NCT01259258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
Last Updated

December 14, 2010

Status Verified

November 1, 2010

Enrollment Period

2.1 years

First QC Date

December 13, 2010

Last Update Submit

December 13, 2010

Conditions

Varicocele

Keywords

varicocele, methylene blue, varicocelectomy, hydrocele,

Outcome Measures

Primary Outcomes (1)

  • postoperative complication

    hydrocele

    30 days

Secondary Outcomes (1)

  • recurrence, pregnancy, semen parameter

    one year

Study Arms (2)

varicocelectomy with dye

ACTIVE COMPARATOR

subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation

Procedure: without dye varicocelectomy

without dye varicocelectomy

ACTIVE COMPARATOR

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

Procedure: without dye varicocelectomy

Interventions

without dye varicocelectomyPROCEDURE

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

Also known as: optical subinguinal varicocelectomy
varicocelectomy with dye

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all left sided varicocele with impaired sperm counts, testicular pain and/or testicular atrophy

You may not qualify if:

  • were preexisting hydrocele, previous groin surgery, concomitant hernia, allergy against methylene blue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (5)

  • Ghanem H, Anis T, El-Nashar A, Shamloul R. Subinguinal microvaricocelectomy versus retroperitoneal varicocelectomy: comparative study of complications and surgical outcome. Urology. 2004 Nov;64(5):1005-9. doi: 10.1016/j.urology.2004.06.060.

    PMID: 15533495BACKGROUND

  • Zini A, Fischer A, Bellack D, Noss M, Kamal K, Chow V, Mak V. Technical modification of microsurgical varicocelectomy can reduce operating time. Urology. 2006 Apr;67(4):803-6. doi: 10.1016/j.urology.2005.10.044. Epub 2006 Mar 29.

    PMID: 16566968BACKGROUND

  • Schwentner C, Oswald J, Lunacek A, Deibl M, Bartsch G, Radmayr C. Optimizing the outcome of microsurgical subinguinal varicocelectomy using isosulfan blue: a prospective randomized trial. J Urol. 2006 Mar;175(3 Pt 1):1049-52. doi: 10.1016/S0022-5347(05)00410-6.

    PMID: 16469616BACKGROUND

  • Atteya A, Amer M, AbdelHady A, Al-Azzizi H, Ismael E, Abdel-Gabbar M, Shamloul R. Lymphatic vessel hydrodissection during varicocelectomy. Urology. 2007 Jul;70(1):165-7. doi: 10.1016/j.urology.2007.04.012.

    PMID: 17656230BACKGROUND

  • Abd Ellatif ME, El Nakeeb A, Shoma AM, Abbas AE, Askar W, Noman N. Dye assisted lymphatic sparing subinguinal varicocelectomy. A prospective randomized study. Int J Surg. 2011;9(8):626-31. doi: 10.1016/j.ijsu.2011.07.430. Epub 2011 Aug 23.

    PMID: 21875697DERIVED

Related Links

MeSH Terms

Conditions

VaricoceleTesticular Hydrocele

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesTesticular DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • ayman elnakeeb, MD

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 14, 2010

Study Start

January 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

December 14, 2010

Record last verified: 2010-11

Locations

EG(1)