HARP II-trial: Right-sided hand-assisted retroperitoneoscopic live donor nephrectomy versus standard laparoscopic living donor nephrectomy.

Transplantation is the only treatment offering long-term benefit to patients
with chronic kidney failure. As the number of patients suffering end stage
renal disease (ESRD) increases, the recruitment of more kidney donors is
important. Live kidney donation is the most realistic option to reduce donor
shortage on short- and long-term. Increasing the number of donors will decrease
the number of patients on the waiting list and consequently reduce patient*s
mortality. Implementation of live donation offers the possibility to transplant
before the kidney disease reaches the terminal phase, necessitating dialysis.
Thus, this so called pre-emptive transplantation may prevent unnecessary
surgical interventions to establish dialysis (including costs and mortality)
and dialysis related complications. In the last decade the number of
non-related live kidney donations is rising. Among these donors are family and
friends of the recipient, and even anonymous donors; the ethical basis for live
kidney donation is altering. The looser the connection between the donor and
recipient is, the less clear the profit for the donor is.
Live donor nephrectomy is performed on healthy individuals who do not receive
direct therapeutic benefit of the procedure themselves. In order to guarantee
safety for the donors, it is important to optimise the surgical approach.
Recently we demonstrated the benefit of laparoscopic nephrectomy (LDN) to the
donor. However, this method is characterised by higher in-hospital costs,
longer operating times and requires a well-trained surgeon. The hand-assisted
retroperitoneoscopic technique (HARP-technique) may be an alternative to a
complete laparoscopic, transperitoneal approach. The peritoneum remains intact
and the risk of visceral injuries is reduced. The hand-assistance results in a
faster procedure and a significantly reduced operating time. The feasibility of
this method has been demonstrated recently, but as to date studies advocating
the use of one technique above the other are lacking. This randomised
controlled trial compares the right-sided hand-assisted retroperitoneal
approach to the current standard, the transperitoneal laparoscopic technique,
to define the most optimal approach.
We recently proved that laparoscopic kidney donation is beneficial for the
donor. In comparison to minimally invasive open techniques, laparoscopic kidney
donation is associated with a better quality of life, less pain, shorter in
hospital stay and earlier return to work. This method is expensive for the
hospital, has a long operating time and requires an experienced, well-trained,
surgeon. Other studies showed a possibly increased rate of 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 (i.e.
selection of donors is not required) with similar benefits as the
transperitoneal laparoscopic approach is warranted.
The right-sided hand-assisted retroperitoneoscopic approach may be a viable
alternative. With this method the surgeon inserts his hand to create a
retroperitoneal space, which is thereafter insufflated with gas. The peritoneum
stays intact and tactile sensation remains. The chance of a complication to the
intestines is very small. Furthermore, this technique is easier and quicker to
learn for the surgeon than the laparoscopic approach. In the Erasmus MC we
perform a randomised trial to compare these techniques for left-side donor
nephrectomy (HARP-trial). We also want to know if the operation time is
diminished in the right-sided donor nephrectomy, as this is not discribed in
literature.

To determine the best approach for right-sided live donor nephrectomy i.e. to
optimise donor*s safety and comfort .

The HARP II-trial is a single-centre, randomised controlled, single-blind
trial. The study compares hand-assisted retroperitoneoscopic donor nephrectomy
and standard laparoscopic donor nephrectomy for the right-sided approach. In
total 40 live kidney donors will be included in the study.
Randomisation will take place after endotracheal intubation, by means of
telephonic consultation of the study coordinator. A computer generated
randomisation list with hidden block size is made for each centre by the
statistician. The donor and the physicians involved in the postoperative period
are blinded to the surgical technique until one year after donor nephrectomy.
The operating theatre is not accessible for people who do not join the
operating team. An independent surgeon evaluates the donor on the outpatient
clinic before operation. As the extraction incision is similar in both
techniques, we did not attempt to cover the wounds with a standard pattern of
bandages [12]. All donors fill out the questionnaires until one year after
donation, the Short-form 36 (SF-36), Euroqol (EQ-5D), Visual Analogue Scale
(VAS) and a questionnaire about work and homecare.

Patient selection
All, properly Dutch speaking, live kidney donors who are medically capable of
donating their left kidney can be included in the HARP II-trial. Informed
consent is mandatory. All types of live kidney donors can participate in the
study, i.e. related, unrelated, altruistic and cross-over live kidney donors.
Exclusion criteria are a history of kidney surgery or adrenal gland surgery on
the right side.

All potential donors are informed about the study at the outpatient clinic. For
further information the patient can refer to the research fellow, transplant
surgeon, or the independent physician. If a patient does not sign the informed
consent form, the patient is not included in the study and therefore will be
operated via the standard protocol. A live kidney donor can always withdraw his
or her consent at anytime during the study.

Both procedures were performed with the donor placed in right-decubitus
position. LDN was performed as described earlier. Shortly, a 10-mm trocar was
introduced under direct vision. The abdomen was insufflated carbon dioxide to
12 cm H2O pressure. A 30º video endoscope and 3 to 4 additional trocars were
introduced. The colon was mobilized and displaced medially. Opening of the
renal capsule and division of the perirenal fat was facilitated using an
ultrasonic device (Ultracision, Ethicon, Cincinnati, USA). After identification
and careful dissection of the ureter, the renal artery and the renal vein, a
pfannenstiel incision was made. An endobag (Endocatch, US surgical, Norwalk,
USA) was introduced into the abdomen. The ureter was clipped distally and
divided. The renal artery and vein were divided using an endoscopic stapler and
the kidney was placed in the endobag and extracted through the pfannenstiel
incision.

In HARP we started with a 7-10 cm pfannenstiel incision. After blunt dissection
to create a retroperitoneal space, the Gelport (Applied Medical, Rancho Santa
Margarita, California, USA) was inserted. Blunt introduction of the first
trocar between the iliac crest and the handport was guided by the operator*s
hand inside the abdomen. CO2 was insufflated retroperitoneally to 12 cm H2O
pressure. Two other 10-12 mm trocars, respectively just outside the midline
inferior to the costal margin and in the flank, were inserted to create a
triangular shape. For dissection the aforementioned ultrasonic device was used.
Dissection of the kidney and renal vessels was similar to transperitoneal donor
nephrectomy but with hand-assistance and from a slightly different angle. The
kidney was removed manually.

3 hours, for filling ou the questionnaires