Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones

Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones

Sponsors

Lead sponsor: Isfahan University of Medical Sciences

Collaborator: Shahid Beheshti University of Medical Sciences

Source Isfahan University of Medical Sciences
Brief Summary

The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones

Detailed Description

While there are several retrospective studies evaluating the efficacy of different lithotripter in percutaneous nephrolithotomy, there are few prospective studies in this regard. This study was designed to compare the efficacy and safety of Ultrasonic versus pneumatic percutaneous nephrolithotomy in treatment of large kidney stones.

Overall Status Completed
Start Date December 2014
Completion Date April 2016
Primary Completion Date April 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
stone free rate 3 months after surgery
Secondary Outcome
Measure Time Frame
hemoglobin loss 2 days after surgery
Enrollment 180
Condition
Intervention

Intervention type: Procedure

Intervention name: Pneumatic percutaneous nephrolithotomy

Description: Pneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone

Arm group label: pneumatic percutaneous nephrolithotomy

Intervention type: Procedure

Intervention name: Ultra-sonic percutaneous nephrolithotomy

Description: Ultra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone

Arm group label: Ultra-sonic percutaneous nephrolithotomy

Eligibility

Criteria:

Inclusion Criteria:

- patients with >2cm kidney stone

Exclusion Criteria:

- Pregnant women

- patients with coagulopathies

- patients with scattered stones who needed several accesses

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Nasser Simforoosh, Prof Study Chair Shahid Beheshty University of Medical Sciences
Verification Date

April 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Isfahan University of Medical Sciences

Investigator full name: Hamidreza Shemshaki

Investigator title: Dr

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: pneumatic percutaneous nephrolithotomy

Arm group type: Active Comparator

Description: pneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone

Arm group label: Ultra-sonic percutaneous nephrolithotomy

Arm group type: Active Comparator

Description: Ultra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov