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.
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
- 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
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.
- Conditions
- Donor Nephrectomy
- 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 group | Role | What they receive |
|---|---|---|
| Periumbilical incisions | Experimental | Not described Receives: Procedure: Periumbilical incision |
| Pfannenstiel incision | Experimental | Not described Receives: Procedure: Pfannenstiel incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Intraoperative complications
From skin incision to skin closure
Measured: One day
Estimated blood loss
From skin incision to skin closure
Measured: One day
Operating time
From skin incision to skin closure
Measured: One day
Postoperative pain
Severity of pain via 11-point Visual Analogue Scale (0 = no pain and 10 = unbearable distress).
Measured: Seven days
Rescue analgesic
Total amount of analgesics required.
Measured: Seven days
Peak expiratory flow rate
Is defined as maximum speed of expiration, as measured with a peak flow meter.
Measured: Seven days
Postoperative complications
According to the Clavien-Dindo classification
Measured: 60 days
Length of hospital stay
From the day of the operation until the day of discharge
Measured: 60 days
Time to return to work
From the day of discharge and return to work
Measured: 60 days
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
Patient satisfaction
Patient satisfaction score via 5-point Likert scale (5 = representing strongly satisfied and 1 = representing strongly unsatisfied).
Measured: 60 days
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
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
Mortality
Death due to any cause.
Measured: 60 days
Recipient serum creatinine level
Serum creatinine level (mg/dL)
Measured: 30 days
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
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
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.
- First posted23 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Donor NephrectomyStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A. Mehrabi, University Hospital Heidelberg
- Investigators
- Yakup Kulu, MD, Principal investigator, Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, GermanyArianeb Mehrabi, MD, Study director, Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand-Assisted Laparoscopic Donor Nephrectomy PERiumbilical Versus Pfannenstiel Incision and Return to Normal Physical ACTivity: A Randomized Clinical Trial: HAPERPACT Trial
- ClinicalTrials.gov ID
- NCT03317184
- Acronym / sponsor ID
- HAPERPACT / S-291/2017
- Conditions
- Donor Nephrectomy
- Keywords
- Physical Activity, Pfannenstiel incision, Periumbilical incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Expertise-based, single intuition, assessor-blinded, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Periumbilical incisions | Experimental | Procedure: Periumbilical incision |
| Pfannenstiel incision | Experimental | Procedure: Pfannenstiel incision |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 20 years
- No permanent pain therapy
- Kidneys with only a single artery and vein in the graft
- Informed consent for participation provided
Key exclusion criteria (3 listed)
- Infection or scar present precluding incision placement at one of the randomization sites
- Bleeding disorders
- Chronic use of immunosuppressive agents (e.g. steroids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periumbilical incisionA periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy. | Procedure or surgery | Periumbilical incisions |
| Pfannenstiel incisionPfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis for hand-assisted laparoscopic donor nephrectomy. | Procedure or surgery | Pfannenstiel incision |
Primary outcome
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.
19 secondary outcomes
Warm ischemia time
Time frame: One day
Intraoperative complications
Time frame: One day
Estimated blood loss
Time frame: One day
Operating time
Time frame: One day
Postoperative pain
Time frame: Seven days
Rescue analgesic
Time frame: Seven days
Peak expiratory flow rate
Time frame: Seven days
Postoperative complications
Time frame: 60 days
Length of hospital stay
Time frame: 60 days
Time to return to work
Time frame: 60 days
Physical activity score
Time frame: 60 days
Patient satisfaction
Time frame: 60 days
Cosmetic score
Time frame: 60 days
Incisional hernia
Time frame: 60 days
Mortality
Time frame: 60 days
Recipient serum creatinine level
Time frame: 30 days
Glomerular filtration rate
Time frame: 30 days
Delayed graft function
Time frame: 30 days
Primary non-function
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 30005640Kulu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yakup Kulu, MD principal investigator
Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
Arianeb Mehrabi, MD study director
Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
1 site in 1 country: see every site and its status.
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.