Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy

NCT ID: NCT01259258

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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

Conditions

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Varicocele

Keywords

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varicocele, methylene blue, varicocelectomy, hydrocele,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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varicocelectomy with dye

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

Group Type ACTIVE_COMPARATOR

without dye varicocelectomy

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

without dye varicocelectomy

Intervention Type PROCEDURE

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

Interventions

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without dye varicocelectomy

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

Intervention Type PROCEDURE

without dye varicocelectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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optical subinguinal varicocelectomy microoptic subinguinal varicocelectomy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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masoura university

Principal Investigators

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ayman elnakeeb, MD

Role: STUDY_CHAIR

Mansoura University

Locations

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Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 15533495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16566968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16469616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17656230 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21875697 (View on PubMed)

Related Links

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http://www.mans.edu.eg/

mansoura university

Other Identifiers

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varicocele

Identifier Type: -

Identifier Source: org_study_id