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CompletedNCT01819753Updated Mar 28, 2013

Assessment of the Effects of Access Count in Percutaneous Nephrolithotomy on Renal Functions by Technetium-99M-Dimercaptosuccinic Acid Scintigraphy

An interventional study of Percutaneous nephrolithotomy in Renal Parenchymal Loss After the Percutaneous Nephrolithotomy, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-03-28.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

In this study 37 patients who had undergone percutaneous nephrolithotomy were included. Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans were randomized by evaluating them before (n=25) and after (n=12) the 6th postoperative month. A DMSA scan was read by using a technique that divides both kidneys into three paired poles. In this way functional changes were investigated in the renal units. Twenty six of 37 cases underwent percutaneous nephrolithotomy with a single access site and 11 with multiple access sites. When each of the poles of a kidney was admitted as a surgical unit separately, there were 51 units.

Read the detailed description

Total 37 patients who had undergone PCNL were included between June 2007-June 2009. All patients were evaluated routinely with physical examination, complete blood count (CBC), blood urine nitrogen (BUN), creatinine levels, and urinalysis. None of the patients had experienced pyelonephritis, and none had a solitary kidney, renal ectopy or history of any other urinary abnormality. At least one of the following techniques; namely computed tomography (CT), intravenous urography or ultrasonography, was preferred routinely before surgery in order to visualize the urinary system. Unilateral PCNL was performed in all patients. Postoperative CBC and BUN creatine levels were repeated.

Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans were randomized to indicate early and late term. The aim of randomization was to determine an optimal time for assessing patients. A DMSA scan was read by using a technique that divides both kidneys into three paired poles. In addition the uptake of all opposite poles was measured together and calculated as a percentage value separately (Figure-1), e.g., the two upper poles' uptake was measured together as if they were renal units and each poles' own portion in this total uptake was declared separately as a percentage. How the differential functions were changed between the sides undergoing PCNL and the opposite sides, as well the changes before and 6 months after surgery are manifested by using these parameters.

Twenty six of 37 cases underwent PCNL with a single access site (70.3%) and 11 separately with multiple accesses (29.7%). When each of the poles of a kidney was considered as a surgical unit, there were 51 units. In this manner the functional change of a unit would show the surgical trauma inflicted on the poles by PCNL access.

02

Conditions studied

  • Renal Parenchymal Loss After the Percutaneous Nephrolithotomy

Keywords

  • percutaneous nephrolithotomy
  • urinary Stones
  • 99m-Technetium-Dimercaptosuccinic Acid
03

In context

Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with renal stones which was bigger than 2cm.

Exclusion criteria

Exclusion Criteria:

  • Patients with acute urinary tract infection,
  • Patients with bleeding disorder,
  • Patients with chronic renal failure,
  • Patients with solitary kidney, renal ectopy or history of any other urinary abnormality.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Single access

    It was performed only single access standard PCNL in this group.

    Procedure: Percutaneous nephrolithotomy

  • Active comparator
    Multiple access

    It was performed multiple access standard PCNL in this group

    Procedure: Percutaneous nephrolithotomy

Interventions

  • ProcedurePercutaneous nephrolithotomy

    The procedure is done under general anesthesia in the supine position. A Retrograde pyelogram is done to locate the stone in the kidney. With a small incision in the flank, the percutaneous nephrolithotomy (PCN) needle is passed into the pelvis of the kidney. The position of the needle is confirmed by fluoroscopy. A guide wire is passed through the needle into the pelvis. The needle is then withdrawn with the guide wire still inside the pelvis. Over the guide wire the dilators are passed and a working sheath is introduced. A nephroscope is then passed inside and stones are taken out.

06

What researchers measure

Primary outcomes

  1. Renal parenchymal function on DMSA before and after percutaneous nephrolithotomy.

    Preoperative DMSA scans were performed a day before percutaneous nephrolithotomy.How the differential functions with DMSA scans were changed between the sides undergoing PCNL and the opposite sides, as well the changes before and 6 months after surgery are manifested by using these parameters.

    Time frame: six months

07

Study locations

1 site
  • Erciyes University Faculty of Medicine.
    Kayseri, 38039, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01819753
Lead sponsor
TC Erciyes University
Responsible party
Abdullah Demirtas (Assistant Professor., MD, TC Erciyes University) — Principal investigator
First posted
Mar 28, 2013
Start date
Jun 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Mar 28, 2013

Study contacts

Abdullah Demirtaş, Assistant Prof., MD
study chair · Department of Urology, Erciyes University Faculty of Medicine, Kayseri, Turkey.
View the source record on ClinicalTrials.gov ↗

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