Varicocele; Male Infertile;Varicocelectomy Clinical Trial
Official title:
The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
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.
| Status | Active, not recruiting |
| Enrollment | 1000 |
| Est. completion date | November 2020 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 10 Years to 50 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | First Affiliated hospital,Sun Yat-Sen University. | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | general information | 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 | before surgery | No |
| Primary | 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. | before and three and six months after surgery | Yes |
| Primary | 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 | one, three and six months postoperation | Yes |
| Secondary | 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. | before and one,three and six months after surgery | Yes |