Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy

Varicocele Clinical Trial

— varicocele  

Official title:

Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259258
• Other study ID #: varicocele
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2010
• Last updated: December 13, 2010
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2010
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicocele

Intervention

Procedure:
• without dye varicocelectomy
40 controls in whom no mapping technique was adopted in the period between
• without dye varicocelectomy
40 controls in whom no mapping technique was adopted in the period between

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Erratum in: J Urol. 2008 Jul;180(1):415. — View Citation

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. Epub 2006 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complication	hydrocele	30 days	Yes
Secondary	recurrence, pregnancy, semen parameter	recurrence, pregnancy, semen parameter	one year	Yes

External Links

•   mansoura university