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NCT04153474 Clinical Trial

Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?

Pain Clinical Trial

Official title:
Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04153474
Other study ID # SP-LP PCNL
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date February 1, 2020

Study information
Verified date October 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 220
Est. completion date February 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Staghorn calculi

2. Renal pelvis stones =>2 cm

3. Lower pole stones= >1.5 cm

4. upper ureteral calculi =>1.5 cm

5. SWL-resistant stones

Exclusion Criteria:

1. Age <18 years or Pregnancy

2. Tubeless PNL

3. Need for 3 percutaneous tracts intraoperative

4. Morbid obesity (BMI >40)

5. Refuse to complete study requirements

6. Tumour in the presumptive access tract area or Potential malignant kidney tumour

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• large-bore nephrostomy tube (LBNT)
large-bore 22 french nephrostomy tube (LBNT)
• small-bore nephrostomy tube (SBNT)
small-bore 14 french nephrostomy tube (SBNT)

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of hemoglobin reduction difference between groups measured in gram/liter 8 months
Secondary postoperative pain score Assessed by Visual Analogue Scale (VAS) points from 0 to 10 8 months
Secondary postoperative patient satisfaction measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6 8 months
Secondary overall postoperative complication assesed by Clavien-Dindo system 8 months
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