Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03567421 |
|
Recruitment Status :
Completed
First Posted : June 25, 2018
Last Update Posted : April 13, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Background: The exit strategy after ureteroscopy for stone treatment remains a topic for discussion. Current EAU guidelines on urolithiasis state that postoperative stenting is indicated in patients at increased risk of postoperative complications. Stenting is not considered necessary in all other cases, and after uncomplicated procedures.
Objective: To analyse the postoperative ureteral stenting strategy in clinical practice looking at the indication, type of stents used and the duration of stenting after ureteroscopy for stone treatment. Furthermore, the investigators will examine in what setting the stents are being removed postoperatively.
Study design: This study is a prospective, observational, international, multicentre registry study executed by uCARE.
Study population: All patients >18 years with a ureter or renal stone who are planned for ureteroscopic treatment by semi-rigid and/or flexible ureteroscopy are eligible for this study.
| Condition or disease |
|---|
| Stone;Renal Stone, Kidney Stone Ureter |
BACKGROUND AND RATIONALE
The majority of patients with stones receive an indication for its active removal by ureteroscopy. In the last two decades, endourological treatment techniques have evolved with several technological advances through miniaturisation of ureteroscopes, digital improvements, and optical imaging enhancement techniques leading to a better image quality, and the development of different disposables such as single-use digital ureteroscopes. This advancement has led to an increased number of indications for ureteroscopic treatment. Aside from this, there are no specific contraindications for ureteroscopic treatment, apart from general problems such as being unfit for anaesthesia or the presence of urinary tract infections, according to the EAU guidelines.
The indications for active stone removal of ureteral stones include persistent pain or obstruction, renal insufficiency, and in cases when spontaneous passage is less likely. The indications for active removal of renal stones include stone growth, stone formation in patients who are at high risk for stone formation, symptomatic patients, infection, obstruction, stones larger than 15 mm and the comorbidity profile, social situation and preference of the patient.
The procedure can be performed using semi-rigid instruments, mainly for ureter stones, and/or by flexible ureteroscopes, for complete inspection and treatment of the upper tract.
The exit strategy after stone treatment varies depending on patient characteristics and comorbidity, residual stone load, per-operative details and complications, and surgeons' preference. Stent placement is recommended by the EAU guidelines in case of increased postoperative complications; in cases of residual fragments, bleeding, perforation, pregnancy or urinary tract infections; as well as in all doubtful cases to avoid stressful emergencies.
Postoperative stenting increases postoperative morbidity and urologists should carefully balance the pros and cons of postoperative stenting in each individual case. The ideal stent duration is not known. Ureteral stents are usually removed 1-day postoperatively and most urologists will remove double Js 1-2 weeks postoperatively.
It remains a matter of debate whether to stent a patient postoperatively after a ureteroscopic procedure despite the EAU guidelines statement that routine stenting after an uncomplicated procedure with complete stone removal is not necessary.
STUDY OBJECTIVES
The aim of this registry is to review current clinical practice on postoperative ureteral stenting after ureteroscopy for stone treatment. The investigators will explore the answers to the following questions: What are the indications, predictors and outcomes for stent placement? What types of stents are used and what is the duration for stent placement? Hence, the investigators will assess in what setting the stents are being removed, looking at instrumentation, anaesthetics, and location.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 2348 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes |
| Actual Study Start Date : | June 7, 2018 |
| Actual Primary Completion Date : | August 31, 2019 |
| Actual Study Completion Date : | August 31, 2019 |
- Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy [ Time Frame: 6 months ]This number will be reported as a % of the total patients enrolled.
- Number of patients requiring secondary interventions [N] [ Time Frame: 6 months ]Post-operative secondary interventions include JJ placement, ureter splint placement, nephrostomy tube placement, reURS, clot removal, pharmacological intervention, or other.
- Number of patients requiring pain medication at discharge [N] [ Time Frame: 6 months ]Pain defined as that requiring additional therapy or pain medication, or prolonged hospital stay due to pain.
- Duration of the actual internal drain indwelling time [days] [ Time Frame: 6 months ]This number is auto-calculated based from the date of surgery, and date of stent removal or post-operative visit (if no stent was used)
- Duration of the internal drain indwelling time as indicated by the surgeon [days] [ Time Frame: 6 months ]Calculated as number of days.
- % of patients who required anaesthesia for stent removal [Yes/No] [ Time Frame: 6 months ]This intraoperative information will be provided by surgeon to indicate whether anesthesia was required during stent removal. Data to be reported as % of total patients.
- Incidence of use of flexible instruments for stent removal following ureteroscopy. [ Time Frame: 6 months ]As indicated by treating surgeon [Yes/No response].
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient >18 years old
- Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semi-rigid and/or flexible ureteroscopy
Exclusion Criteria:
- Patient <18 years old
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567421
Show 50 study locations
| Principal Investigator: | Joyce Baard, MD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
| Study Chair: | Mihir Desai, MD | University of Southern California, United States | |
| Study Director: | Jean de la Rosette, MD | Istanbul Medipol University, Istanbul, Turkey |
Publications:
| Responsible Party: | Société Internationale d'Urologie |
| ClinicalTrials.gov Identifier: | NCT03567421 |
| Other Study ID Numbers: |
uCARE 2018-001 |
| First Posted: | June 25, 2018 Key Record Dates |
| Last Update Posted: | April 13, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
stone disease ureteral stent stenting ureteroscopy treatment |
stent placement postoperative ureteral stenting Société Internationale d'Urologie uCARE |
|
Kidney Calculi Nephrolithiasis Calculi Pathological Conditions, Anatomical |
Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi |