An interventional study of Periumbilical incision and Pfannenstiel incision in Donor Nephrectomy, sponsored by University Hospital Heidelberg. Status unknown at 1 site in Germany. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-14.
Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Treatment
Among 11 studies in Motor Activity by University Hospital Heidelberg — 1 open to participants now, 4 under way, none of them phase 3. Motor Activity · University Hospital Heidelberg.
Among the 11 studies in Motor Activity by University Hospital Heidelberg, this one is the 7th largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2017, is one of 9 with no phase, and was the 4th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →1 of the 11 studies in Motor Activity by University Hospital Heidelberg is open now, in 1 country. Recruiting first, the newest first:
University Hospital Heidelberg · Sites in Germany
By country, each count listing its studies:
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 20 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2017.
This study's planned enrollment of 52 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 103 across the 10 interventional studies, 800 across the 1 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
University Hospital Heidelberg is the lead sponsor of 177 studies on the registry; 48 are open to participants now.
1 of the studies in Motor Activity by University Hospital Heidelberg that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06185777University Hospital HeidelbergMulti-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients | 2027-03-01 |
Among the 11 studies in Motor Activity by University Hospital Heidelberg, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Periumbilical incision
Procedure: Pfannenstiel 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.
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.
Time frame: Four weeks
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
Time frame: One day
Intraoperative complications
From skin incision to skin closure
Time frame: One day
Estimated blood loss
From skin incision to skin closure
Time frame: One day
Operating time
From skin incision to skin closure
Time frame: One day
Postoperative pain
Severity of pain via 11-point Visual Analogue Scale (0 = no pain and 10 = unbearable distress).
Time frame: Seven days
Rescue analgesic
Total amount of analgesics required.
Time frame: Seven days
Peak expiratory flow rate
Is defined as maximum speed of expiration, as measured with a peak flow meter.
Time frame: Seven days
Postoperative complications
According to the Clavien-Dindo classification
Time frame: 60 days
Length of hospital stay
From the day of the operation until the day of discharge
Time frame: 60 days
Time to return to work
From the day of discharge and return to work
Time frame: 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.
Time frame: 60 days
Patient satisfaction
Patient satisfaction score via 5-point Likert scale (5 = representing strongly satisfied and 1 = representing strongly unsatisfied).
Time frame: 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).
Time frame: 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.
Time frame: 60 days
Mortality
Death due to any cause.
Time frame: 60 days
Recipient serum creatinine level
Serum creatinine level (mg/dL)
Time frame: 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
Time frame: 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.
Time frame: 30 days
Primary non-function
A recipient whose graft never functions.
Time frame: 30 days
Started Nov 2017 (actual). Primary completion is estimated for Feb 2020, 27 months after the start.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 27 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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