Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy (varicocele)
Primary Purpose
Varicocele
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
without dye varicocelectomy
without dye varicocelectomy
Sponsored by
About this trial
This is an interventional treatment trial for Varicocele focused on measuring varicocele, methylene blue, varicocelectomy, hydrocele,
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
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
varicocelectomy with dye
without dye varicocelectomy
Arm Description
subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation
40 controls in whom no mapping technique was adopted in the period between
Outcomes
Primary Outcome Measures
postoperative complication
hydrocele
Secondary Outcome Measures
recurrence, pregnancy, semen parameter
recurrence, pregnancy, semen parameter
Full Information
NCT ID
NCT01259258
First Posted
December 13, 2010
Last Updated
December 13, 2010
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT01259258
Brief Title
Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy
Acronym
varicocele
Official Title
Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele
Keywords
varicocele, methylene blue, varicocelectomy, hydrocele,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
varicocelectomy with dye
Arm Type
Active Comparator
Arm Description
subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation
Arm Title
without dye varicocelectomy
Arm Type
Active Comparator
Arm Description
40 controls in whom no mapping technique was adopted in the period between
Intervention Type
Procedure
Intervention Name(s)
without dye varicocelectomy
Other Intervention Name(s)
optical subinguinal varicocelectomy
Intervention Description
40 controls in whom no mapping technique was adopted in the period between
Intervention Type
Procedure
Intervention Name(s)
without dye varicocelectomy
Other Intervention Name(s)
microoptic subinguinal varicocelectomy
Intervention Description
40 controls in whom no mapping technique was adopted in the period between
Primary Outcome Measure Information:
Title
postoperative complication
Description
hydrocele
Time Frame
30 days
Secondary Outcome Measure Information:
Title
recurrence, pregnancy, semen parameter
Description
recurrence, pregnancy, semen parameter
Time Frame
one year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman elnakeeb, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
15533495
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.
Results Reference
background
PubMed Identifier
16566968
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.
Results Reference
background
PubMed Identifier
16469616
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. Erratum In: J Urol. 2008 Jul;180(1):415.
Results Reference
background
PubMed Identifier
17656230
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.
Results Reference
background
PubMed Identifier
21875697
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.
Results Reference
derived
Links:
URL
http://www.mans.edu.eg/
Description
mansoura university
Learn more about this trial
Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy
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