The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 14, 2012
CompletedFirst Posted
Study publicly available on registry
December 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedDecember 31, 2012
December 1, 2012
1.9 years
December 14, 2012
December 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (1)
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
Other Outcomes (1)
general information
before surgery
Study Arms (2)
open operation
EXPERIMENTALhigh ligation of spermatic vein by open operation
microsurgery
EXPERIMENTALhigh ligation of spermatic vein by microsurgery
Interventions
Eligibility Criteria
You may qualify if:
- infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated hospital，Sun Yat-Sen University.
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiang Zhou Sun, MD，PhD
First Affiliated Hospital, Sun Yat-Sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- graduate student
Study Record Dates
First Submitted
December 14, 2012
First Posted
December 31, 2012
Study Start
December 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2020
Last Updated
December 31, 2012
Record last verified: 2012-12