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

November 4, 2019 updated by: Ahmed Shoma, Mansoura University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Aldakahlia
      • Mansoura, Aldakahlia, Egypt, 35516
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hemoglobin reduction difference between groups
Time Frame: 8 months
measured in gram/liter
8 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP-LP PCNL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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