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Percutaneous Nephrolithotomy for Treatment of Kidney Stones Greater Than 2 cm

Primary Purpose

Renal Stone

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
percutaneous nephrolithotomy for kidney stones
Sponsored by
Dr Carlos Hernández
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone focused on measuring Percutaneous Nephrolithotomy, Postoperative Complications, Renal Stone, Surgical Success, Surgical Complications, Pneumatic Dilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient over 18 years old
  • Non-staghorn kidney stones greater than 2 cm

Exclusion Criteria:

  • Coagulopathies
  • Solitary Functioning Kidney
  • Pyonephrosis
  • Pregnancy
  • Urinary tract infection
  • Cardiopulmonary Restrictions Limiting Prone Position
  • BMI greater than 35
  • More of 2 puncture of the excretory tract
  • STONE score equal or greater than 12

Sites / Locations

  • Hospital Universitario Los Comuneros

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Percutaneous nephrolithotomy with Coaxial Dilatation

Percutaneous nephrolithotomy with Pneumatic Balloon

Arm Description

Percutaneous nephrolithotomy with Coaxial Dilatation for treatment of kidney stones greater than 2 cm.

Percutaneous nephrolithotomy with Pneumatic Balloon for treatment of kidney stones greater than 2 cm.

Outcomes

Primary Outcome Measures

Rate of intraoperative and postoperative complications that occur with the use of pneumatic dilation and with traditional coaxial dilatation.
To determine the highest rate of intraoperative and early postoperative complications with the use of various methods of access to the renal collecting system during percutaneous nephrolithotomy for the treatment of kidney stones greater than 2 cm.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2017
Last Updated
June 14, 2017
Sponsor
Dr Carlos Hernández
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1. Study Identification

Unique Protocol Identification Number
NCT03189264
Brief Title
Percutaneous Nephrolithotomy for Treatment of Kidney Stones Greater Than 2 cm
Official Title
Percutaneous Nephrolithotomy With Coaxial Dilatation vs Pneumatic Balloon for Treatment of Kidney Stones Greater Than 2 cm
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Anticipated)
Study Completion Date
September 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Carlos Hernández

