Donor Nephrectomy Clinical Trial
Official title:
Hand-Assisted Laparoscopic Donor Nephrectomy PERiumbilical Versus Pfannenstiel Incision and Return to Normal Physical ACTivity: A Randomized Clinical Trial: HAPERPACT Trial
Despite efforts to optimize the transplantation of deceased donor kidneys, the number of available kidneys continues to fall short of the demand. Living donor kidneys have been used to overcome this shortage. Graft and patient survival is significantly higher following living donor kidney transplantation compared with deceased donor kidney transplantation. Open donor nephrectomy was the universal technique prior to the advent of laparoscopic techniques. Laparoscopic approaches have definite advantages over open surgery in terms of blood loss, postoperative pain, analgesic requirements, duration of hospital stay, and convalescence. There is some controversy regarding longer warm ischemia time, longer operative time, and increased bleeding with laparoscopic nephrectomy compared with hand-assisted laparoscopic living donor nephrectomy (HALDN). HALDN attempted to reduce warm ischemia time by using the hand port to extract the kidney instantly after dividing the blood vessels. This technique also offers tactile feedback, better manual control of bleeding, a relatively shorter learning curve, less kidney traction, faster kidney removal, and shorter warm ischemic periods. HALDN is often performed using periumbilical and Pfannenstiel incisions for hand-assisted port placement. Pfannenstiel incisions improve wound complications such as incisional hernia, cosmetic issues, and wound dehiscence. However, duration of surgery, postoperative pain score, and length of hospital stay are significantly lower in donors with periumbilical incisions.To the best of our knowledge, these two types of incision have not been compared in a randomized controlled trial in patients undergoing HALDN. Our objective is to compare the results of Pfannenstiel incision (intervention group) with periumbilical incision (control group). The return to normal physical activity will be evaluated in a clinical randomized trial using an expertise-based design.
Despite all efforts to optimize the transplantation of deceased donor kidneys, the number of
available kidneys continues to fall short of demand. Living donor kidneys have been used to
overcome this organ shortage. Graft and patient survival is significantly higher following
living donor kidney transplantation compared with deceased donor kidney Transplantation.
The major disadvantage of using living donors is that a healthy individual must undergo a
major surgical procedure to provide the organ for transplantation. The donor does not
medically benefit from the procedure, but there is a medical impact on both donor and
recipient. Therefore, a nephrectomy technique associated with the lowest donor risk and the
best organ quality should be used during Transplantation.
Open donor nephrectomy was the universal technique before the advent of laparoscopic
techniques. Laparoscopic living donor nephrectomy was introduced in 1995 and commercial ports
were developed shortly after. In 1998, Wolf et al. described the hand-assisted laparoscopic
living donor nephrectomy (HALDN) technique and since then it has become widely adopted.
Laparoscopic methods have definite advantages over open surgery in terms of blood loss,
postoperative pain, analgesic requirements, duration of hospital stay, and convalescence.
There is some controversy regarding the possibility of relatively longer warm ischemia time,
longer operative time, and increased bleeding with laparoscopic nephrectomy. HALDN reduces
warm ischemia time by extracting the kidney using the hand port as soon as the blood vessels
are divided. This technique is associated with tactile feedback, better manual control of
bleeding, relatively shorter learning curve, less kidney traction, faster kidney removal, and
shorter warm ischemic periods. At present, there is no strong evidence to support the use of
one laparoscopic approach in preference to the other. However, evidence suggests that HALDN
is the most cost-effective method of donor surgery and achieves equivalent clinical benefits
of pure laparoscopic approaches with less operative time.
HALDN is usually performed using a periumbilical or Pfannenstiel incision for hand-assisted
port placement and kidney extraction. A periumbilical incision is made at the midline. In
contrast, a Pfannenstiel incision is made as a slightly curved horizontal line just above the
pubic symphysis. Pfannenstiel incisions improve wound complications, such as incisional
hernia, cosmetic results, and wound dehiscence. However, the duration of surgery,
postoperative pain score, and length of hospital stay were significantly lower in donors with
periumbilical incision. The inserted hand plays a vital role in the procedure, including
retraction and dissection, therefore the hand port midline incision is placed close to the
periumbilical area. Dissecting the upper pole of the kidney through a Pfannenstiel incision
may be difficult in morbidly obese and large donors.
Patients with Pfannenstiel incisions return to normal physical activity quicker than those
with periumbilical incisions. However, to the best of our knowledge, these two different
incision types in patients undergoing HALDN have not been compared in a randomized controlled
trial.Our objective is to compare the return of patients to physical activity following a
HALDN procedure with Pfannenstiel incision (intervention group) or periumbilical incision
(control group) in a clinical randomized trial using an expertise-based design.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01925677 -
Robotic Single Port Donor Nephrectomy
|
N/A |