Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy

Study Overview
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Brief Summary
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We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between January 2008 and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months.

Detailed Description
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Methods. We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between January 2008 and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months. Results: There were no intraoperative complications in either group. There were no adverse reactions, scrotal haematomas or atrophy. In group 1, no patient had a hydrocele at 3 months after surgery. By contrast, in group 2 (surgery alone) there were four cases of secondary hydrocele (10%; P=0.025)); no testicular hypertrophy was observed following lymphatic sparing surgery , One patient in each group had varicocele recurrence. Pregnancy was reported in 30 patients (37.5%) during a follow up period, 17 of them (42.5%) were group(1),P >0.34. difference was not significantly different among the two groups

Official Title
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Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study

Conditions
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Varicocele

Intervention / Treatment
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* Procedure: without dye varicocelectomy
* Procedure: without dye varicocelectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all left sided varicocele with impaired sperm counts, testicular pain and/or testicular atrophy Exclusion Criteria: were preexisting hydrocele, previous groin surgery, concomitant hernia, allergy against methylene blue

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: varicocelectomy with dye<br>subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation | Procedure: without dye varicocelectomy<br>* 40 controls in whom no mapping technique was adopted in the period between<br>* Other names: optical subinguinal varicocelectomy;|
| Active Comparator: without dye varicocelectomy<br>40 controls in whom no mapping technique was adopted in the period between | Procedure: without dye varicocelectomy<br>* 40 controls in whom no mapping technique was adopted in the period between<br>* Other names: microoptic subinguinal varicocelectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complication | hydrocele | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence, pregnancy, semen parameter | recurrence, pregnancy, semen parameter | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicocele, methylene blue, varicocelectomy, hydrocele,