Back to resultsExit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?
Primary Purpose
Urolithiasis, Nephrolithotomy, Percutaneous Nephrolithotomy (PNL)
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
large-bore nephrostomy tube (LBNT)
small-bore nephrostomy tube (SBNT)
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring Percutaneous nephrolithotomy (PNL), Nephrostomy tube (NT), Pain, Patient satisfaction
Eligibility Criteria
Inclusion Criteria:
- Staghorn calculi
- Renal pelvis stones =>2 cm
- Lower pole stones= >1.5 cm
- upper ureteral calculi =>1.5 cm
- SWL-resistant stones
Exclusion Criteria:
- Age <18 years or Pregnancy
- Tubeless PNL
- Need for 3 percutaneous tracts intraoperative
- Morbid obesity (BMI >40)
- Refuse to complete study requirements
- Tumour in the presumptive access tract area or Potential malignant kidney tumour
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
large-bore nephrostomy tube (LBNT)
small-bore nephrostomy tube (SBNT)
Arm Description
large-bore 22 french nephrostomy tube (LBNT)
small-bore 14 french nephrostomy tube (SBNT)
Outcomes
Primary Outcome Measures
Rate of hemoglobin reduction difference between groups
measured in gram/liter
Secondary Outcome Measures
postoperative pain score
Assessed by Visual Analogue Scale (VAS) points from 0 to 10
postoperative patient satisfaction
measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6
overall postoperative complication
assesed by Clavien-Dindo system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04153474
Brief Title
Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?
Official Title
Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America (~75% in USA and Canada) and toward LB NT in South America (~80% in Argentina and Mexico). In Europe the trend is equal (~50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL.
Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Nephrolithotomy, Percutaneous Nephrolithotomy (PNL), Nephrostomy Tube (NT), Pain
Keywords
Percutaneous nephrolithotomy (PNL), Nephrostomy tube (NT), Pain, Patient satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
large-bore nephrostomy tube (LBNT)
Arm Type
Active Comparator
Arm Description
large-bore 22 french nephrostomy tube (LBNT)
Arm Title
small-bore nephrostomy tube (SBNT)
Arm Type
Active Comparator
Arm Description
small-bore 14 french nephrostomy tube (SBNT)
Intervention Type
Procedure
Intervention Name(s)
large-bore nephrostomy tube (LBNT)
Other Intervention Name(s)
LBNT
Intervention Description
large-bore 22 french nephrostomy tube (LBNT)
Intervention Type
Procedure
Intervention Name(s)
small-bore nephrostomy tube (SBNT)
Other Intervention Name(s)
SBNT
Intervention Description
small-bore 14 french nephrostomy tube (SBNT)
Primary Outcome Measure Information:
Title
Rate of hemoglobin reduction difference between groups
Description
measured in gram/liter
Time Frame
8 months
Secondary Outcome Measure Information:
Title
postoperative pain score
Description
Assessed by Visual Analogue Scale (VAS) points from 0 to 10
Time Frame
8 months
Title
postoperative patient satisfaction
Description
measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6
Time Frame
8 months
Title
overall postoperative complication
Description
assesed by Clavien-Dindo system
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Staghorn calculi
Renal pelvis stones =>2 cm
Lower pole stones= >1.5 cm
upper ureteral calculi =>1.5 cm
SWL-resistant stones
Exclusion Criteria:
Age <18 years or Pregnancy
Tubeless PNL
Need for 3 percutaneous tracts intraoperative
Morbid obesity (BMI >40)
Refuse to complete study requirements
Tumour in the presumptive access tract area or Potential malignant kidney tumour
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?
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