Use of feeding tube instead of double J in laparoscopic pyeloplasty surgery
Design
The study is an interventional study in two control groups (12 people) and intervention (12 people), single blind (patient ), phase 3, parallel and therapeutic.
Settings and conduct
This clinical trial will be conducted in Sinai Hospital, Urology Research Center, on 24 patients. Feeding tube treatment group (12 people) Second group: Double G treatment group (12 people)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children between 2 and 15 years old who are candidates for laparoscopic pyeloplasty surgery at Tehran Children's Medical Center
Obtaining the consent of the legal guardian
Exclusion criteria: History of urinary system surgery
History of anatomical disorders of the urinary system, except for stenosis of the junction of the ureter with the pelvis
Poorly controlled diabetes mellitus
Heart problems and sensitivity to anesthetic drugs
Intervention groups
Intervention group: Use of feeding tube in laparoscopic pyeloplasty surgery
Control group:The use of double J in laparoscopic pyeloplasty surgery
Main outcome variables
Cost reduction with simpler technique for stent placement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N25
Registration date:2024-05-10, 1403/02/21
Registration timing:prospective
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2025-08-11, 1404/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A new method of ureteral stenting (feeding tube) during laparoscopic pyeloplasty in children: Crucified StentSystem:a clinical traial
Public title
Ureteral stent during laparoscopic pyeloplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children between 2 and 15 years old who are candidates for laparoscopic pyeloplasty surgery at Tehran Children's Medical Center
Obtaining the consent of the legal guardian
Exclusion criteria:
History of urinary system surgery
History of anatomical disorders of the urinary system, except for stenosis of the junction of the ureter with the pelvis
Poorly controlled diabetes mellitus
Heart problems and sensitivity to anesthetic drugs
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the Permuted balanced block randomization method will be used by creating blocks of four between the two treatment and control groups in a random way. According to the randomization method, the two groups will have a difference of at most two people in the number of allocated people. After the statistics and epidemiology specialist prepares the randomization sequence, the patients will be placed in blocks a and b. Based on the first selection of the patient as a (first group), the next patient will be placed in group b (second group).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be a single blind study and the participants will not know about the treatment process. In the first group: ureteral stent insertion in patients who undergo laparoscopic pyeloplasty surgery. Second group: Double J insertion in ureteral patients who undergo laparoscopic surgery. Pyeloplasty is performed
Cost reduction with simpler technique for stent placement
Timepoint
After the operation and after the feeding tube and double J are removed from the patient's ureter
Method of measurement
Investigating urinary infection and measuring the weight of sediments separated from double G and feeding tube in the medical diagnosis laboratory.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of feeding tube in laparoscopic pyeloplasty surgery
Category
Treatment - Surgery
2
Description
Control group:The use of double J in laparoscopic pyeloplasty surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St., Tehran, Iran .
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth Floor, Central University, Quds Ave., Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information anonymously
When the data will become available and for how long
One year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by providing a patient's privacy.