Assessment of the Effects of Access Count in Percutaneous Nephrolithotomy on Renal Functions by Technetium-99M-Dimercaptosuccinic Acid Scintigraphy
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedMarch 28, 2013
March 1, 2013
2 years
March 25, 2013
March 27, 2013
Conditions
Keywords
Outcome Measures
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.
six months
Study Arms (2)
Single access
ACTIVE COMPARATORIt was performed only single access standard PCNL in this group.
Multiple access
ACTIVE COMPARATORIt was performed multiple access standard PCNL in this group
Interventions
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.
Eligibility Criteria
You may qualify if:
- \- Patients with renal stones which was bigger than 2cm.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University Faculty of Medicine.
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Abdullah Demirtaş, Assistant Prof., MD
Department of Urology, Erciyes University Faculty of Medicine, Kayseri, Turkey.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor., MD
Study Record Dates
First Submitted
March 25, 2013
First Posted
March 28, 2013
Study Start
June 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 28, 2013
Record last verified: 2013-03