Primary sponsors | Société Internationale d'Urologie |
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Secondary sponsors (if any) | |
Overall study status | Ongoing |
Recruitment status | Closed |
Descriptive Information | |
Study 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 we 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 | Primary Objective: To assess current indications of postoperative ureteral stenting after ureteroscopy for urinary stone treatment. After each procedure, we will assess whether a stent is placed and the surgeon has to clarify for what reason the stenting was performed (e.g. need for secondary surgery, residual stones, per-operative complications, ureteral lesion, ureteral stricture, ureteral oedema, difficult ureteral access, use of UAS, duration of surgery, solitary kidney, surgeon’s preference or others). Secondary Objectives: 1. To assess the type (ureter catheter or JJ) and material of stent used. 2. To assess the duration of indwelling time indicated by the surgeon and the actual indwelling time. 3. To identify current set-up for ureteral stent removal. Are the stents removed at the physician’s office (flexible or rigid cystoscopy), in the operating room (OR) by (flexible or rigid) cystoscopy, or at home by the patient (self-removal by a string attached to the JJ). |
Medical condition | Stone Disease |
Study population | All patients >18 years old with a ureter or renal stone that are planned for ureteroscopic treatment are eligible for this registry. |
Treatment type | N/A |
Primary outcome measures | Primary Outcome Measure: [Time Frame: 12 months] |
Secondary outcome measures | Secondary Outcome Measures:
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Recruitment Information | |
Date of first enrollment | 2018-06-07 |
Study start date | 2018-06-01 |
Estimated study completion date | 2019-06-01 |
Estimated primary completion date | 2019-06-30 |
Eligibility | Study population: All patients >18 years old with a ureter or renal stone that are planned for ureteroscopic treatment are eligible for this registry. |
Inclusion criteria |
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Exclusion criteria | Patient <18 years old |
Primary Facility Contact | |
Title | Dr. |
First name | Joyce |
Last name | Baard |
Telephone | +31612635264 |
[email protected] | |
Overall Study Officials | |
First name | Joyce |
Last name | Baard |
Degree | MD |
Organizational affiliation | Academic Medical Centre, Amsterdam,The Netherlands |
Official's role | Study Principal Investigator |
Centers/Contacts | |
Mehmet Balasar, Turkey - Leader
Mahmud Zahid Ünlü, Turkey - Leader
Mehmet Kaynar, Turkey - Leader
Yue Cheng, China
Guohua Zeng, China
Athanasios Dellis, Greece
Athanasios Papatsoris, Greece
Stavros Gravas, Greece
Charalampos Mamoulakis, Greece
Anastasios Anastasiadis, Greece
Nur Rasyid, Indonesia
Sanjay Kulkarni, India
Safendra Siregar, Indonesia
Johan Renaldo, Indonesia
Kadek Budi Santosa, Indonesia
Indrawarman Soerohardjo, Indonesia
Taufiq Nur Budaya, Indonesia
Seyed Habibollah Mousavibahar, Iran
Murtadha Almusafer, Iraq
Sundeep Chavda, Kenya
Teng Aik Ong, Malaysia
Rohan Malek, Malaysia
Vijayan Manogran, Malaysia
Guan Chou Teh, Malaysia
Saiful Azli, Malaysia
Petrisor Geavlete, Romania
Raed Azhar, Saudi Arabia
Raed Azhar, Saudi Arabia
Shingai Mutambirwa, South Africa
Sung Yong Cho, South Korea
Yeong-Shiau Pu, Taiwan
Chia-Cheng Yu, Taiwan
Chung-Cheng Wang, Taiwan
Hsu-Che Huang, Taiwan
Atilla Aridogan, Turkey
Cenk Y. Bilen, Turkey
Guven Aslan, Turkey
N. Aydin Mungan, Turkey
Bora Kupeli, Turkey
Selcuk Guven, Turkey
M. Ilteris Tekin, Turkey
Bulent Onal, Turkey
Emrah Yuruk, Turkey
Michael Borofsky, United States
Rohit Ajmera, India
Yinghao Sun, China
Lei Cui, China
Wei Xue, China
Ali Obied, Saudi Arabia
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Publications/Documents | |
Publication status | Completed |
If other, please specify | |
Publication link | https://siuj.org/index.php/siuj/article/view/87/30 |