The aim of present study is to evaluate the results of single scrotal incision orchiopexy and comparing with traditional inguinal orchiopexy method for children with palpable low-lying undescended testis in inguinal canal. In a single center randomized clinical trial study, 60 patients with undescended testis who referred to Children Hospital educational-medical center of Tabriz University of Medical Sciences will allocate in two groups. Inclusion criteria are children with age under 2 years old, unilateral undescended testis, no touch of testes in inguinal canal, and low-lying undescended testis. Exclusion criteria are history of inguinal surgery, history of abdominal surgery, secondary ascending testes, ectopic testes, and ambiguous genitalia. In first group orchiopexy will done with low invasive single scrotal incision technique (n=30) and in second group orchiopexy will done with classic double incision technique (inguinal region & scrotal) (n=30). After surgery patients will followed up for 6 months. Patients will evaluate in term of duration of surgery and wound infection as primary outcome variables and also will evaluate for rate of recurrence, and testicular atrophy as secondary outcome variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041020663N2
Registration date:2016-05-18, 1395/02/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Davoud Badebarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
badebarind@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University Of Medical Sciences.
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of single scrotal incision orchiopexy for children with palpable low-lying undescended testis with traditional inguinal orchiopexy method
Public title
Comparing of single scrotal incision orchiopexy for children with palpable low-lying undescended testis with traditional inguinal orchiopexy method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with age under 2 years old; unilateral undescended testis; no touch of testes in inguinal canal; low-lying. Exclusion criteria: history of inguinal surgery; history of abdominal surgery; secondary ascending testes; ectopic testes; ambiguous genitalia.
Age
To 2 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
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
Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
TBZMED.REC.1394.819
Health conditions studied
1
Description of health condition studied
Low-lying undescended testis
ICD-10 code
N50.9
ICD-10 code description
Disorder of male genital organs, unspecified
Primary outcomes
1
Description
Wound infection
Timepoint
one week after surgery
Method of measurement
Clinical examination
2
Description
Duration of Surgery
Timepoint
After surgery
Method of measurement
Measurement of surgery time
Secondary outcomes
1
Description
Recurrence of undescended testis
Timepoint
six month after surgery
Method of measurement
Clinical examination
2
Description
Testicular atrophy
Timepoint
six month after surgery
Method of measurement
Clinical examination
Intervention groups
1
Description
In Intervention Group: surgery of undescended testis will be done with single scrotal incision technique.
Category
Treatment - Surgery
2
Description
In control group: surgery of undescended testis will be done with classical double incision technique (inguinal region and scrotal).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Davoud Badebarin
Street address
Children Hospital, Sheshgelan street, Tabriz.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University Of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University Of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Farhadi
Position
Resident of Surgery Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
dbadebarin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department Of Surgery, Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Davoud Badebarin
Position
Pediatric Surgery Sub-specialist.
Other areas of specialty/work
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
badebarind@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ebrahim Farhadi
Position
Resident of Surgery Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
Web page address
dbadebarin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)