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Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy (varicocele)

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01259258
First received: December 13, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention Phase
Varicocele
Procedure: without dye varicocelectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • postoperative complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    hydrocele


Secondary Outcome Measures:
  • recurrence, pregnancy, semen parameter [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    recurrence, pregnancy, semen parameter


Enrollment: 80
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259258

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

Publications:
Additional 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
Study First Received: December 13, 2010
Last Updated: December 13, 2010
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Varicocele
Cardiovascular Diseases
Genital Diseases, Male
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014