Evaluation of the success and complications of emergency treatment of endoscopic ureteral stone compared with delayed treatment
Design
All patients with acute renal colic fulfilled inclusion criteria will be interviewed and will be randomly assigned if they agree to be included in the study. The patient will then receive the appropriate treatment based on the type of allocation group assigned. Random allocation will be used via minimization procedure where the initial allocation treatment (first 40 cases) is based on a table of random number, subsequent allocations (from patient 41 onward) are based on a minimization protocol that has a relatively equal sample size in the two groups
Settings and conduct
This study will be a randomized clinical trial with two parallel groups at hasheminejad hospital.Patient are included in this study of patient with renal type painand urinary stone imaging studies
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients over 15 years of age and under 80 years with ureteral stones greater than 6 mm and with normal creatinine, with renal colic from up to one week prior.
exclusion criteria: renal failure(GFR<30), Fever above 38 °C, single kidney, history of ureteral stenosis, leukocytosis above 20,000, and definitive indications of immediate intervention according to the European guideline (associated with urinary tract infection and obstructive uropathy or aneuria) and aspirin and /or anticoagulant drugs use
Intervention groups
Case Group: Includes patients in the immediate emergency ureteroscopic treatment who undergo ureteroscopy within 24 hours of ED visit.
Control Group: includes patients receiving unsuccessful stone expulsive (plus analgesic) therapy for 3 to 4 weeks who will undergo ureteroscopic treatment then
Main outcome variables
Loss of work days, Severity of pain, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190720044279N1
Registration date:2020-06-09, 1399/03/20
Registration timing:registered_while_recruiting
Last update:2020-06-09, 1399/03/20
Update count:0
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
Pejman Shadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8864 4485
Email address
shadpour.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the success and complications of emergency and elective ureteroscopy for treatment of ureteral stones
Public title
Comparison of the success and complications of emergency and elective ureteroscopy for treatment of ureteral stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with acute renal colic who are over 15 years and under 80 years
ureteral stone larger than 6 mm
normal creatinine
Exclusion criteria:
Kidney failure (GFR less than 30)
Fever above 38 ° C
single kidney
A history of ureteral stricture
Leukocytosis above 20,000 and definitive indications of immediate intervention according to the EAU guideline (associated with urinary tract infection, obstructive uropathy or anuria)
aspirin and/or anti-coagulant drugs use
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
According to balance block randomization table prepared for 300 patient with statistical software, 150 patient will be in case and the rest will be in the control group randomly.If a patient is eligible for inclusion, it will be randomly assigned to the allocation group. The patient will then receive the appropriate treatment based on the allocation group type. However, given that the patient will be described as urgent treatment if placed in the immediate treatment group and excluded if not accepted. Random allocation will be used via minimization procedure where the initial allocation treatment (first 40 cases) is based on a table of random number, subsequent allocations (from patient 41 onward) are based on a minimization protocol that has a relatively equal sample size in the two groups. The data, will be entered in SPSS software and Minim program will be employed for the minimization of the clinical data.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-04-25, 1399/02/06
Ethics committee reference number
IR.IUMS.FMD.REC.1399.053
Health conditions studied
1
Description of health condition studied
Ureteral stone
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
Comparing the quality of life in emergency and elective ureteroscopy for treatment of ureteral stones
Timepoint
3 weeks after emergency visit
Method of measurement
Quality of life EQ_5D scale and Visual analogue Scale
Secondary outcomes
1
Description
Comparing the loss of work days in emergency and elective ureteroscopy for treatment of ureteral stones
Timepoint
3 weeks after emergency visit
Method of measurement
Ask from Patient
Intervention groups
1
Description
Intervention group:Includes patients in the immediate emergency ureteroscopic treatment who undergo ureteroscopy within 24 hours of ED visit.
Category
Treatment - Surgery
2
Description
Control group: includes patients receiving unsuccessful stone expulsive (plus analgesic) therapy for 3 to 4 weeks who will undergo ureteroscopic treatment then