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Comparison Between 6Fr Vs 4Fr Double J Stent

Primary Purpose

Renal Stone, Ureter Stone

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Double J Stent 6Fr x 26cms
Double J Stent 4Fr x26cms
Sponsored by
Tribhuvan University, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone

Eligibility Criteria

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

Inclusion Criteria: Age> 18yrs Informed Consent Sterile Urine culture prior to surgery Exclusion Criteria: Bilateral DJ stenting Pregnancy Ureteral Strictures Complicated Surgery: Trauma, Bleeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group 1 : 6Fr

    Group 2: 4Fr

    Arm Description

    Procedure: RIRs/URSL Confirmation of Renal/ Ureteric Stone with CT Urography Preanesthetic Check up and SterileUrine Culture obtained prior to surgery Perioperative Care: Inj. Ceftriaxone 1gm IV stat dose , RIRS/ URSL performed using LASER Holmium lithotripsy 6Fr Double J stent is inserted to maintain the ureteric patency USSQ score obtained on Post operative Day 3, Day 7 and on the day of stone removal (Day 14) USG Abdomen and Pelvis is done on post operative Day 30 to confirm stone clearance.

    Procedure: RIRs/URSL Confirmation of Renal/ Ureteric Stone with CT Urography Preanesthetic Check up and SterileUrine Culture obtained prior to surgery Perioperative Care: Inj. Ceftriaxone 1gm IV stat dose , RIRS/ URSL performed using LASER Holmium lithotripsy 4Fr Double J stent is inserted to maintain the ureteric patency USSQ score obtained on Post operative Day 3, Day 7 and on the day of stone removal (Day 14) USG Abdomen and Pelvis is done on post operative Day 30 to confirm stone clearance.

    Outcomes

    Primary Outcome Measures

    To compare USSQ scores following 6Fr vs 4Fr DJ stenting
    USSQ score will be obtained by requesting the participants to fill the questionnaire. The questionnaire will be filled on post operative Day 3, Day 7 and Day 14.

    Secondary Outcome Measures

    To analyze the demographic pattern of patients undergoing URSL and RIRS in TUTH
    All demographic data are entered prior to surgery.
    To compare the pain score, urinary symptoms, general health, sexual symptoms and work performance following 6Fr and 4Fr DJ Stenting
    USSQ score is the sum of the scores of pan symptoms, urinary symptoms, general health symptoms, work performance symptoms and sexual symptoms. All these components will also be analyzed separately.
    To compare stone clearance following 6Fr and 4Fr DJ stenting
    Stone Clearance will be confirmed by ultrasonography done post operatively on Day 30.

