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Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision (HAPERPACT)

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ClinicalTrials.gov Identifier: NCT03317184
Recruitment Status : Unknown
Verified May 2018 by Dr. A. Mehrabi, University Hospital Heidelberg.
Recruitment status was:  Recruiting
First Posted : October 23, 2017
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. A. Mehrabi, University Hospital Heidelberg

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.

Condition or disease Intervention/treatment Phase
Donor Nephrectomy Procedure: Periumbilical incision Procedure: Pfannenstiel incision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Expertise-based, single intuition, assessor-blinded, randomized clinical trial.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hand-Assisted Laparoscopic Donor Nephrectomy PERiumbilical Versus Pfannenstiel Incision and Return to Normal Physical ACTivity: A Randomized Clinical Trial: HAPERPACT Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Experimental: Periumbilical incisions Procedure: Periumbilical incision
A periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy.

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




Primary Outcome Measures :
  1. Days to return to normal physical activity [ Time Frame: Four weeks ]
    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.


Secondary Outcome Measures :
  1. Warm ischemia time [ Time Frame: One day ]
    From the time of clamping of the first renal artery in situ to flushing of the kidney with chilled solution on the back table

  2. Intraoperative complications [ Time Frame: One day ]
    From skin incision to skin closure

  3. Estimated blood loss [ Time Frame: One day ]
    From skin incision to skin closure

  4. Operating time [ Time Frame: One day ]
    From skin incision to skin closure

  5. Postoperative pain [ Time Frame: Seven days ]
    Severity of pain via 11-point Visual Analogue Scale (0 = no pain and 10 = unbearable distress).

  6. Rescue analgesic [ Time Frame: Seven days ]
    Total amount of analgesics required.

  7. Peak expiratory flow rate [ Time Frame: Seven days ]
    Is defined as maximum speed of expiration, as measured with a peak flow meter.

  8. Postoperative complications [ Time Frame: 60 days ]
    According to the Clavien-Dindo classification

  9. Length of hospital stay [ Time Frame: 60 days ]
    From the day of the operation until the day of discharge

  10. Time to return to work [ Time Frame: 60 days ]
    From the day of discharge and return to work

  11. Physical activity score [ Time Frame: 60 days ]
    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.

  12. Patient satisfaction [ Time Frame: 60 days ]
    Patient satisfaction score via 5-point Likert scale (5 = representing strongly satisfied and 1 = representing strongly unsatisfied).

  13. Cosmetic score [ Time Frame: 60 days ]
    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).

  14. Incisional hernia [ Time Frame: 60 days ]
    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.

  15. Mortality [ Time Frame: 60 days ]
    Death due to any cause.

  16. Recipient serum creatinine level [ Time Frame: 30 days ]
    Serum creatinine level (mg/dL)

  17. Glomerular filtration rate [ Time Frame: 30 days ]
    GFR (mL/min/1.73 m2) calculated with "175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female)" Formula

  18. Delayed graft function [ Time Frame: 30 days ]
    Is defined as the need for one or more hemodialysis treatments following transplantation prior to the onset of graft function.

  19. Primary non-function [ Time Frame: 30 days ]
    A recipient whose graft never functions.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317184


Contacts
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Contact: Yakup Kulu, MD 0049 - 6221 - 5637215 Yakup.Kulu@med.uni-heidelberg.de

Locations
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Germany
Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Arianeb Mehrabi, MD    0049 - 6221 - 5636223    arianeb.mehrabi@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Principal Investigator: Yakup Kulu, MD Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
Study Director: Arianeb Mehrabi, MD Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. A. Mehrabi, MD, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03317184    
Other Study ID Numbers: S-291/2017
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. A. Mehrabi, University Hospital Heidelberg:
Physical Activity
Pfannenstiel incision
Periumbilical incision
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries