Clinical trial NCT03567421: Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
Official title: Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stone;Renal
Stone, Kidney
Stone Ureter
Keywords: stone disease
ureteral stent
stenting
ureteroscopy treatment
stent placement
postoperative ureteral stenting
Société Internationale d'Urologie
uCARE
Lead sponsor: Société Internationale d'Urologie
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 2348
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \>18 years old with a ureter or renal stone that are planned for ureteroscopic treatment are eligible for this registry.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients requiring secondary interventions [N]
timeFrame: 6 months
measure: Number of patients requiring pain medication at discharge [N]
timeFrame: 6 months
measure: Duration of the actual internal drain indwelling time [days]
timeFrame: 6 months
measure: Duration of the internal drain indwelling time as indicated by the surgeon [days]
timeFrame: 6 months
measure: % of patients who required anaesthesia for stent removal [Yes/No]
timeFrame: 6 months
measure: Incidence of use of flexible instruments for stent removal following ureteroscopy.
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital, The Third Clinical Medical College of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University and Guangdong Key Laboratory of Urology
city: Ningbo
country: China
facility: Ningbo First Hospital, The Affiliated Hospital of Ningbo University
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Shanghai Changhai Hospital, Second Military Medical University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Athens
country: Greece
facility: Aretaieion Hospital
city: Athens
country: Greece
facility: Sismanoglio General Hospital
city: Heraklion
country: Greece
facility: University of Crete, Department of Urology
city: Larissa
country: Greece
facility: Department of Urology, University Hospital of Larissa
city: Thessaloníki
country: Greece
facility: 1st Department of Urology, Aristotle University
city: Ajmer
country: India
facility: Jawahar Lal Nehru (JLN) Medical College
state: Rajasthan
city: Pune
country: India
facility: Kulkarni Reconstructive Urology Center
city: Bandung
country: Indonesia
facility: Department of Urology, Hasan Sadikin Hospital/Padjadjaran University
city: Denpasar
country: Indonesia
facility: Department of Urology, Sanglah Hospital/Udayana University
city: Jakarta
country: Indonesia
facility: Department of Urology, Cipto Mangunkusumo Hospital/University of Indonesia
city: Malang
country: Indonesia
facility: Department of Urology, Saiful Anwar Hospital/Brawijaya University
city: Surabaya
country: Indonesia
facility: Department of Urology, Dr. Soetomo Hospital/Airlangga University
city: Yogyakarta
country: Indonesia
facility: Department of Urology, Sardjito Hospital/Gadjah Mada University
city: Hamadan
country: Iran, Islamic Republic of
facility: Shahid Beheshti Hospital, Hamadan University of Medical Sciences
city: Basra
country: Iraq
facility: University of Basra, College of Medicine, Urology Department
city: Mombasa
country: Kenya
facility: Pandya Memorial Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Batu Caves
country: Malaysia
facility: Selayang Hospital
city: Kajang
country: Malaysia
facility: Serdang Hospital
city: Kuala Lumpur
country: Malaysia
facility: Kuala Lumpur Hospital
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Bucharest
country: Romania
facility: Department of Urology, St. John Clinical Hospital of Emergency
city: Jeddah
country: Saudi Arabia
facility: International Medical Center
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Military Medical City
city: Ga-Rankuwa
country: South Africa
facility: Sefako Makgatho Health Sciences University
city: Kaohsiung
country: Taiwan
facility: Division of Urology, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung
city: New Taipei City
country: Taiwan
facility: Department of Urology, Cardinal Tien Hospital
city: New Taipei City
country: Taiwan
facility: Department of Urology, En Chu Kong Hospital
city: Taipei
country: Taiwan
facility: Department of Urology, National Taiwan University Hospital
city: Adana
country: Turkey
facility: Department of Urology, Cukurova University, Adana
city: Ankara
country: Turkey
facility: Baskent University, Faculty of Medicine, Department of Urology
city: Ankara
country: Turkey
facility: Department of Urology, Gazi University
city: Ankara
country: Turkey
facility: Department of Urology, Hacettepe University
city: Istanbul
country: Turkey
facility: Cerrahpasa School of Medicine Istanbul University
city: Istanbul
country: Turkey
facility: Department of Urology, University of Health Sciences, Bağcılar Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, Department of Urology
city: İzmir
country: Turkey
facility: Department of Urology, 9 Eylul University
city: Konya
country: Turkey
facility: Konya Meram Education & Research Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Meram Medical School
city: Konya
country: Turkey
facility: Selcuk University Selcuklu Medical School
city: Zonguldak
country: Turkey
facility: Department of Urology, Bulent Ecevit University
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Joyce Baard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California, United States
name: Mihir Desai, MD
role: STUDY_CHAIR
affiliation: Istanbul Medipol University, Istanbul, Turkey
name: Jean de la Rosette, MD
role: STUDY_DIRECTOR
References:
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
citation: 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.
citation: 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.