Clinical trial NCT01259258: Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy
Official title: Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Varicocele
Keywords: varicocele, methylene blue, varicocelectomy, hydrocele,
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: postoperative complication
timeFrame: 30 days
Secondary outcomes:
measure: recurrence, pregnancy, semen parameter
timeFrame: one year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: ayman elnakeeb, MD
role: STUDY_CHAIR
References:
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. doi: 10.1016/j.urology.2004.06.060.
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. doi: 10.1016/j.urology.2005.10.044. Epub 2006 Mar 29.
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. doi: 10.1016/S0022-5347(05)00410-6.
citation: 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.
citation: 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.