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OpenTrials
Completed

NCT Number: NCT01259258

Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

without dye varicocelectomy

Procedure

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

Other names: optical subinguinal varicocelectomy

Primary outcomes

  1. postoperative complication

    Time frame: 30 days

    hydrocele

Secondary outcomes

  1. recurrence, pregnancy, semen parameter

    Time frame: one year

    recurrence, pregnancy, semen parameter

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study

Acronym: varicocele

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 14, 2010
Registry last updated
Dec 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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