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Donor NephrectomyHAPERPACTNCT03317184

Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision

A study testing Periumbilical incision and Pfannenstiel incision in people with Donor Nephrectomy, run by University Hospital Heidelberg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Donor Nephrectomy
What is being tested?
Periumbilical incision and Pfannenstiel incision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteGermany
Study dates
1 Nov 2017to 1 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting
  • Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Arianeb Mehrabi, MD, 0049 - 6221 - 5636223, arianeb.mehrabi@med.uni-heidelberg.de

    Recruiting

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Periumbilical incision, Pfannenstiel incision
Keywords
Physical Activity, Pfannenstiel incision, Periumbilical incision
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periumbilical incisionProcedure or surgery

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

  • Pfannenstiel incisionProcedure or surgery

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

Study groups in NCT03317184
Study groupRoleWhat they receive
Periumbilical incisionsExperimentalNot described
Receives: Procedure: Periumbilical incision
Pfannenstiel incisionExperimentalNot described
Receives: Procedure: Pfannenstiel incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days to return to normal physical activity

    Patients 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.

    Measured: Four weeks

Secondary outcomes (19)
  1. Warm ischemia time

    From the time of clamping of the first renal artery in situ to flushing of the kidney with chilled solution on the back table

    Measured: One day

  2. Intraoperative complications

    From skin incision to skin closure

    Measured: One day

  3. Estimated blood loss

    From skin incision to skin closure

    Measured: One day

  4. Operating time

    From skin incision to skin closure

    Measured: One day

  5. Postoperative pain

    Severity of pain via 11-point Visual Analogue Scale (0 = no pain and 10 = unbearable distress).

    Measured: Seven days

  6. Rescue analgesic

    Total amount of analgesics required.

    Measured: Seven days

  7. Peak expiratory flow rate

    Is defined as maximum speed of expiration, as measured with a peak flow meter.

    Measured: Seven days

  8. Postoperative complications

    According to the Clavien-Dindo classification

    Measured: 60 days

  9. Length of hospital stay

    From the day of the operation until the day of discharge

    Measured: 60 days

  10. Time to return to work

    From the day of discharge and return to work

    Measured: 60 days

  11. Physical activity score

    The 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.

    Measured: 60 days

  12. Patient satisfaction

    Patient satisfaction score via 5-point Likert scale (5 = representing strongly satisfied and 1 = representing strongly unsatisfied).

    Measured: 60 days

  13. Cosmetic score

    As 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).

    Measured: 60 days

  14. Incisional hernia

    Defined 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.

    Measured: 60 days

  15. Mortality

    Death due to any cause.

    Measured: 60 days

  16. Recipient serum creatinine level

    Serum creatinine level (mg/dL)

    Measured: 30 days

  17. Glomerular filtration rate

    GFR (mL/min/1.73 m2) calculated with "175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female)" Formula

    Measured: 30 days

  18. Delayed graft function

    Is defined as the need for one or more hemodialysis treatments following transplantation prior to the onset of graft function.

    Measured: 30 days

  19. Primary non-function

    A recipient whose graft never functions.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start1 Nov 2017
  3. Primary completion1 Feb 2020 (estimated)
  4. Study completion1 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Expertise-based, single intuition, assessor-blinded, randomized clinical trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317184
Sponsor's protocol ID
S-291/2017
Acronym
HAPERPACT
Status last verified
May 2018
First submitted
6 Oct 2017
Last updated
14 May 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30005640

Questions about this trial

What is this clinical trial studying?

A study testing Periumbilical incision and Pfannenstiel incision in people with Donor Nephrectomy, run by University Hospital Heidelberg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yakup Kulu, MD (0049 - 6221 - 5637215, Yakup.Kulu@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days to return to normal physical activity (time frame: Four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317184, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.

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