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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT04643145

Collaborator

(none)

130

Enrollment

Location

Arms

33.5

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stones, Kidney	Procedure: Flexible ureteroscopy for renal calculi less than 20 mm	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ureteral catheter This group will receive ureteral catheter for 2 days after the procedure	Procedure: Flexible ureteroscopy for renal calculi less than 20 mm 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
Active Comparator: Indwelling double J stent 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 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

Arm

Intervention/Treatment

Active Comparator: Ureteral catheter

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

Procedure: Flexible ureteroscopy for renal calculi less than 20 mm

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

Active Comparator: Indwelling double J stent

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

Outcome Measures

Primary Outcome Measures

Stone free rate [12 weeks after the procedure]
presence of residual fragments on non contrast computed tomography

Secondary Outcome Measures

perioperative complications [First 3 days postoperative]
perioperative complications after the procedure
Postoperative pain by visual analogue scale [first 24 hours postoperatively]
Visual analogue scale will be assessed postoperative

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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