    Full Information

    First Posted
    January 13, 2023
    Last Updated
    February 1, 2023
    Sponsor
    Tribhuvan University, Nepal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05725226
    Brief Title
    Comparison Between 6Fr Vs 4Fr Double J Stent
    Official Title
    Comparison Between Standard Vs Small Sized Double J Stent On Urological Symptoms Following RIRS And URSL: A Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tribhuvan University, Nepal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Double J (DJ) Stenting is a commonly done procedure in endourology to ensure ureteric patency following Urological Interventions. DJ stents are available in various sizes. This study is focused on comparing two different sizes of DJ Stents, one standard sized 6Fr and other small sized 4Fr. DJ stents are uncomfortable to the patients and few studies have indicated that small size of stents are might be less troublesome. Through this study we plan to establish a relation between different symptoms and size of DJ stents. Study will be conducted at Tribhuvan University Teaching Hospital (TUTH),Maharajgunj.All adults with sterile urine culture prior to stenting will be taken into consideration. Informed consent will be taken and two randomized groups of 6Fr and 4Fr will be formed and data entry done in MS Excel and analysis done by SPSS. The study is expected to take duration of 12months. Ureteral Stent Symptom Questionnaire (USSQ) will evaluate the symptoms on third day and seventh day of stent placement and on Day of stent removal. We expect 4Fr stent to be superior to 6Fr for reduction of stent related symptoms.
    Detailed Description
    The concept of the endoscopic access to the renal collecting systems for the diagnosis and treatment of upper urinary tract diseases was firstly introduced by V. Marshall who first described in 1964 the navigation in the renal pelvis with a rudimental flexible fiberscope. Retrograde intrarenal surgery (RIRS) by means of flexible ureterorenoscopes (fURSs) is considered one of the first-line treatment options for the active removal of renal stones. Ureteroscopic Lithotripsy (URSL) with the holmium laser is an effective and safe method for treating ureterolithiasis. After RIRS, one of the technical aspect is the placement of a double-J stent. The underlying rationale of ureteric stent is to allow the urinary flow to bypass internal or external obstructions, which impair its drainage. 'Double-J' refers to the most common type of stent design that was initially introduced by Finney in 1978. The term 'double-J' refers to the 'J' shape of each end of the stent, which is designed to anchor the stent and prevent its displacement. The mean size of normal ureter is 1.8mm with a standard deviation of 0.9 mm. The standard size for double J stents is typically 6 Fr. Few studies have been done comparing standard 6Fr and smaller sized DJ stent. One study published in March 2018 has shown 4Fr stent superior to 5Fr and 6Fr stent. A Randomised Control Trial (RCT) published in July 2018 has shown 4.8 Fr stent superior to 6Fr stent. To assess ureteral stent-related symptoms, Joshi et al. described and validated the Ureteral Stent Related Symptom Questionnaire (USSQ) in 2003. This self-administered questionnaire includes questions in six sections: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. The total score is the sum of all questions. This questionnaire can define and compare stent-related symptoms. DJ stent cause significant side effects. Dysuria, urinary frequency and urgency were reported by 40%, 50% and 55% of the patients, respectively. Flank pain, gross hematuria and fever was reported by 32%, 42% and 15% respectively. Anxiety and sleep disturbance were reported by 24% and 20% respectively, and 45% of patients reported impairment in their quality of life. Decreased libido was reported by 45%, and sexual dysfunction by 42% of men and 86% of women. With few studies showing small sized DJ stent causing less symptoms that standard 6Fr stents; our study aims to ascertain whether the previous studies were in line to change the standard size of DJ stent from 6Fr to smaller size, possibly 4Fr. 6Fr DJ stent is commonly used in our center. This study is aimed to compare standard size of DJ stent with small size in TUTH. All cases of urinary tract stones requiring endourologic intervention will be sampled for study and cases meeting the inclusion criteria will be randomized via simple random sampling and computer generated numbers enclosed in a sealed envelope opened just prior to surgery, into two groups: Group A 6Fr and Group B 4Fr. All cases will receive a single dose of ceftriaxone intraoperatively. RIRS will be done using Ureteral Access Sheath (UAS) 9.5-11.5 Fr. DJ Stent 4Fr or 6Fr will be used and length of DJ Stent will be 26cm. Stent will be removed on the 14th postoperative day. Symptoms will be assessed on day 3, day 7 and on the day of stent removal. Stone Clearance will be assured after 1 month with ultrasonography of abdomen.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants are assigned to study where two groups of treatments, Group 1 (6 Fr) and Group 2 (4Fr), are given so that Group 1 will receive 6Fr Double J stent after endourological stone fragmentation and Group 2 will receive 4Fr Double J stent after endourological stone fragmentation.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 : 6Fr
    Arm Type
    Active Comparator
    Arm Description
    Procedure: RIRs/URSL Confirmation of Renal/ Ureteric Stone with CT Urography Preanesthetic Check up and SterileUrine Culture obtained prior to surgery Perioperative Care: Inj. Ceftriaxone 1gm IV stat dose , RIRS/ URSL performed using LASER Holmium lithotripsy 6Fr Double J stent is inserted to maintain the ureteric patency USSQ score obtained on Post operative Day 3, Day 7 and on the day of stone removal (Day 14) USG Abdomen and Pelvis is done on post operative Day 30 to confirm stone clearance.
    Arm Title
    Group 2: 4Fr
    Arm Type
    Experimental
    Arm Description
    Procedure: RIRs/URSL Confirmation of Renal/ Ureteric Stone with CT Urography Preanesthetic Check up and SterileUrine Culture obtained prior to surgery Perioperative Care: Inj. Ceftriaxone 1gm IV stat dose , RIRS/ URSL performed using LASER Holmium lithotripsy 4Fr Double J stent is inserted to maintain the ureteric patency USSQ score obtained on Post operative Day 3, Day 7 and on the day of stone removal (Day 14) USG Abdomen and Pelvis is done on post operative Day 30 to confirm stone clearance.
    Intervention Type
    Device
    Intervention Name(s)
    Double J Stent 6Fr x 26cms
    Intervention Description
    Surgery will be performed by expert Urologist.
    Intervention Type
    Device
    Intervention Name(s)
    Double J Stent 4Fr x26cms
    Intervention Description
    Surgery will be performed by expert Urologist.
    Primary Outcome Measure Information:
    Title
    To compare USSQ scores following 6Fr vs 4Fr DJ stenting
    Description
    USSQ score will be obtained by requesting the participants to fill the questionnaire. The questionnaire will be filled on post operative Day 3, Day 7 and Day 14.
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    To analyze the demographic pattern of patients undergoing URSL and RIRS in TUTH
    Description
    All demographic data are entered prior to surgery.
    Time Frame
    1day, on the date of admission
    Title
    To compare the pain score, urinary symptoms, general health, sexual symptoms and work performance following 6Fr and 4Fr DJ Stenting
    Description
    USSQ score is the sum of the scores of pan symptoms, urinary symptoms, general health symptoms, work performance symptoms and sexual symptoms. All these components will also be analyzed separately.
    Time Frame
    14 days
    Title
    To compare stone clearance following 6Fr and 4Fr DJ stenting
    Description
    Stone Clearance will be confirmed by ultrasonography done post operatively on Day 30.
    Time Frame
    Post operative day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age> 18yrs Informed Consent Sterile Urine culture prior to surgery Exclusion Criteria: Bilateral DJ stenting Pregnancy Ureteral Strictures Complicated Surgery: Trauma, Bleeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Prajwal Khaiwada, MBBS
    Phone
    9842322985
    Ext
    +977
    Email
    prajwalkhatiwada1000@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bhoj Rj Luitel, MCh Urology
    Phone
    9851222344
    Ext
    +977
    Email
    drbhojraj@'gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pawan Rj Chalise, MCh Urology
    Organizational Affiliation
    Head of Department, Department of Urology and Kidney Transplant Surgery, TUTH
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison Between 6Fr Vs 4Fr Double J Stent

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