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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bing Yao, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01757548
First received: December 14, 2012
Last updated: December 28, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Varicocele; Male Infertile;Varicocelectomy
 Procedure: open operation
Procedure: microsurgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • the quality of semen and the level of sexual hormone [ Time Frame: before and three and six months after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one, three and six months postoperation ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: before and one,three and six months after surgery ] [ Designated as safety issue: Yes ]
    If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity.


Other Outcome Measures:
  • general information [ Time Frame: before surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1000
Study Start Date: December 2012
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757548

Locations
China, Guangdong
First Affiliated hospital，Sun Yat-Sen University.
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: Xiang Zhou Sun, MD，PhD First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Bing Yao, graduate student, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01757548     History of Changes
Other Study ID Numbers: S2011010005282
Study First Received: December 14, 2012
Last Updated: December 28, 2012
Health Authority: China: Ministry of Health

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
varicocele; male infertile;varicocelectomy

Additional relevant MeSH terms:
Infertility
Varicocele
Genital Diseases, Male
 Genital Diseases, Female
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013