Collaborative Applied Research

Registry Studies

Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes (ClinicalTrials.gov:NCT03567421, uCARE 2018-001)

Primary sponsorsSociété Internationale d'Urologie
Secondary sponsors (if any)
Overall study statusOngoing
Recruitment statusClosed

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 conditionstone disease
Study populationAll patients >18 years old with a ureter or renal stone that are planned for ureteroscopic treatment are eligible for this registry.
Treatment typeN/A
Primary outcome measures

Primary Outcome Measure:
1.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.

[Time Frame: 12 months]

Secondary outcome measures

Secondary Outcome Measures:

  1. 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. [Time Frame: 12 months]
  2. 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. [Time Frame: 12 months]
  3. 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) [Time Frame: 12 months]
  4. Duration of the internal drain indwelling time as indicated by the surgeon [days]Calculated as number of days. [Time Frame: 12 months]
  5. % 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. [Time Frame: 12 months]
  6. Incidence of use of flexible instruments for stent removal following ureteroscopy. As indicated by treating surgeon [Yes/No response]. [Time Frame: 12 months]

Recruitment Information

Date of first enrollment2018-06-07
Study start date2018-06-01
Estimated study completion date2019-06-01
Estimated primary completion date2019-06-30
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
  1. Patient >18 years old
  2. Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semirigid and/or flexible ureteroscopy
Exclusion criteria

Patient <18 years old

Primary Facility Contact
TitleDr.
First nameJoyce
Last nameBaard
Telephone+31612635264
Email[email protected]
Overall Study Officials
First nameJoyce
Last nameBaard
DegreeMD
Organizational affiliationAcademic Medical Centre, Amsterdam,The Netherlands
Official's roleStudy Principal Investigator

Centers/Contacts

Turkey - Leader
NameMehmet Balasar
Turkey - Leader
NameMahmud Zahid Ünlü
Turkey - Leader
NameMehmet Kaynar
China
NameYue Cheng
China
NameGuohua Zeng
Greece
NameAthanasios Dellis
Greece
NameAthanasios Papatsoris
Greece
NameStavros Gravas
Greece
NameCharalampos Mamoulakis
Greece
NameAnastasios Anastasiadis
Indonesia
NameNur Rasyid
India
NameSanjay Kulkarni
Indonesia
NameSafendra Siregar
Indonesia
NameJohan Renaldo
Indonesia
NameKadek Budi Santosa
Indonesia
NameIndrawarman Soerohardjo
Indonesia
NameTaufiq Nur Budaya
Iran
NameSeyed Habibollah Mousavibahar
Iraq
NameMurtadha Almusafer
Kenya
NameSundeep Chavda
Malaysia
NameTeng Aik Ong
Malaysia
NameRohan Malek
Malaysia
NameVijayan Manogran
Malaysia
NameGuan Chou Teh
Malaysia
NameSaiful Azli
Romania
NamePetrisor Geavlete
Saudi Arabia
NameRaed Azhar
Saudi Arabia
NameRaed Azhar
South Africa
NameShingai Mutambirwa
South Korea
NameSung Yong Cho
Taiwan
NameYeong-Shiau Pu
Taiwan
NameChia-Cheng Yu
Taiwan
NameChung-Cheng Wang
Taiwan
NameHsu-Che Huang
Turkey
NameAtilla Aridogan
Turkey
NameCenk Y. Bilen
Turkey
NameGuven Aslan
Turkey
NameN. Aydin Mungan
Turkey
NameBora Kupeli
Turkey
NameSelcuk Guven
Turkey
NameM. Ilteris Tekin
Turkey
NameBulent Onal
Turkey
NameEmrah Yuruk
United States
NameMichael Borofsky
India
NameRohit Ajmera
China
NameYinghao Sun
China
NameLei Cui
China
NameWei Xue
Saudi Arabia
NameAli Obied

Publications/Documents

Publication statusPending
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