Evaluation of the efficacy of one stage laparoscopic abdominal testis orchiopexy in supine position vs novel method of laparoscopic orchiopexy in lateral decubitus position with colon medialization as a randomized clinical trial
Evaluation of the efficacy of one stage laparoscopic abdominal testis orchiopexy in supine position Vs novel method of laparoscopic orchiopexy in lateral decubitus position with colon medialization
Design
A clinical trial with two groups of patients: parallel, therapeutic, simple randomization, single blind (The patients have no information about the surgical procedure and the design). 52 patients referred to Sinai Hospital.
Settings and conduct
This clinical trial will be performed on 52 patients at Sina Hospital. single blind (The patients have no information about the surgical procedure and the design).Patients are divided into two groups of surgery and the quality of treatment results is evaluated. After completing the written consent, they will be placed in one of two groups of (one stage laparoscopic abdominal testis orchiopexy in supine position) or (novel method of laparoscopic orchiopexy in lateral decubitus position with colon medialization).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Untouchable testicles, Which is available in laparoscopy and requires archiopexy. Consent to participate in the study. peeping testis,The testicles are pressed only on the abdomen and in the upper part of the inguinal canal
Exclusion criteria: Patients with palpable testicles in the middle of the canal, and scrotum.blind end vessel and vanished testi.Patients over 15 years old.redo patients.Patients splenic fusion or other rare types of abnormalities associated with testicular prolapse (such as Persistent Müllerian Duct Syndrome).Differences in sex development.
Intervention groups
Group1: one stage laparoscopic abdominal testis orchiopexy in supine position.
group2: novel method of laparoscopic orchiopexy in lateral decubitus position with colon medialization.
Main outcome variables
The rate of testicular descent - The rate of complete atrophy at the time of follow-up
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200905048625N2
Registration date:2022-05-09, 1401/02/19
Registration timing:prospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
seyed reza hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
srhoseini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of one stage laparoscopic abdominal testis orchiopexy in supine position vs novel method of laparoscopic orchiopexy in lateral decubitus position with colon medialization as a randomized clinical trial
Public title
One stage laparoscopic abdominal testis orchiopexy in supine position Vs novel method of laparoscopic orchiopexy in lateral decubitus position with colon medialization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Untouchable testicles, Which is available in laparoscopy and requires archiopexy.
Consent to participate in the study
Peeping testis,The testicles are pressed only on the abdomen and in the upper part of the inguinal canal
Exclusion criteria:
Patients with palpable testicles in the middle of the canal, and scrotum
Blind end vessel and vanished testi
Patients over 15 years old
Redo patients
Patients splenic fusion or other rare types of abnormalities associated with testicular prolapse (such as Persistent Müllerian Duct Syndrome)
Differences in sex development
Age
From 12 months old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a single-blind randomized clinical trial.
For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned.
After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team.Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician.The patient is placed in treatment group based on the randomly selected envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who have agreed to participate in the study undergo surgery, then undergo surgery without knowing the existence of two groups of surgeries.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Research in Tehran University of Medical Sciences
Street address
Room 604, Sixth Floor, Tehran medicine University , Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1400.091
Health conditions studied
1
Description of health condition studied
Abdominal testis orchiopexy
ICD-10 code
Q53.11
ICD-10 code description
Abdominal testis, unilateral
Primary outcomes
1
Description
The rate of testicular descent
Timepoint
10 days, 6 weeks and six months after surgery
Method of measurement
Examination of the patient by a physician
Secondary outcomes
1
Description
The rate of complete atrophy at the time of follow-up
Timepoint
10 days, 6 weeks and six months after surgery
Method of measurement
Examination of the patient by a physician
Intervention groups
1
Description
Intervention group: one stage laparoscopic abdominal testis orchiopexy in supine position
Category
Treatment - Surgery
2
Description
Intervention group: novel method of laparoscopic orchiopexy in lateral decubitus position with colon medialization
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Seyed Reza Hosseini
Street address
Urology Research Center, Sina Hospital, Hassan Abad
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
srhoseini@tums.ac.ir
Web page address
http://sinahospital.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
Keshavarz Boulevard, Quds Ave., Central University, Sixth Floor
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 Seyed Reza Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hassan Abad Asqu. Sina Hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8560
Email
srhoseini@tums.ac.ir
Web page address
https://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 hospitals
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 Reza Hosseini 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 the provision of a patient's privacy.