Varicocelectomy To Treat Pain, Predictors Of Success | NCT01395186

Studies
Varicocelectomy To Treat Pain, Predictors Of Success

NCT01395186

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Jul 15, 2011Estimated

Enrollment

145Actual

Phase

Not Applicable

Conditions

Pain

Interventions

varicocelectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 14, 2011

First Posted Date

Jul 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2011

Last Update Posted Date

Jul 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
varicocelectomy	Other	varicocelectomy for patients complaining of pain	Procedure: varicocelectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
varicocelectomy	Procedure	varicocelectomy for painful varicocele	varicocelectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain resolve after varicocelectomy	degree of pain resolve after varicocelectomy	3 months foloow up

Secondary Outcomes

Measure	Description	Time Frame
semen parameters	count,motility, morphology based on WHO 1995	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

painful varicocele after failure of medical therapy

Exclusion Criteria:

responders to medical therapy

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ramadan ellithy, md	Mansoura University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University		Al Mansurah		35516	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D014646	Varicocele

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided