Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy (varicocele)

Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Varicocele
• Intervention / Treatment: Procedure: without dye 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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: microoptic 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 Names: microoptic subinguinal varicocelectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complication	hydrocele	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence, pregnancy, semen parameter	recurrence, pregnancy, semen parameter	one year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: ayman elnakeeb, MD, Mansoura University

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: J Urol. 2008 Jul;180(1):415.
• 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.
• 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.

Helpful Links

• mansoura university

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (ESTIMATE): December 14, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: varicocele, methylene blue, varicocelectomy, hydrocele,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicocele
• Other Study ID Numbers: varicocele