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Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy

Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01259258
Acronym
varicocele
Enrollment
80
Registered
2010-12-14
Start date
2008-01-31
Completion date
2010-02-28
Last updated
2010-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicocele

Keywords

varicocele, methylene blue, varicocelectomy, hydrocele,

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

Interventions

PROCEDUREwithout dye varicocelectomy

40 controls in whom no mapping technique was adopted in the period between

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative complication30 dayshydrocele

Secondary

MeasureTime frameDescription
recurrence, pregnancy, semen parameterone yearrecurrence, pregnancy, semen parameter

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026