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Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy (varicocele)

M

Mansoura University

Status and phase

Completed
Phase 2

Conditions

Varicocele

Treatments

Procedure: without dye varicocelectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01259258
varicocele

Details and patient eligibility

About

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.

Full 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

Enrollment

80 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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