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

December 28, 2012 updated by: Bing Yao, First Affiliated Hospital, Sun Yat-Sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • First Affiliated hospital，Sun Yat-Sen University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: open operation
high ligation of spermatic vein by open operation
Procedure: open operation
high ligation of spermatic vein by open operation
Experimental: microsurgery
high ligation of spermatic vein by microsurgery
Procedure: microsurgery
high ligation of spermatic vein by microsurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the quality of semen and the level of sexual hormone
Time Frame: 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.
before and three and six months after surgery
complications
Time Frame: 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
one, three and six months postoperation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity
Time Frame: 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.
before and one,three and six months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
general information
Time Frame: before surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Director: Xiang Zhou Sun, MD，PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

December 31, 2012

Last Update Submitted That Met QC Criteria

December 28, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2011010005282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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