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Conventional PCNL Versus Tubeless PCNL

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03907930
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
13.1
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL

Condition or Disease Intervention/Treatment Phase
  • Procedure: percutaneous nephrolithotripsy
 N/A

Detailed Description

Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications.

Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types.

This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the "tubeless" PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
group of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNLgroup of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNL
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
triple blinded study
Primary Purpose:
Treatment
Official Title:
Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)
Actual Study Start Date :
Mar 28, 2019
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: conventional

this arm will have both nephrostomy tube and ureteric catheter after completing the operation

Procedure: percutaneous nephrolithotripsy
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
Other Names:
  • PCNL

    		•
    Active Comparator: tubeless

    the arm will have only ureteric catheter rafter completing the operation

    Procedure: percutaneous nephrolithotripsy
    removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
    Other Names:
  • PCNL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of days of hospital stay for both groups [15 days]

      comparison between number of days in hospital for both groups

    2. dose of analgesia used to control pain after the procedure [5 days]

      comparison between the dose of analgesia needed for both groups in milligram

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure
    Exclusion Criteria:

    1 - Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation.

    1. Complex or staghorn stones requiring staged procedure.
    Intra operative criteria:
    1. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuit University Hospitals Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: atef abd aziz, professor, assuit university hospital urology departement egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Ahmed Alsayed Ahmed Zowita, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03907930
    Other Study ID Numbers:
    • tubeless PCNL
    First Posted:
    Apr 9, 2019
    Last Update Posted:
    Apr 9, 2019
    Last Verified:
    Apr 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 9, 2019