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Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy (varicocele)

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ClinicalTrials.gov Identifier: NCT01259258
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : December 14, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Varicocele Procedure: without dye varicocelectomy Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study
Study Start Date : January 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: varicocelectomy with dye
subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation
Procedure: without dye varicocelectomy
40 controls in whom no mapping technique was adopted in the period between
Other Name: optical subinguinal varicocelectomy

Active Comparator: without dye varicocelectomy
40 controls in whom no mapping technique was adopted in the period between
Procedure: without dye varicocelectomy
40 controls in whom no mapping technique was adopted in the period between
Other Name: microoptic subinguinal varicocelectomy




Primary Outcome Measures :
  1. postoperative complication [ Time Frame: 30 days ]
    hydrocele


Secondary Outcome Measures :
  1. recurrence, pregnancy, semen parameter [ Time Frame: one year ]
    recurrence, pregnancy, semen parameter



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259258


Locations
Egypt
Mansoura University
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Study Chair: ayman elnakeeb, MD Mansoura University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: mohamed el ayed, masoura university
ClinicalTrials.gov Identifier: NCT01259258     History of Changes
Other Study ID Numbers: varicocele
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: December 14, 2010
Last Verified: November 2010

Keywords provided by Mansoura University:
varicocele, methylene blue, varicocelectomy, hydrocele,

Additional relevant MeSH terms:
Varicocele
Genital Diseases, Male
Vascular Diseases
Cardiovascular Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action