NCT01819753

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

March 25, 2013

Last Update Submit

March 27, 2013

Conditions

Keywords

percutaneous nephrolithotomyurinary Stones99m-Technetium-Dimercaptosuccinic Acid

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 COMPARATOR

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

Procedure: Percutaneous nephrolithotomy

Multiple access

ACTIVE COMPARATOR

It was performed multiple access standard PCNL in this group

Procedure: Percutaneous nephrolithotomy

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.

Multiple accessSingle access

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

Urinary Calculi

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Abdullah Demirtaş, Assistant Prof., MD

    Department of Urology, Erciyes University Faculty of Medicine, Kayseri, Turkey.

    STUDY CHAIR

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

Locations