Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes

Stone, Kidney Clinical Trial

Official title:

Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567421
• Other study ID #: uCARE 2018-001
• Status: Completed
• Start date: June 7, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2021
• Source: Société Internationale d'Urologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2348
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Stone Ureter
• Stone, Kidney
• Stone;Renal

Locations

Country	Name	City	State
China	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
Greece	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	Thessaloníki
India	Jawahar Lal Nehru (JLN) Medical College	Ajmer	Rajasthan
India	Kulkarni Reconstructive Urology Center	Pune
Indonesia	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
Iran, Islamic Republic of	Shahid Beheshti Hospital, Hamadan University of Medical Sciences	Hamadan
Iraq	University of Basra, College of Medicine, Urology Department	Basra
Kenya	Pandya Memorial Hospital	Mombasa
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Malaysia	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
Romania	Department of Urology, St. John Clinical Hospital of Emergency	Bucharest
Saudi Arabia	International Medical Center	Jeddah
Saudi Arabia	King Abdulaziz University	Jeddah
Saudi Arabia	Prince Sultan Military Medical City	Riyadh
South Africa	Sefako Makgatho Health Sciences University	Ga-Rankuwa
Taiwan	Division of Urology, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung	Kaohsiung
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
Turkey	Department of Urology, Cukurova University, Adana	Adana
Turkey	Baskent University, Faculty of Medicine, Department of Urology	Ankara
Turkey	Department of Urology, Gazi University	Ankara
Turkey	Department of Urology, Hacettepe University	Ankara
Turkey	Cerrahpasa School of Medicine Istanbul University	Istanbul
Turkey	Department of Urology, University of Health Sciences, Bagcilar Hospital	Istanbul
Turkey	Istanbul Medipol University, Department of Urology	Istanbul
Turkey	Department of Urology, 9 Eylul University	Izmir
Turkey	Konya Meram Education & Research Hospital	Konya
Turkey	Necmettin Erbakan University, Meram Medical School	Konya
Turkey	Selcuk University Selcuklu Medical School	Konya
Turkey	Department of Urology, Bulent Ecevit University	Zonguldak
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Société Internationale d'Urologie

Countries where clinical trial is conducted

United States,  China,  Greece,  India,  Indonesia,  Iran, Islamic Republic of,  Iraq,  Kenya,  Korea, Republic of,  Malaysia,  Romania,  Saudi Arabia,  South Africa,  Taiwan,  Turkey, 

References & Publications (3)

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.

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy	This number will be reported as a % of the total patients enrolled.	6 months
Secondary	Number of patients requiring secondary interventions [N]	Post-operative secondary interventions include JJ placement, ureter splint placement, nephrostomy tube placement, reURS, clot removal, pharmacological intervention, or other.	6 months
Secondary	Number of patients requiring pain medication at discharge [N]	Pain defined as that requiring additional therapy or pain medication, or prolonged hospital stay due to pain.	6 months
Secondary	Duration of the actual internal drain indwelling time [days]	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)	6 months
Secondary	Duration of the internal drain indwelling time as indicated by the surgeon [days]	Calculated as number of days.	6 months
Secondary	% of patients who required anaesthesia for stent removal [Yes/No]	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.	6 months
Secondary	Incidence of use of flexible instruments for stent removal following ureteroscopy.	As indicated by treating surgeon [Yes/No response].	6 months