laparoscopic live
donor nephrectomy was performed by Ratner et al. in 1995 (1). Compared 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 (2).
During the development of the surgical techniques the minimal invasive LDN
procedure has remained the same, except from the extraction site of the kidney.
Offering 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.
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.
With the introduction of this new technique to safely procure a donor kidney,
the surgeon*s armamentarium got expanded and now this technique has been widely
accepted as the first choice of treatment. However, with this technique, the
surgeon*s lost their 3D vision and hand/wrist movements. The Da Vinci robot has
been designed to improve upon conventional laparoscopy by giving these
functions back to the surgeon with 540º degrees wrist movements of the
instruments instead of 180º and 3D vision for the surgeon only. However, the
DaVinci robot is quite expensive in purchase and maintenance, and requires
extra training of surgeons to get DaVinci certified.
Two of our surgeons are DaVinci certified surgeons whom perform robot-assisted
LDN. During these procedures a special operating team of nurses and surgeons is
needed who have experience with the DaVinci robot. Furthermore the DaVinci
robot is shared with other specialties. Both conditions make it impossible to
operate all live kidney donors with the DaVinci robot.
In our center 2D-laparoscopic LDN is the treatment of choice for live donor
nephrectomy for the past 15 years. Our surgeons perform over 130 laparoscopic
LDN per year and have been excellent trained in this procedure. The
two-dimensional images on the monitor certainly have their disadvantages.
Three-dimensional laparoscopy was introduced in the 1990s, but with the latest
developments of better monitors and high definition, it has started to become
established in the operating rooms (3, 4). With the implementation of
three-dimensional images on the monitor during laparoscopy, we would like to
combine our expertise in LDN with 3D vision; enabling 3D vision for the
surgeon, but also for the assisting surgeon and nurse. Since we*re only adding
a 3D camera, no extra training or certificate is required for our transplant
surgeons. This way, we will be able to increase the number of live kidney
donors who will undergo a 3D procedure and subsequently maximize donor safety.
Study objective
This study focuses on feasibility and safety of 3D laparoscopic donor
nephrectomy during the dissection of the renal artery and vein.
Study design
The 3D LDN study is a single center prospective study. Live kidney donors will
be included to evaluate if addition of a 3D camera is feasible for donor
nephrectomy.
Intervention
Three-dimensional donor nephrectomy will be performed using the Olympus EndoEye
Flex 3D 10 mm camera and Sony LMD-2451MT/TG 3D monitor. The patient is placed
in lateral decubitus position. Four trocars are used; two laparoscopic ports
for instruments of the operating surgeon and two laparoscopic ports for the
assisting surgeon for one instrument and the 3D camera. The nephrectomy will be
carried out in the same way as the conventional 2D laparoscopic procedure. The
donor is positioned in right lateral decubitus position. Then, the first trocar
is inserted periumbilically and a pneumoperitoneum is created by CO2
insufflation, after which a 30° video-endoscope is introduced and three
additional trocars are inserted. The left hemicolon is dissected from the
lateral abdominal wall and mobilized medially. Gravity aids the further
mobilisation. The kidney is located behind the hepatic or splenic flexure.
Gerota*s fascia is opened and the kidney is exposed from a varying amount of
surrounding perirenal fat. Next, the ureter is exposed until it crosses the
gonadal vein. The renal vessels are dissected and encircled with red or blue
vessel loops to facilitate identification of the artery and vein from different
directions, respectively. The vessel loops also enable safe manipulation of the
vessels during the hilar dissection. The venous branches of the renal vein,
especially in case of left sided donor nephrectomy, are clipped and divided
with scissors. When the kidney, ureter, vein and artery are all fully
dissected, a 5 to 8 cm horizontal suprapubic incision or Pfannenstiel incision
is made as extraction site, while maintaining pneumoperitoneum. An endobag is
introduced via a small incision in the peritoneum. Subsequently, the distal
ureter is clipped and divided with scissors, secondly the renal artery is
divided with an endostapler and last the renal vein is divided with an
endostapler. The kidney is placed in the endobag and extracted via the
incision. 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.
Study burden and risks
Burden of 2 hours maximum, filling out questionnaires.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All, properly Dutch speaking, live kidney donors who are medically capable of donating one of their
kidneys can be included.
Exclusion criteria
A history of kidney surgery or adrenal gland surgery on the side chosen for
surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL49790.078.14 |