Randomized clinical trial comparing the effect of removing the double-J stent without cystoscopy with attaching it to Foley catheter after kidney transplantation
The ureteric stent can be attached to the Foley catheter in the kidney transplantation to exclude the cystoscopy for its removal. There has been no randomized trial to evaluate the effect of this attachment on the major urologic complications.
Design
A concealed, randomized, non-blinded, clinical trial with a parallel group design of 163 patients, enrolled between March 2016 and June 2017 and followed for nine months. Randomization is done with the concealed envelopes. The treatment methods are not blinded to the surgeon and the patients.
Settings and conduct
The study are carried out in Labbafinejad Medical Center, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients more than 15 years old who are the candidate for renal transplantation in the Labbafinejad Medical Center during the study period; informed consent. Exclusion criteria: patients with a history of neurogenic bladder, BPH, bladder surgery; After revascularization and before ureteroneocystostomy if the surgeon feels that the patient is not suitable for attaching the Foley to the stent (like fear of hemorrhage); Postoperatively if there is an extended urinary leak which necessitates the stent removal after seven days.
Intervention groups
Patients are divided randomly with the concealed envelops to intervention and control groups. the Intervention group: the stent is attached to the Foley catheter and removed together. Control group: stent removal is done by cystoscopy. Seven days after the transplant, the stent is removed in both groups.
Main outcome variables
The primary outcomes are major urologic complications (MUCs), i.e., urinary leak, and ureteric obstruction which needed an intervention for treatment. The secondary outcome is pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100313003547N6
Registration date:2019-04-15, 1398/01/26
Registration timing:retrospective
Last update:2019-04-15, 1398/01/26
Update count:0
Registration date
2019-04-15, 1398/01/26
Registrant information
Name
Mohammad Nadjafi-Semnani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 9551
Email address
nadjafi@hbi.ir
Recruitment status
Recruitment complete
Funding source
Urology- Nephrology Research Center – Shahid Beheshti University of Medical Sciences. Tehran - Iran
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
2016-03-01, 1394/12/11
Actual recruitment end date
2017-06-15, 1396/03/25
Trial completion date
2018-12-25, 1397/10/04
Scientific title
Randomized clinical trial comparing the effect of removing the double-J stent without cystoscopy with attaching it to Foley catheter after kidney transplantation
Public title
Effect of removing the double J stent without cystoscopy after kidney transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age less than 76 years;
Patients with age more than 15 years;
All patients who are candidate for renal transplantation by surgeons in the Labbafinejad hospital.
Exclusion criteria:
Neurogenic bladder
History of surgery in urinary bladder
History of bladder outlet obstruction by Benign Prostatic Hyperplasia (BPH)
After revascularization and before ureteroneocystostomy if the surgeon feels that there is need for stent to be removed later than 7 days
Multiple renal arteries
urinary leak that warrant stent removal later than 7 days.
Age
From 16 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
170
Actual sample size reached:
163
Randomization (investigator's opinion)
N/A
Randomization description
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
Urology Nephrology Research Center- Shahid Beheshti Medical University
Street address
Pasdaran St. - 9th Nostan St.
City
Tehran
Province
Tehran
Postal code
1666663731
Approval date
2017-02-13, 1395/11/25
Ethics committee reference number
IR.SBMU.UNIRC.1395.21
Health conditions studied
1
Description of health condition studied
Kidney Transplantation
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Major Urologic Complications (MUC) including urinary leak and ureteral obstruction
Timepoint
Nine months. After discharge, one a week for a month, then every other week for next tow months and then monthly patients will be seen in the clinic
Method of measurement
Urinary leak is defined clinicaly by urine leak through the surgical drain and is confiremd by measuring urine creatinine and by delayed DTPA radionucleic scan. Ureteral obstruction is defined by rising of serum creatinine and finding of obstruction in ultrasonography scan or ante-grade nephrostography.
Secondary outcomes
1
Description
creatinine level in serum
Timepoint
one month, 6 months and 12 months after kidney transplantation
Method of measurement
laboratory measurments
2
Description
Pain experienced during the stent removal
Timepoint
At the stent removal time during first ten days of transplantation
Method of measurement
Pain is measured by visual analogue scale (VAS)
3
Description
The cost of treatment
Timepoint
Three weeks
Method of measurement
The cost of cystoscopy procedure for stent removal is confirmed by hospital administration.
Intervention groups
1
Description
In the intervention group, the double J stent is removed without flexible cystoscopy by attaching the Foley catheter to a double J stent during the operation.
Category
Treatment - Devices
2
Description
Control group: In the control group, the double J stent is removed with the help of flexible or rigid cystoscopy in the operation room.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad Medical Centre
Full name of responsible person
Mohammad Nadjafi-Semnani
Street address
Ninth Boostan Ave.- Pasdaran St. Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Fax
+98 21 2258 8016
Email
nadjafi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ms Golshani
Street address
Pasdaran St. - Ninth Bostan Ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Fax
+98 21 2258 8016
Email
Simforoosh@iurtc.org.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Labafinejad Medical Center, Shahid Beheshti Medical University
Full name of responsible person
Mohammad Nadjafi-Semnani
Position
Associate Professor of Urology
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Ninth Boostan Ave.- Pasdaran St. Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Fax
+98 21 2258 8016
Email
nadjafi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Labafinejad Medical Center, Shahid Beheshti Medical University
Full name of responsible person
Mohammad Nadjafi-Semnani
Position
Associate Professor of Urology
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Ninth Boostan Ave.- Pasdaran St. Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Fax
+98 21 2258 8016
Email
nadjafi@sbmu.ac.ir
Web page address
http://www.iurtc.org.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Nadjafi-Semnani
Position
Associate professor of urology
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Ninth Boostan Ave.- Pasdaran St. Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Fax
+98 21 2258 8016
Email
nadjafi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD