Are the Stone Density and Location Useful Parameters for Small Kidney Stones?

NCT ID: NCT03503539

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-06-30

Brief Summary

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The investigators aimed to evaluate whether these parameters could be guides for us in the selection of RIRS or Mini-PNL procedures in kidney stones that are smaller than 2 cm.

The patients that have kidney stones smaller than two cm and be planned to undergo surgery were randomized into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while Mini-PCNL group was dilated up to 16.5F and mini-PCNL was performed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of HU value, indicating the stone density, higher or less than 677 and the stone location on stone-free rates.

Detailed Description

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Conditions

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Kidney Calculi Kidney Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mini percutaneous nephrolithotomy

All operations were performed or supervised by the same surgeon. Right after the patients in mini-PNL group were placed a 5F ureteral catheter with general anesthesia, they were had a prone position and the access was performed by choosing the optimal calyx to reach the stone following the contrast agent was given. The guide wire was then placed and the stones were broken with a laser lithotripter using a 12F nephroscope (Modular minimally invasive PCNL system, Karl Storz, Tuttlingen, Germany) following the dilatation using an one step dilator with a 16.5F access sheath. When necessary, stones were removed using the stone removal forceps. Right after a 14-Fr nephrostomy tube was inserted and an antegrade pyelography was taken, the operation was terminated.

Group Type EXPERIMENTAL

Mini percutaneous nephrolithotomy

Intervention Type PROCEDURE

Retrograde intrarenal surgery

Following the general anesthesia performed, a safety guide wire was placed and semirigid ureteroscopy (9.5 / 11.5F) was performed. Stones were fragmented using a 270 micron meter laser fiber with the help of 7.5-F fiber optic flexible ureterorenoscope after the placement of ureteral access sheat (9.5 / 11.5 F). Stone fragmentation was accomplished using a laser energy of 0.5-1.5 J and a rate of 5-15 Hz and adjusting this range according to stone hardness. 4.7F JJ stent was routinely placed at the end of the operation because of worries about possible edema etc. due to access sheath. In this group, access sheath could not be placed in 2 patients due to the small diameter of the ureter, and JJ stent was placed, and 2 weeks later, the procedure was performed as it was in the others.

Group Type ACTIVE_COMPARATOR

Retrograde intrarenal surgery

Intervention Type PROCEDURE

Interventions

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Mini percutaneous nephrolithotomy

Intervention Type PROCEDURE

Retrograde intrarenal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients were evaluated with non-contrast abdominopelvic CT after a detailed anamnesis and physical examination.
* Patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo ESWL, were taken into the study.

Exclusion Criteria

* Patients with anomalous kidneys, skeletal deformities, severe obesity (BMI\> 35) and those underwent ESWL treatment previously for the same stone were excluded from the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Adnan Gucuk

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Demirbas A, Resorlu B, Sunay MM, Karakan T, Karagoz MA, Doluoglu OG. Which Should be Preferred for Moderate-Size Kidney Stones? Ultramini Percutaneous Nephrolithotomy or Retrograde Intrarenal Surgery? J Endourol. 2016 Dec;30(12):1285-1289. doi: 10.1089/end.2016.0370.

Reference Type RESULT
PMID: 27706948 (View on PubMed)

Jacquemet B, Martin L, Pastori J, Bailly V, Guichard G, Bernardini S, Chabannes E, Bittard H, Kleinclauss F. Comparison of the efficacy and morbidity of flexible ureterorenoscopy for lower pole stones compared with other renal locations. J Endourol. 2014 Oct;28(10):1183-7. doi: 10.1089/end.2014.0286. Epub 2014 Sep 12.

Reference Type RESULT
PMID: 24811281 (View on PubMed)

Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.

Reference Type RESULT
PMID: 22840867 (View on PubMed)

Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.

Reference Type RESULT
PMID: 21855968 (View on PubMed)

Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis. Eur Urol. 2016 Mar;69(3):468-74. doi: 10.1016/j.eururo.2015.07.040. Epub 2015 Aug 28.

Reference Type RESULT
PMID: 26318710 (View on PubMed)

Gucuk A, Uyeturk U, Ozturk U, Kemahli E, Yildiz M, Metin A. Does the Hounsfield unit value determined by computed tomography predict the outcome of percutaneous nephrolithotomy? J Endourol. 2012 Jul;26(7):792-6. doi: 10.1089/end.2011.0518. Epub 2012 Feb 10.

Reference Type RESULT
PMID: 22201298 (View on PubMed)

Other Identifiers

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AbantIBU-AG001

Identifier Type: -

Identifier Source: org_study_id

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