Comparison of results of doppler sonography before and after "laparoscopic artery and lymphatic sparing varicocelectomy" with microsurgical subinguinal varicocelectomy
Comparison of results of doppler sonography before and after "laparoscopic artery and lymphatic sparing varicocelectomy" with microsurgical subinguinal varicocelectomy
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 38 patients.
Settings and conduct
Khuzetan,Emam hospital,clinical trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: Varicocele involvement
Exclusuion criteria: history of coagulation disorders; urinary tract infection
Intervention groups
group A: Patients will be treated with direct access to Subinguinal microsurgery method. group B: Patients will be treated with Laparoscopic method.
Main outcome variables
Body mass index, varicocele severity, varicocele latency, duration of hospitalization, surgical cutting size, artery diameter, vein diameter.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190519043633N1
Registration date:2019-05-28, 1398/03/07
Registration timing:prospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Sepehr Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3734 5759
Email address
hmojk@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-04, 1398/03/14
Expected recruitment end date
2019-11-05, 1398/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of results of doppler sonography before and after "laparoscopic artery and lymphatic sparing varicocelectomy" with microsurgical subinguinal varicocelectomy
Public title
The effect of Doppler ultrasonography on varicocele surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have varicocele symptoms.
Exclusion criteria:
The patient has an active urinary tract infection.
Patients with a history of coagulation disorders.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the 4-block method, individuals will be divided randomly into two equal groups.
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
کمیته اخلاق دانشگاه علوم پزشکی جندی شاپور اهواز ,خوزستان
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-05-10, 1398/02/20
Ethics committee reference number
IR.AJUMS.REC.1398.139
Health conditions studied
1
Description of health condition studied
Varicocele
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Time of Hospitalization
Timepoint
The duration of treatment
Method of measurement
The duration of hospitalization
2
Description
Severity of varicocele
Timepoint
1 and 2 months after surgery
Method of measurement
With clinical examination
Secondary outcomes
1
Description
Hydrocele
Timepoint
2 and 3 weeks after surgery
Method of measurement
With clinical examination
2
Description
Artery diameter
Timepoint
1 and 3 months after surgery
Method of measurement
with doppler sonography
3
Description
Vein diameter
Timepoint
1 and 3 months after surgery
Method of measurement
with doppler sonography
Intervention groups
1
Description
Intervention group: Patients will be treated with subinguinal microsurgical method.
Category
Treatment - Surgery
2
Description
Intervention group: Patients will be treated with laparascopic method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Sepehr esmaeili
Street address
Shahid ahvazian street
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2818
Email
hmojk@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Hayat Mombeini
Street address
Golestan street, Shahr Daneshgahi, Ahvaz Jondishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?