Robotic-assisted Percutaneous Access
Condition: Kidney Stone
MeSH terms: Kidney Calculi
Study type: Interventional

Summary: 
      This is a first-in-man (FIM) study to show feasibility and safety profile of the newly
      developed robotic device for percutaneous access in PCNL surgery. Patients with renal stone
      disease who had standard indications for prone PCNL were included in the study. PCNL was
      conducted with percutaneous puncture with the aid of robotic device with the use of
      intra-operative fluoroscopy. 5 patients were recruited in this pilot study over a period of 3
      months. Punctures were performed by the board-qualified urologist.
    

Detailed description: 
      All patients underwent preoperative investigations and imaging study (CT Urogram/Intravenous
      Pyelography) done prior to the operation as per standard operation preparation.
      Intraoperatively fluoroscopic imaging was done for the patients and the images were
      synchronized to the software. Robotic arm was placed on the site of surgery as for prone PCNL
      and diaphragm of the arm was centred over the site of desire calyx of entry. A needle was
      engaged into the centre of the diaphragm and using the software the need was aligned in the
      line of puncture automatically based on the fluoroscopic images. After the alignment was done
      the needle was advanced manually by the surgeon until the entry was confirmed by efflux of
      urine from the puncture needle. After the entry was confirmed a standard PCNL using 24 F or
      30 F Balloon dilator was performed and stone cleared using Cyberwand/ Shockpulse etc. All the
      intraoperative and perioperative parameters as mentioned in the data collection form was
      measured. Results was analysed with the main focus on time of obtaining the puncture,
      accuracy of puncture, radiation exposure time till calyceal entry which was confirmed by free
      flow of urine and for any complications.

      Patients aged between 21 to 75 years old who were diagnosed with kidney stone diseas and
      planned for prone PCNL with indication for surgery as per standard of care were recruited.
      They understood the purpose of testing and offered their voluntary and informed consent.

      The robotic device i.e. ANT lesses the learning curve of percutaneous access as it reduces
      the need for surgeon's visualization of the calyceal system and the needle alignment. It also
      improved efficiency as there is less dependence on human skills during the procedure. As a
      whole, the FIM trial was a success. The performance of the ANT system during the trial was
      satisfactory. The robot alignment time is less than 30 seconds. Total puncture time was
      around 6 minutes and no AEs were reported.
    

Intervention name(s): PCL under fluoroscopy with the aid of the robotic device
Intervention type(s): Device
Intervention description(s): During the surgery, the robot was positioned over the estimated insertion point. It was aligned to be parallel to the fluoroscope imaging plane as much as possible. The needle is to be placed through the holder, and slightly penetrate the surface of the skin. An x-ray image is then taken to ensure that the whole device can be seen on the screen. Image calibration is then performed through the software GUI. After which, the clinician is also to perform needle tip selection. After which, needle alignment will then be performed. Once needle alignment is complete, the clinician will then advance the trocar needle into the patient's body, using the fluoroscopy to judge the penetration depth. Once the target has been reached, the needle style is to be extracted. The indication of leakage of fluid through the outer needle confirms the success of the procedure.
Intervention model: Single Group Assignment
Intervention model description: Recruitment was carried out in University Malaya Medical Centre (UMMC) Hospital clinics and impatient wards. 5 patients were recruited with no preferred selection for gender or race. Patients recruited were set to be between 21 to 75 years of age.
Patients presenting to to clinic or admitted to ward for renal stone disease were assessed for indications of PCNL. Patients were assessed for renal stone disease as per standard of care - imaging study with CT scan, renal function, clinical assessment of fitness and suitability for prone PCNL.
Once patients were planned for prone PCNL, they will be informed about this study, the use of robotic device, potential benefits and complications by study investigators. If they are agreeable to informed consent, they will be recruited into the study.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: PCNL; Percutaneous nephrolithotomy