Protocol summary

Summary
The aim of this study was to evaluate patients with non-palpable testes underwent laparoscopy in Besat hospital of Hamedan since June 2009 till June 2010 and to compare these results with open surgery in treating the same condition. During one year, 50 patients with non-palpable testis are evaluated in a quasi-experimental study. inclusion criteria: aging range between 1 to 12 year's old ; patients with bilateral undescended testis without response to medical treatment with HCG. Exclusion criteria: nonacceptance of patient's parents ; palpation of testis after anesthesia and before operation ; patient's death before ending of following time. patients based on the position of testis and vas deferens are assigned to perform a laparoscopic orchiopexy in one or two stages. Patients are underwent further evaluation after surgery. Palpation of testicles in the scrotal sac and their sizes considered as criteria for success in surgery. At the end of the study, surgical site infection, injury to the vas deferens, damage formation to gonadal vessels, scrotal hematoma, and the mortality rate are evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103015945N1
Registration date: 2011-06-20, 1390/03/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-20, 1390/03/30
Registrant information
Name
Majid Rezaii Tavirani
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0081
Email address
tavirani.m@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research for Hamedan University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of laparoscopic orchiopexy on descending testis in patients with non-palpable testis referred to surgery ward of Besat hospital of Hamedan and comparison with open surgery
Public title
treatment of impalpable testis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: aging range between 1 to 12 year's old ; patients with bilateral undescended testis without response to medical treatment with HCG Exclusion criteria: nonacceptance of patient's parents ; palpation of testis after anesthesia and before operation ; patient's death before ending of following time
Age
From 1 year old to 12 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmide avenue, Hamedan
City
Hamedan
Postal code
Approval date
2011-02-07, 1389/11/18
Ethics committee reference number
16/35/9/172853

Health conditions studied

1

Description of health condition studied
impalpable testis
ICD-10 code
Q53.1, Q53
ICD-10 code description
Undescended testicle, unilateral, Undescended testicle, bilateral, Undescended testicle, unspecified

Primary outcomes

1

Description
testis existence in scrotum
Timepoint
6 month
Method of measurement
palpation

Secondary outcomes

1

Description
scrotal hematoma
Timepoint
during 6 month after intervention
Method of measurement
observation and examination

2

Description
Surgical site infection
Timepoint
During 6 month after intervention
Method of measurement
Observation & examination

3

Description
Damage formation to gonadal vessels
Timepoint
During 6 month after intervention
Method of measurement
Observation & examination

4

Description
Injury to the vas deferens
Timepoint
During 6 month after intervention
Method of measurement
Observation & examination

5

Description
Mortality rate
Timepoint
During 6 month after intervention
Method of measurement
Observation & examination

Intervention groups

1

Description
Laparoscopy (minimally invasive procedure without requirement to surgical incision
Category
Treatment - Surgery

2

Description
Open surgery in impalpable testis treatment
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan Besat hospital
Full name of responsible person
Dr.Majid Rezaii Tavirani
Street address
Hamedan Besat hospital, Shahid Motahari avenue, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of research for Hamedan University of Medical Sciences
Full name of responsible person
Dr.Alireza Monsef Esfehani
Street address
Hamedan Besat Hospital, Shahid Motahari avenue, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research for Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Majid Rezaii Tavirani
Position
Post graduate
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid fahmide avenue, Hamedan
City
Hamedan
Postal code
Phone
+98 84 1223 9799
Fax
Email
tavirani.m@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Majid Rezaii Tavirani
Position
Post graduate
Other areas of specialty/work
Street address
Hamedan Besat hospital, Shahid Fahmide avenue, Hamedan
City
Hamedan
Postal code
Phone
+98 84 1223 9799
Fax
Email
tavirani.m@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan Besat hospital
Full name of responsible person
Dr.Majid Rezaii Tavirani
Position
Post graduate
Other areas of specialty/work
Street address
Hamedan Besat hospital, Shahid Motahari avenue, Hamedan
City
Hamedan
Postal code
Phone
+98 84 1223 9799
Fax
Email
tavirani.m@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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