Trial document





This trial has been registered retrospectively.
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  DRKS00016025

Trial Description

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Title

Navigation in Laparoscopic Soft Tissue Surgery - A prospective study evaluating the feasibility, safety and efficacy of nephrolithotomy

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Trial Acronym

iPAD PCNL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Kidney stones are one of the most common diseases in today's society. The therapy depends on the size and location of the stone as well as the clinic and laboratory parameters of the patient. The use of extracorporeal shockwave lithotripsy, and in particular endourological techniques such as flexible and rigid ureterorenoscopy and percutaneous nephrolithotomy, has revolutionized the treatment of urinary stone disease. The quality of percutaneous nephrolithotomy depends crucially on an exact puncture of the renal pelvic cyst. This is performed as standard by an ultrasound-controlled technique in combination with fluoroscopy. With both methods, only an incomplete representation of the surrounding anatomy is possible, which on the one hand limits the accuracy of the puncture and on the other hand can lead to puncture-related injuries of adjacent organs.
The idea for iPAD-assisted navigation is based on the idea of ​​looking inside the body using virtual reality. Using the iPAD requires a preoperative computed tomogram with radiopaque markers on the body surface. These CT images are then segmented and transmitted via special WIFI software from the central computer to the iPAD. The iPAD serves as a camera, computer and display for displaying the three-dimensional anatomy of the patient.
After establishing a renal puncture model, this new method was first examined in vitro. After technical optimization, this technique should also be implemented in a clinical study for percutaneous renal puncture before nephrolithotomy.
Study participants are patients with large kidney stones with the indication for percutaneous stone removal.

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Brief Summary in Scientific Language

Comparative study of a new technique for percutaneous navigated renal puncture prior to PCNL for stone removal for standard ultrasound and fluoroscopy guided puncture.

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Organizational Data

  •   DRKS00016025
  •   2018/12/13
  •   [---]*
  •   yes
  •   Approved
  •   S-666/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N20.0 -  Calculus of kidney
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Interventions/Observational Groups

  •   iPAD navigated PCNL (Percutaneous nephrolithotomy)
  •   Sonographic/Fluoroscopic guided PCNL (cases out of a database to be used in the matched pair analyses)
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Puncture time, radiation exposure, puncture attempts to a successful puncture

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Secondary Outcome

complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/09/30
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Patients with larger kidney stones scheduled according to the percutaneous stone removal guidelines who have informed and consented to the study.

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Exclusion Criteria

Minors or non-self-consenting patients, as well as pregnant women

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Addresses

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    • Universitätsmedizin Mannheim Urologische Klinik
    • Theodor-Kutzer-Ufer 1-3
    • 68161  Mannheim
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsmedizin Mannheim Urologische Klinik
    • Ms.  Dr.  Marie-Claire  Rassweiler-Seyfried 
    • Theodor-Kutzer-Ufer 1-3
    • 68161  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim Urologische Klinik
    • Ms.  Dr.  Marie-Claire  Rassweiler-Seyfried 
    • Theodor-Kutzer-Ufer 1-3
    • 68161  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/04/24
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.