Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy

Phase 2

Completed

• Conditions: Varicocele
• Interventions: Procedure: without dye varicocelectomy

• Registration Number: NCT01259258
• Lead Sponsor: Mansoura University

Brief Summary

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

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

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-11
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Last Update Submitted: 2010-12-13
• Study First Posted: 2010-12-14
• Last Update Posted: 2010-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
varicocelectomy with dye	without dye varicocelectomy	subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation
without dye varicocelectomy	without dye varicocelectomy	40 controls in whom no mapping technique was adopted in the period between

Primary Outcome Measures

Name	Time	Method
postoperative complication	30 days	hydrocele

Secondary Outcome Measures

Name	Time	Method
recurrence, pregnancy, semen parameter	one year	recurrence, pregnancy, semen parameter

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt