PainNCT01395186
Varicocelectomy To Treat Pain, Predictors Of Success
A study testing varicocelectomy in people with Pain, run by Mansoura University at 1 site in Egypt.
Trial summary
there are many studies studying the effectiveness of surgical treatment in patients treated for infertility, but only a few reporting the results of varicocelectomy done for pain. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- painful varicocele after failure of medical therapy
Who cannot join
- responders to medical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Varicocelectomy To Treat Pain, Predictors Of Success : A Prospective Study
there are many studies studying the effectiveness of surgical treatment in patients treated for infertility, but only a few reporting the results of varicocelectomy done for pain. This study attempted to examine the success rate of varicocele ligation when performed for the treatment of pain and to evaluate all the predictor factors that may affect the pain resolve
Read the detailed description
varicocelectomy for patients complaining of pain and studying the effectiveness and all predictors that can affect the degree of response
- Conditions
- Pain
- Being tested
- varicocelectomy
- Keywords
- varicocele, pain
- Medical subject headings
- Pain, Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varicocelectomyProcedure or surgery
Also called varicocelctomy
varicocelectomy for painful varicocele
| Study group | Role | What they receive |
|---|---|---|
| varicocelectomy | Other | varicocelectomy for patients complaining of pain Receives: Procedure: varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain resolve after varicocelectomy
degree of pain resolve after varicocelectomy
Measured: 3 months foloow up
Secondary outcomes (1)
semen parameters
count,motility, morphology based on WHO 1995
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- ramadan ellithy, md, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395186
- Sponsor's protocol ID
- Varicocelectomy To Treat Pain,
- Status last verified
- Apr 2009
- First submitted
- 11 Jul 2011
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varicocelectomy To Treat Pain, Predictors Of Success : A Prospective Study
- ClinicalTrials.gov ID
- NCT01395186
- Acronym / sponsor ID
- Varicocelectomy To Treat Pain,
- Conditions
- Pain
- Keywords
- varicocele, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
there are many studies studying the effectiveness of surgical treatment in patients treated for infertility, but only a few reporting the results of varicocelectomy done for pain. This study attempted to examine the success rate of varicocele ligation when performed for the treatment of pain and to evaluate all the predictor factors that may affect the pain resolve
Detailed description
varicocelectomy for patients complaining of pain and studying the effectiveness and all predictors that can affect the degree of response
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| varicocelectomy | Other | Procedure: varicocelectomyvaricocelectomy for patients complaining of pain |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- painful varicocele after failure of medical therapy
Key exclusion criteria (1 listed)
- responders to medical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| varicocelectomyAlso: varicocelctomyvaricocelectomy for painful varicocele | Procedure or surgery | varicocelectomy |
Primary outcome
pain resolve after varicocelectomy
Time frame: 3 months foloow up
degree of pain resolve after varicocelectomy
1 secondary outcome
semen parameters
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ramadan ellithy, md study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varicocelectomy in people with Pain, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain resolve after varicocelectomy (time frame: 3 months foloow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2011.