Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial

NCT04643145 | Unknown

• 1 other identifier: AE 201121
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Flexible ureterorenoscopy (FURS) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (ESWL) and in combination with percutanous nephrolithotomy (PCNL) for stones larger than 20 mm. At the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. It helps prevent obstructive symptoms and the development of strictures. Drainage is done either by a ureteral catheter or by a double J stent. In the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined. The objective of this study will be to assess whether the type of postoperative drainage after URS for kidney stones can influence the perioperative outcomes and health-related quality of life.

Conditions

Stones, Kidney

Keywords

Kidney stones; Flexible ureteroscopy; Quality of life; drainage

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  presence of residual fragments on non contrast computed tomography

  12 weeks after the procedure

Secondary Outcomes (2)

• perioperative complications

  First 3 days postoperative

• Postoperative pain by visual analogue scale

  first 24 hours postoperatively

Study Arms (2)

Ureteral catheter

ACTIVE COMPARATOR

This group will receive ureteral catheter for 2 days after the procedure

Procedure: Flexible ureteroscopy for renal calculi less than 20 mm

Indwelling double J stent

ACTIVE COMPARATOR

This group will receive indwelling double J stent for 2-4 weeks after the procedure

Procedure: Flexible ureteroscopy for renal calculi less than 20 mm

Interventions

Flexible ureteroscopy for renal calculi less than 20 mm PROCEDURE

Patients with renal calculi less than 20 mm will be managed by flexible ureteroscopy. at the end of the procedure, they will be randomized to receive either temporary ureteral catheter for 2 days or indweeling double J stent for 2-4 weeks

Indwelling double J stent; Ureteral catheter

Eligibility Criteria

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

You may qualify if:

• Adult patients (aged \>18 years) 2- Undergo unilateral uncomplicated retrograde intrarenal surgery (RIRS) using flexible ureterorenoscopy.

You may not qualify if:

• Residual ureteral or renal stones after the procedure as documented by the surgeon
• Patients who will need auxiliary procedures (ESWL , re-FURS or PCNL)
• Preoperative febrile UTI
• pregnancy or breastfeeding
• Bilateral ureteroscopic surgery
• Single kidney
• Chronic kidney disease
• Cardiovascular or cerebrovascular disease
• Hepatic dysfunction
• Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Amr A Elsawy

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: November 24, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

EG (1)