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure considered as the treatment of choice for the management of large-scale and fully-formed kidney stones.This procedure has a 5% risk of complications including bleeding, the lesion of the collecting system, the risk of urinary infection and bacteremia. New surgical tools such as dilatation of the nephrostomy tract with mechanical dilatation contribute to the reduction of these risks, together with an improvement in the operative times and a lower rate of complications. At present there are multiple scales measuring the lithiasic morphology (Guy, the STONE nephrolitometry score system and the nomogram of the Office of Clinical Investigation of the Endourology Society - CROES) which allow to evaluate the degree of complexity of the stone, the possibility of residual stones and the risk of complications. These tools allow us to do a better analysis of the risk factors of the patient who will be taken to this type of endoscopic procedure in order to decrease morbidity and complication rates. Hypothesis: The use of pneumatic dilators during percutaneous nephrolithotomy reduces the rates of intraoperative and postoperative complications, which would have an impact on hospitalization times and surgical success for the management of renal stone.
Detailed Description
Nephrolithiasis is a major worldwide source of morbidity, constituting a common urological disease affecting 10-15% of the world population, with a subsequent clinical relapse rate of approximately 50%. Recent technological and surgical advances have reduced the need for open surgery with less invasive procedures, such as percutaneous nephrolithotomy (PCNL), extracorporeal shock wave lithotripsy (SWL) and retrograde ureteroscopy. The selection of the surgical procedure generally depends on the size, composition, location of the renal stone, the existence of obstruction and anatomical variations of the urinary system. Today, PCNL is the established procedure for stone greater than 2 cm; The procedure usually involves three main stages: it begins with the insertion of a ureteral catheter to perform a retrograde study with contrast medium where the anatomy of the kidney is evaluated, then the puncture is performed by inserting a surgical needle on the skin to the specific location of the stone, with subsequent dilatation of the tract to the collecting system, and once this access has been made it is proceeded to carry out the fragmentation and extraction of the stone through various types of instruments. The success and results of the treatment of surgery are very well known and highly dependent on precision in the puncture stage (the stones must be achieved with a precise and direct path), make this step is the most challenge for surgeons. The ideal access is one that allows complete removal of the stones while minimizing intraoperative bleeding. Needle punctures and their complications, such as kidney injuries and adjacent organs, eventually impair the overall surgical success and outcome of the patient. Although PCNL is considered minimally invasive surgery (MIS) with many associated benefits, such as the production of small incisions in the patient, reducing hospitalization time and postoperative recovery, some complications still occur frequently. The dilation of the nephrostomy tract is the second step in which there are more complications, since it depends on an optimal puncture of the collecting system and a precise manual control to avoid damages of the collecting system or to increase the risks of bleeding. Restricted vision, difficulty in handling the Instrumental, restrictive mobility within the kidney, skill levels of hand-eye coordination of the surgeon, deviation of the needle, moving anatomical objective, are a constant challenge for the surgeon. Several technological advances have been proposed to improve the effectiveness of this procedure. In regard to puncture and dilatation, relevant contributions have been provided by the improvement in medical imaging techniques, as well as the fusion of multiple imaging procedures. Main goal To determine the highest rate of intraoperative and early postoperative complications (bleeding, pain) with the use of the various methods of access to the renal collecting system during percutaneous nephrolithotomy for the treatment of kidney stones greater than 2 cm than 2 cm between April 2017 and January 2018.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone
Keywords
Percutaneous Nephrolithotomy, Postoperative Complications, Renal Stone, Surgical Success, Surgical Complications, Pneumatic Dilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous nephrolithotomy with Coaxial Dilatation
Arm Type
Active Comparator
Arm Description
Percutaneous nephrolithotomy with Coaxial Dilatation for treatment of kidney stones greater than 2 cm.
Arm Title
Percutaneous nephrolithotomy with Pneumatic Balloon
Arm Type
Placebo Comparator
Arm Description
Percutaneous nephrolithotomy with Pneumatic Balloon for treatment of kidney stones greater than 2 cm.
Intervention Type
Procedure
Intervention Name(s)
percutaneous nephrolithotomy for kidney stones
Other Intervention Name(s)
Percutaneous nephrolithotomy with Coaxial Dilatation, Percutaneous nephrolithotomy with Pneumatic Balloon
Intervention Description
Use of various methods of access to the renal collecting system (pneumatic balloon dilatation vs. traditional technique with coaxial dilators) during percutaneous nephrolithotomy for treatment of kidney stones greater than 2 cm.
Primary Outcome Measure Information:
Title
Rate of intraoperative and postoperative complications that occur with the use of pneumatic dilation and with traditional coaxial dilatation.
Description
To determine the highest rate of intraoperative and early postoperative complications with the use of various methods of access to the renal collecting system during percutaneous nephrolithotomy for the treatment of kidney stones greater than 2 cm.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient over 18 years old Non-staghorn kidney stones greater than 2 cm Exclusion Criteria: Coagulopathies Solitary Functioning Kidney Pyonephrosis Pregnancy Urinary tract infection Cardiopulmonary Restrictions Limiting Prone Position BMI greater than 35 More of 2 puncture of the excretory tract STONE score equal or greater than 12
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos E Hernandez, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO LOS COMUNEROS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andres Gutierrez, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO LOS COMUNEROS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose G Ramos, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO LOS COMUNEROS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Diana M Chaparro, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO LOS COMUNEROS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eduardo Ardila, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO LOS COMUNEROS
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Los Comuneros
City
Bucaramanga
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21388242
Citation
Lopes T, Sangam K, Alken P, Barroilhet BS, Saussine C, Shi L, de la Rosette J; Clinical Research Office of The Endourological Society Percutaneous Nephrolithotomy Study Group. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: tract dilation comparisons in 5537 patients. J Endourol. 2011 May;25(5):755-62. doi: 10.1089/end.2010.0488. Epub 2011 Mar 9.
Results Reference
background
PubMed Identifier
13233046
Citation
GOODWIN WE, CASEY WC, WOOLF W. Percutaneous trocar (needle) nephrostomy in hydronephrosis. J Am Med Assoc. 1955 Mar 12;157(11):891-4. doi: 10.1001/jama.1955.02950280015005. No abstract available.
Results Reference
result
PubMed Identifier
1006190
Citation
Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
Results Reference
result
PubMed Identifier
25221917
Citation
Beiko D, Elkoushy MA, Kokorovic A, Roberts G, Robb S, Andonian S. Ambulatory percutaneous nephrolithotomy: what is the rate of readmission? J Endourol. 2015 Apr;29(4):410-4. doi: 10.1089/end.2014.0584. Epub 2014 Oct 23.
Results Reference
result
PubMed Identifier
26225169
Citation
Tailly T, Razvi H. The S.T.O.N.E. nephrolithometry scoring system: How valid is it? Can Urol Assoc J. 2015 May-Jun;9(5-6):196. doi: 10.5489/cuaj.3020. No abstract available.
Results Reference
result
PubMed Identifier
21333334
Citation
Thomas K, Smith NC, Hegarty N, Glass JM. The Guy's stone score--grading the complexity of percutaneous nephrolithotomy procedures. Urology. 2011 Aug;78(2):277-81. doi: 10.1016/j.urology.2010.12.026. Epub 2011 Feb 17.
Results Reference
result
PubMed Identifier
25530366
Citation
Akhavein A, Henriksen C, Syed J, Bird VG. Prediction of single procedure success rate using S.T.O.N.E. nephrolithometry surgical classification system with strict criteria for surgical outcome. Urology. 2015 Jan;85(1):69-73. doi: 10.1016/j.urology.2014.09.010.
Results Reference
result
PubMed Identifier
23540858
Citation
Okhunov Z, Friedlander JI, George AK, Duty BD, Moreira DM, Srinivasan AK, Hillelsohn J, Smith AD, Okeke Z. S.T.O.N.E. nephrolithometry: novel surgical classification system for kidney calculi. Urology. 2013 Jun;81(6):1154-9. doi: 10.1016/j.urology.2012.10.083. Epub 2013 Mar 26.
Results Reference
result
PubMed Identifier
21130245
Citation
Shahrour W, Andonian S. Ambulatory percutaneous nephrolithotomy: initial series. Urology. 2010 Dec;76(6):1288-92. doi: 10.1016/j.urology.2010.08.001.
Results Reference
result
PubMed Identifier
20694090
Citation
Beiko D, Lee L. Outpatient tubeless percutaneous nephrolithotomy: the initial case series. Can Urol Assoc J. 2010 Aug;4(4):E86-90. doi: 10.5489/cuaj.886.
Results Reference
result

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Percutaneous Nephrolithotomy for Treatment of Kidney Stones Greater Than 2 cm

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