Comparison Between 6Fr Vs 4Fr Double J Stent

NCT05725226 | Completed DMC

• 1 other identifier: PKhatiwada
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Stone; Ureter Stone

Outcome Measures

Primary Outcomes (1)

• To compare Ureteral Stent Symptom Questionnaire (USSQ) scores following 6Fr vs 4Fr Double J stenting

  Ureteral Stent Symptom Questionnaire 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. The maximum possible score is 169 and minimum score is 33. Higher score indicates poor performance of Double J stent.

  14 days

Secondary Outcomes (3)

• To analyze the demographic pattern of patients undergoing URSL and RIRS in TUTH

  1day, on the date of admission

• To compare the pain score, urinary symptoms, general health, sexual symptoms and work performance following 6Fr and 4Fr Double J Stenting

  14 days

• To compare stone clearance following 6Fr and 4Fr Double J stenting

  Post operative day 30

Study Arms (2)

Group 1 : 6Fr

ACTIVE COMPARATOR

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.

Device: Double J Stent 6Fr x 26cms

Group 2: 4Fr

EXPERIMENTAL

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.

Device: Double J Stent 4Fr x26cms

Interventions

Double J Stent 6Fr x 26cms DEVICE

Surgery will be performed by expert Urologist.

Group 1 : 6Fr

Double J Stent 4Fr x26cms DEVICE

Surgery will be performed by expert Urologist.

Group 2: 4Fr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> 18yrs
• Informed Consent
• Sterile Urine culture prior to surgery

You may not qualify if:

• Bilateral DJ stenting
• Pregnancy
• Ureteral Strictures
• Complicated Surgery: Trauma, Bleeding

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead

Study Sites (1)

Tribhuvan University Teaching Hospital (TUTH), Institute of Medicine

Kathmandu, Bagmati, 977, Nepal

Location

MeSH Terms

Conditions

Nephrolithiasis; Ureterolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Ureteral Diseases

Study Officials

• Pawan Rj Chalise, MCh Urology

  Head of Department, Department of Urology and Kidney Transplant Surgery, TUTH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor in General Surgery Department

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 13, 2023
• Study Start: April 7, 2023
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)