Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
NCT ID: NCT03567421
Last Updated: 2021-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2348 participants
OBSERVATIONAL
2018-06-07
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones
NCT05738304
Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
NCT03855787
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
NCT04145063
The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
NCT03130907
Ureteral Stent Versus Percutaneous Nephrostomy in Acutely Obstructed Infected Kidney
NCT03498794
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semi-rigid and/or flexible ureteroscopy
Exclusion Criteria
18 Years
99 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Société Internationale d'Urologie
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joyce Baard, MD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mihir Desai, MD
Role: STUDY_CHAIR
University of Southern California, United States
Jean de la Rosette, MD
Role: STUDY_DIRECTOR
Istanbul Medipol University, Istanbul, Turkey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Minnesota
Minneapolis, Minnesota, United States
Guangdong Second Provincial General Hospital, The Third Clinical Medical College of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University and Guangdong Key Laboratory of Urology
Guangzhou, , China
Ningbo First Hospital, The Affiliated Hospital of Ningbo University
Ningbo, , China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, , China
Shanghai Changhai Hospital, Second Military Medical University
Shanghai, , China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Aretaieion Hospital
Athens, , Greece
Sismanoglio General Hospital
Athens, , Greece
University of Crete, Department of Urology
Heraklion, , Greece
Department of Urology, University Hospital of Larissa
Larissa, , Greece
1st Department of Urology, Aristotle University
Thessaloniki, , Greece
Jawahar Lal Nehru (JLN) Medical College
Ajmer, Rajasthan, India
Kulkarni Reconstructive Urology Center
Pune, , India
Department of Urology, Hasan Sadikin Hospital/Padjadjaran University
Bandung, , Indonesia
Department of Urology, Sanglah Hospital/Udayana University
Denpasar, , Indonesia
Department of Urology, Cipto Mangunkusumo Hospital/University of Indonesia
Jakarta, , Indonesia
Department of Urology, Saiful Anwar Hospital/Brawijaya University
Malang, , Indonesia
Department of Urology, Dr. Soetomo Hospital/Airlangga University
Surabaya, , Indonesia
Department of Urology, Sardjito Hospital/Gadjah Mada University
Yogyakarta, , Indonesia
Shahid Beheshti Hospital, Hamadan University of Medical Sciences
Hamadan, , Iran
University of Basra, College of Medicine, Urology Department
Basra, , Iraq
Pandya Memorial Hospital
Mombasa, , Kenya
Selayang Hospital
Batu Caves, , Malaysia
Serdang Hospital
Kajang, , Malaysia
Kuala Lumpur Hospital
Kuala Lumpur, , Malaysia
University of Malaya
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Department of Urology, St. John Clinical Hospital of Emergency
Bucharest, , Romania
International Medical Center
Jeddah, , Saudi Arabia
King Abdulaziz University
Jeddah, , Saudi Arabia
Prince Sultan Military Medical City
Riyadh, , Saudi Arabia
Sefako Makgatho Health Sciences University
Ga-Rankuwa, , South Africa
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Division of Urology, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung
Kaohsiung City, , Taiwan
Department of Urology, Cardinal Tien Hospital
New Taipei City, , Taiwan
Department of Urology, En Chu Kong Hospital
New Taipei City, , Taiwan
Department of Urology, National Taiwan University Hospital
Taipei, , Taiwan
Department of Urology, Cukurova University, Adana
Adana, , Turkey (Türkiye)
Baskent University, Faculty of Medicine, Department of Urology
Ankara, , Turkey (Türkiye)
Department of Urology, Gazi University
Ankara, , Turkey (Türkiye)
Department of Urology, Hacettepe University
Ankara, , Turkey (Türkiye)
Cerrahpasa School of Medicine Istanbul University
Istanbul, , Turkey (Türkiye)
Department of Urology, University of Health Sciences, Bağcılar Hospital
Istanbul, , Turkey (Türkiye)
Istanbul Medipol University, Department of Urology
Istanbul, , Turkey (Türkiye)
Department of Urology, 9 Eylul University
Izmir, , Turkey (Türkiye)
Konya Meram Education & Research Hospital
Konya, , Turkey (Türkiye)
Necmettin Erbakan University, Meram Medical School
Konya, , Turkey (Türkiye)
Selcuk University Selcuklu Medical School
Konya, , Turkey (Türkiye)
Department of Urology, Bulent Ecevit University
Zonguldak, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Türk C, Knoll T, Petrik A, et al. EAU Guidelines on Urolithiasis 2016. Available at: https://uroweb.org/wp-content/uploads/EAU-Guidelines-Urolithiasis-2016-1.pdf
Legemate JD, Wijnstok NJ, Matsuda T, Strijbos W, Erdogru T, Roth B, Kinoshita H, Palacios-Ramos J, Scarpa RM, de la Rosette JJ. Characteristics and outcomes of ureteroscopic treatment in 2650 patients with impacted ureteral stones. World J Urol. 2017 Oct;35(10):1497-1506. doi: 10.1007/s00345-017-2028-2. Epub 2017 Mar 20.
ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R2). Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. Accessed March 25, 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
uCARE 2018-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.