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

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT01819753
Collaborator
(none)
37
1
2
24
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous nephrolithotomy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Single access

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

Procedure: Percutaneous 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.

Active Comparator: Multiple access

It was performed multiple access standard PCNL in this group

Procedure: Percutaneous 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.

Outcome Measures

Primary Outcome Measures

  1. Renal parenchymal function on DMSA before and after percutaneous nephrolithotomy. [six months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with renal stones which was bigger than 2cm.
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erciyes University Faculty of Medicine. Kayseri Turkey 38039

Sponsors and Collaborators

  • TC Erciyes University

Investigators

  • Study Chair: Abdullah Demirtaş, Assistant Prof., MD, Department of Urology, Erciyes University Faculty of Medicine, Kayseri, Turkey.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abdullah Demirtas, Assistant Professor., MD, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT01819753
Other Study ID Numbers:
  • DMSAPCNL
First Posted:
Mar 28, 2013
Last Update Posted:
Mar 28, 2013
Last Verified:
Mar 1, 2013
Keywords provided by Abdullah Demirtas, Assistant Professor., MD, TC Erciyes University

Study Results

No Results Posted as of Mar 28, 2013