Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102518224713 Date of Registration: 17/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Towards Optimization of Ureteral Health and Improvement of Outcomes During Semirigid Ureteroscopy: 4.5/6 Fr vs. 6/7.5 Fr Ureteroscopes a randomized trial
Official scientific title Towards Optimization of Ureteral Health and Improvement of Outcomes During Semirigid Ureteroscopy: 4.5/6 Fr vs. 6/7.5 Fr Ureteroscopes a randomized trial
Brief summary describing the background and objectives of the trial To compare 4.5/6 Fr versus 6/7.5 Fr semirigid ureteroscopes in terms of safety and efficacy in adult non-obese patients with middle or lower ureteric stones.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/04/2016
Actual trial start date
Anticipated date of last follow up 01/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 198
Actual target sample size (number of participants) 198
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 4.5 Fr semirigid ureteroscopy and stone disintegration by laser once once All the procedures were performed under spinal anesthesia with the patients placed in the lithotomy position. A 272-µ laser fiber over Sphinx™ 30-Watt laser machine (Lisa Laser, Germany) and 1.9 F Zero tip basket was used. We used Sensor™ guidewire (Boston Scientific, USA) for initial cannulation of the ureter with other glide wires available on the surgery tray. At the beginning of the procedure, the ureteroscope was inserted inside the bladder followed by insertion of a guidewire into the desired ureteric orifice under fluoroscopy guidance. Balloon dilatation (18Fr- 4cm Uromax™, Boston Scientific, USA) was only used when the scope failed passively to advance inside the ureter. A Double-J (JJ) stent was inserted in selected cases at the end of surgery, according to the duration of the procedure or presence of ureteral injury. In case of failure to reach the stones, either due to tight ureter or stone migration, a JJ stent was inserted, and the procedure was repeated 3 weeks later. 99
Experimental Group 6 Ff semirigid ureteroscopy and stone disintegration by laser once once All the procedures were performed under spinal anesthesia with the patients placed in the lithotomy position. A 272-µ laser fiber over Sphinx™ 30-Watt laser machine (Lisa Laser, Germany) and 1.9 F Zero tip basket was used. We used Sensor™ guidewire (Boston Scientific, USA) for initial cannulation of the ureter with other glide wires available on the surgery tray. At the beginning of the procedure, the ureteroscope was inserted inside the bladder followed by insertion of a guidewire into the desired ureteric orifice under fluoroscopy guidance. Balloon dilatation (18Fr- 4cm Uromax™, Boston Scientific, USA) was only used when the scope failed passively to advance inside the ureter. A Double-J (JJ) stent was inserted in selected cases at the end of surgery, according to the duration of the procedure or presence of ureteral injury. In case of failure to reach the stones, either due to tight ureter or stone migration, a JJ stent was inserted, and the procedure was repeated 3 weeks later. 99
Control Group control group none none none 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1st episode of ureteric (middle or lower) radiopaque stones, after the failure of medical expulsive therapy, We excluded patients with multiple or bilateral ureteral stones, coagulation disorders, radiolucent stones, children (age <18years), and previous ureteric intervention including ureteroscopy or ureteric stent insertion. BMI >30 Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2016 Menoufia university hospital
Ethics Committee Address
Street address City Postal code Country
Yassin abdelgafar street Shibin el kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of ureteral mucosal injury, perforation, and hematuria ureteral mucosal injury, perforation, and hematuria
Secondary Outcome stone free rate stone free rate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospital Yassin abdelgahafr street Shibon el kom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Omar Yassin abdelgafar street Shibin El Kom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor none none none Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Omar mohammed.kamal.omar@med.menofia.edu.eg 011201066949454 Yassin abdelgafar street
City Postal code Country Position/Affiliation
Shibin El Kom 32511 Egypt Menoufia University
Role Name Email Phone Street address
Public Enquiries mohamed Omar mohammed.kamal.omar@med.menofia.edu.eg 011201066949454 Yassin abdelgafar street
City Postal code Country Position/Affiliation
Shibin el kom Egypt Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Omar mohammed.kamal.omar@med.menofia.edu.eg 011201066949454 Yassin abdel Gafra St
City Postal code Country Position/Affiliation
Shibin El Kom 32511 Egypt Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Conclusions: The use of a 4.5/6 Fr semi-rigid Ureteroscope for management of middle/ lower third ureteric calculi in non-obese patients were associated with avoidance of ureteral balloon dilatation, significantly fewer JJ stenting, shorter hospital stay, and a higher stone-free rate. Statistical Analysis Plan provided The IRB committee at our university
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 12/02/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/02/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information