Skip to content

Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision

Hand-Assisted Laparoscopic Donor Nephrectomy PERiumbilical Versus Pfannenstiel Incision and Return to Normal Physical ACTivity: A Randomized Clinical Trial: HAPERPACT Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03317184
Acronym
HAPERPACT
Enrollment
52
Registered
2017-10-23
Start date
2017-11-01
Completion date
2020-06-01
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Donor Nephrectomy

Keywords

Physical Activity, Pfannenstiel incision, Periumbilical incision

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.

Interventions

PROCEDUREPeriumbilical incision

A periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy.

Pfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis for hand-assisted laparoscopic donor nephrectomy.

Sponsors

University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Expertise-based, single intuition, assessor-blinded, randomized clinical trial.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Days to return to normal physical activityFour weeksPatients will be asked to complete the Katz basic activities of daily living self-maintenance questionnaire each day for 4 weeks after the operation. This questionnaire assesses the ability to perform daily living activities (0 = no activity and 6 = normal activity). The normal physical activity is perceived as good.

Secondary

MeasureTime frameDescription
Intraoperative complicationsOne dayFrom skin incision to skin closure
Estimated blood lossOne dayFrom skin incision to skin closure
Operating timeOne dayFrom skin incision to skin closure
Postoperative painSeven daysSeverity of pain via 11-point Visual Analogue Scale (0 = no pain and 10 = unbearable distress).
Rescue analgesicSeven daysTotal amount of analgesics required.
Peak expiratory flow rateSeven daysIs defined as maximum speed of expiration, as measured with a peak flow meter.
Postoperative complications60 daysAccording to the Clavien-Dindo classification
Length of hospital stay60 daysFrom the day of the operation until the day of discharge
Time to return to work60 daysFrom the day of discharge and return to work
Warm ischemia timeOne dayFrom the time of clamping of the first renal artery in situ to flushing of the kidney with chilled solution on the back table
Patient satisfaction60 daysPatient satisfaction score via 5-point Likert scale (5 = representing strongly satisfied and 1 = representing strongly unsatisfied).
Cosmetic score60 daysAs defined by the Stony Brook scar scale (SBSES). The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).
Incisional hernia60 daysDefined as a fascia or muscle defect (bulging hernial sac and palpable fascia gap) at the site of the surgical incision examined by palpation and ultrasonography.
Mortality60 daysDeath due to any cause.
Recipient serum creatinine level30 daysSerum creatinine level (mg/dL)
Glomerular filtration rate30 daysGFR (mL/min/1.73 m2) calculated with 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) Formula
Delayed graft function30 daysIs defined as the need for one or more hemodialysis treatments following transplantation prior to the onset of graft function.
Primary non-function30 daysA recipient whose graft never functions.
Physical activity score60 daysThe International Physical Activity Questionnaire, Short Form (IPAQ) will be used as an indicator of physical activity and fitness. IPAQ assesses total physical activity in the previous 7 days. Questions measure the frequency (days per week) and duration (minutes per session) of physical activity, as well as its intensity level (vigorous, moderate, walking, or sitting). Participants are categorized into one of three physical activity levels (low, moderate, high). Range is not applicable because it is a categorical variable. The high activity category is perceived as good.

Countries

Germany

Contacts

Primary ContactYakup Kulu, MD
Yakup.Kulu@med.uni-heidelberg.de0049 - 6221 - 5637215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026