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

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04153474
Collaborator
(none)
220
Enrollment
1
Location
2
Arms
9.1
Anticipated Duration (Months)
24.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: large-bore nephrostomy tube (LBNT)
  • Procedure: small-bore nephrostomy tube (SBNT)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial
Actual Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: large-bore nephrostomy tube (LBNT)

large-bore 22 french nephrostomy tube (LBNT)

Procedure: large-bore nephrostomy tube (LBNT)
large-bore 22 french nephrostomy tube (LBNT)
Other Names:
  • LBNT

    		•
    Active Comparator: small-bore nephrostomy tube (SBNT)

    small-bore 14 french nephrostomy tube (SBNT)

    Procedure: small-bore nephrostomy tube (SBNT)
    small-bore 14 french nephrostomy tube (SBNT)
    Other Names:
  • SBNT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of hemoglobin reduction difference between groups [8 months]

      measured in gram/liter

    Secondary Outcome Measures

    1. postoperative pain score [8 months]

      Assessed by Visual Analogue Scale (VAS) points from 0 to 10

    2. postoperative patient satisfaction [8 months]

      measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6

    3. overall postoperative complication [8 months]

      assesed by Clavien-Dindo system

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology and Nephrology Center Mansoura Aldakahlia Egypt 35516

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Shoma, Principal Investigator, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT04153474
    Other Study ID Numbers:
    • SP-LP PCNL
    First Posted:
    Nov 6, 2019
    Last Update Posted:
    Nov 6, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Shoma, Principal Investigator, Mansoura University
    Percutaneous nephrolithotomy (PNL)
    Nephrostomy tube (NT)
    Pain
    Patient satisfaction
    Additional relevant MeSH terms:
    Urolithiasis

    Study Results

    No Results Posted as of Nov 6, 2019