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Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Primary Purpose

Kidney Stone

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vacuum assisted sheath
passive suction via conventional sheath
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with planned prone mini-PCNL and a preoperative NCCT Primary stone size: 10-25 mm Pre-existing indwelling nephrostomy tube or ureteral stent permitted Age: ≥ 18 years old Gender: all Ethnicity: all Capable of giving informed consent Capable and willing to fulfill requirements of the study Exclusion Criteria: Anticoagulated or history of coagulopathy Congenital renal anomalies Prior ipsilateral upper urinary tract reconstructive procedures Conversion to open procedure Multiple access tracts Inability to give informed consent or unable to meet requirements of the study for any reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    vacuum-assisted sheath

    passive suction via conventional sheath

    Arm Description

    Outcomes

    Primary Outcome Measures

    Aim 1: Stone free rate
    The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray
    Aim 2: Intraoperative variables
    Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL
    Aim 3: Post-operative Outcomes and Complications
    Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS

    Secondary Outcome Measures

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    August 17, 2023
    Sponsor
    The Cleveland Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05993546
    Brief Title
    Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
    Official Title
    Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Cleveland Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.
    Detailed Description
    In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own. Two procedure types will be investigated: Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone. Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Stone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vacuum-assisted sheath
    Arm Type
    Active Comparator
    Arm Title
    passive suction via conventional sheath
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    vacuum assisted sheath
    Intervention Description
    allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
    Intervention Type
    Device
    Intervention Name(s)
    passive suction via conventional sheath
    Intervention Description
    conventional access sheath for stone retrieval using current technique via passive suction
    Primary Outcome Measure Information:
    Title
    Aim 1: Stone free rate
    Description
    The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray
    Time Frame
    6 weeks
    Title
    Aim 2: Intraoperative variables
    Description
    Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL
    Time Frame
    3-7 days
    Title
    Aim 3: Post-operative Outcomes and Complications
    Description
    Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with planned prone mini-PCNL and a preoperative NCCT Primary stone size: 10-25 mm Pre-existing indwelling nephrostomy tube or ureteral stent permitted Age: ≥ 18 years old Gender: all Ethnicity: all Capable of giving informed consent Capable and willing to fulfill requirements of the study Exclusion Criteria: Anticoagulated or history of coagulopathy Congenital renal anomalies Prior ipsilateral upper urinary tract reconstructive procedures Conversion to open procedure Multiple access tracts Inability to give informed consent or unable to meet requirements of the study for any reason

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

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