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

Not Applicable

• Conditions: Urolithiasis; Percutaneous Nephrolithotomy (PNL); Pain; Nephrolithotomy; Nephrostomy Tube (NT)
• Interventions: Procedure: small-bore nephrostomy tube (SBNT); Procedure: large-bore nephrostomy tube (LBNT)

• Registration Number: NCT04153474
• Lead Sponsor: Mansoura University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-10
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
small-bore nephrostomy tube (SBNT)	small-bore nephrostomy tube (SBNT)	small-bore 14 french nephrostomy tube (SBNT)
large-bore nephrostomy tube (LBNT)	large-bore nephrostomy tube (LBNT)	large-bore 22 french nephrostomy tube (LBNT)

Primary Outcome Measures

Name	Time	Method
Rate of hemoglobin reduction difference between groups	8 months	measured in gram/liter

Secondary Outcome Measures

Name	Time	Method
postoperative pain score	8 months	Assessed by Visual Analogue Scale (VAS) points from 0 to 10
postoperative patient satisfaction	8 months	measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6
overall postoperative complication	8 months	assesed by Clavien-Dindo system

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt