Back to resultsThe Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
Primary Purpose
Varicocele; Male Infertile;Varicocelectomy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
open operation
microsurgery
Sponsored by
About this trial
This is an interventional treatment trial for Varicocele; Male Infertile;Varicocelectomy focused on measuring varicocele; male infertile;varicocelectomy
Eligibility Criteria
Inclusion Criteria:
- 1.infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy
Exclusion Criteria:
- 1.varicocele patient with abdominal infection 2.varicocele patient who has massive adhesion of pelvic tissue due to pelvic surgery history 3.mild varicocele 4.varicocele patient has no obvious symptoms if has have born children, suffer from idiopathic azoospermia，or their partner can't bear children
Sites / Locations
- First Affiliated hospital，Sun Yat-Sen University.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
open operation
microsurgery
Arm Description
high ligation of spermatic vein by open operation
high ligation of spermatic vein by microsurgery
Outcomes
Primary Outcome Measures
the quality of semen and the level of sexual hormone
The semen analyses and were sexual hormones determinations conducted before and three and six months after surgery.Then the quality of semen and the level of sexual hormone before and after surgery were compared.
complications
the complications such as recurrence, hydrocele,orchiatrophy and wound infection were assessed one, three and six months postoperation. Color doppler ultrasonography and physical examination are the main methods to assess the complications
Secondary Outcome Measures
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity.
Full Information
NCT ID
NCT01757548
First Posted
December 14, 2012
Last Updated
December 28, 2012
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01757548
Brief Title
The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
Official Title
The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether high ligation of spermatic vein by open operation and microsurgery for patients with are effective in the treatment of varicocele and to determine which surgical option is better.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele; Male Infertile;Varicocelectomy
Keywords
varicocele; male infertile;varicocelectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open operation
Arm Type
Experimental
Arm Description
high ligation of spermatic vein by open operation
Arm Title
microsurgery
Arm Type
Experimental
Arm Description
high ligation of spermatic vein by microsurgery
Intervention Type
Procedure
Intervention Name(s)
open operation
Intervention Description
high ligation of spermatic vein by open operation
Intervention Type
Procedure
Intervention Name(s)
microsurgery
Intervention Description
high ligation of spermatic vein by microsurgery
Primary Outcome Measure Information:
Title
the quality of semen and the level of sexual hormone
Description
The semen analyses and were sexual hormones determinations conducted before and three and six months after surgery.Then the quality of semen and the level of sexual hormone before and after surgery were compared.
Time Frame
before and three and six months after surgery
Title
complications
Description
the complications such as recurrence, hydrocele,orchiatrophy and wound infection were assessed one, three and six months postoperation. Color doppler ultrasonography and physical examination are the main methods to assess the complications
Time Frame
one, three and six months postoperation
Secondary Outcome Measure Information:
Title
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity
Description
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity.
Time Frame
before and one,three and six months after surgery
Other Pre-specified Outcome Measures:
Title
general information
Description
Before surgery, all patients were diagnosed by physical examination and testified by color Doppler ultrasound. And we documented the patients' age, left unilateral or bilateral and the grade of varicocele
Time Frame
before surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy
Exclusion Criteria:
1.varicocele patient with abdominal infection 2.varicocele patient who has massive adhesion of pelvic tissue due to pelvic surgery history 3.mild varicocele 4.varicocele patient has no obvious symptoms if has have born children, suffer from idiopathic azoospermia，or their partner can't bear children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Zhou Sun, MD，PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated hospital，Sun Yat-Sen University.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
We'll reach out to this number within 24 hrs