The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study

Not Applicable

• Conditions: Varicocele; Male Infertile;Varicocelectomy
• Interventions: Procedure: open operation; Procedure: microsurgery

• Registration Number: NCT01757548
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-28
• Last Update Submitted: 2012-12-28
• Study First Posted: 2012-12-31
• Last Update Posted: 2012-12-31
• Primary Completion: 2014-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open operation	open operation	high ligation of spermatic vein by open operation
microsurgery	microsurgery	high ligation of spermatic vein by microsurgery

Primary Outcome Measures

Name	Time	Method
the quality of semen and the level of sexual hormone	before and three and six months after surgery	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	one, three and six months postoperation	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

Name	Time	Method
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity	before and one,three and six months after surgery	If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity.

Trial Locations

Locations (1)

First Affiliated hospital，Sun Yat-Sen University.; 🇨🇳 Guangzhou, Guangdong, China