Clinical trial NCT03317184: Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision
Official title: Hand-Assisted Laparoscopic Donor Nephrectomy PERiumbilical Versus Pfannenstiel Incision and Return to Normal Physical ACTivity: A Randomized Clinical Trial: HAPERPACT Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Donor Nephrectomy
Keywords: Physical Activity
Pfannenstiel incision
Periumbilical incision
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Expertise-based, single intuition, assessor-blinded, randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years
* No permanent pain therapy
* Kidneys with only a single artery and vein in the graft
* Informed consent for participation provided

Exclusion Criteria:

* Infection or scar present precluding incision placement at one of the randomization sites
* Bleeding disorders
* Chronic use of immunosuppressive agents (e.g. steroids)

Primary outcomes:
measure: Days to return to normal physical activity
timeFrame: Four weeks
Secondary outcomes:
measure: Warm ischemia time
timeFrame: One day
measure: Intraoperative complications
timeFrame: One day
measure: Estimated blood loss
timeFrame: One day
measure: Operating time
timeFrame: One day
measure: Postoperative pain
timeFrame: Seven days
measure: Rescue analgesic
timeFrame: Seven days
measure: Peak expiratory flow rate
timeFrame: Seven days
measure: Postoperative complications
timeFrame: 60 days
measure: Length of hospital stay
timeFrame: 60 days
measure: Time to return to work
timeFrame: 60 days
measure: Physical activity score
timeFrame: 60 days
measure: Patient satisfaction
timeFrame: 60 days
measure: Cosmetic score
timeFrame: 60 days
measure: Incisional hernia
timeFrame: 60 days
measure: Mortality
timeFrame: 60 days
measure: Recipient serum creatinine level
timeFrame: 30 days
measure: Glomerular filtration rate
timeFrame: 30 days
measure: Delayed graft function
timeFrame: 30 days
measure: Primary non-function
timeFrame: 30 days
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
name: Yakup Kulu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
name: Arianeb Mehrabi, MD
role: STUDY_DIRECTOR
References:
citation: Kulu Y, Muller-Stich BP, Ghamarnejad O, Khajeh E, Polychronidis G, Golriz M, Nickel F, Benner L, Knebel P, Diener M, Morath C, Zeier M, Buchler MW, Mehrabi A. Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial. Trials. 2018 Jul 13;19(1):377. doi: 10.1186/s13063-018-2775-4.