The Role of Microsurgery in Surgical Treatment of Varicocele.

NCT ID: NCT02722187

Last Updated: 2019-03-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-07-31

Brief Summary

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This study is to set the place of microsurgery in surgical treatment od varicocele in infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.

Detailed Description

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Conditions

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Varicocele Infertility

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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microsurgery

40 patients will undergo subinguinal microscopic varicocelectomy

Group Type EXPERIMENTAL

subinguinal microscopic varicocelectomy

Intervention Type PROCEDURE

laparoscopy

20 patients will undergo laparoscopic varicocelectomy

Group Type ACTIVE_COMPARATOR

laparoscopic varicocelectomy

Intervention Type PROCEDURE

Interventions

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subinguinal microscopic varicocelectomy

Intervention Type PROCEDURE

laparoscopic varicocelectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* clinical varicocele
* infertility duration of min one year
* poor semen quality
* otherwise unexplained infertility in the couple

Exclusion Criteria

* female infertility
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chair and Department of Urology Warsaw Medical University.

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Piotr DobroĊ„ski, MD PhD

Role: primary

22 502-17-02 ext. +48

References

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Diegidio P, Jhaveri JK, Ghannam S, Pinkhasov R, Shabsigh R, Fisch H. Review of current varicocelectomy techniques and their outcomes. BJU Int. 2011 Oct;108(7):1157-72. doi: 10.1111/j.1464-410X.2010.09959.x. Epub 2011 Mar 24.

Reference Type RESULT
PMID: 21435155 (View on PubMed)

Ollandini G, Liguori G, Ziaran S, Malek T, Mazzon G, de Concilio B, Bucci S, Benvenuto S, Belgrano E, Trombetta C. Varicocele treatment: a 2-centers comparison between non microsurgical open correction, laparoscopic approach and retrograde percutaneous sclerotization on 463 cases. Arch Ital Urol Androl. 2013 Sep 26;85(3):143-8. doi: 10.4081/aiua.2013.3.143.

Reference Type RESULT
PMID: 24085237 (View on PubMed)

Abdel-Meguid TA, Al-Sayyad A, Tayib A, Farsi HM. Does varicocele repair improve male infertility? An evidence-based perspective from a randomized, controlled trial. Eur Urol. 2011 Mar;59(3):455-61. doi: 10.1016/j.eururo.2010.12.008. Epub 2010 Dec 21.

Reference Type RESULT
PMID: 21196073 (View on PubMed)

Cayan S, Shavakhabov S, Kadioglu A. Treatment of palpable varicocele in infertile men: a meta-analysis to define the best technique. J Androl. 2009 Jan-Feb;30(1):33-40. doi: 10.2164/jandrol.108.005967. Epub 2008 Sep 4.

Reference Type RESULT
PMID: 18772487 (View on PubMed)

Al-Kandari AM, Shabaan H, Ibrahim HM, Elshebiny YH, Shokeir AA. Comparison of outcomes of different varicocelectomy techniques: open inguinal, laparoscopic, and subinguinal microscopic varicocelectomy: a randomized clinical trial. Urology. 2007 Mar;69(3):417-20. doi: 10.1016/j.urology.2007.01.057.

Reference Type RESULT
PMID: 17382134 (View on PubMed)

Watanabe M, Nagai A, Kusumi N, Tsuboi H, Nasu Y, Kumon H. Minimal invasiveness and effectivity of subinguinal microscopic varicocelectomy: a comparative study with retroperitoneal high and laparoscopic approaches. Int J Urol. 2005 Oct;12(10):892-8. doi: 10.1111/j.1442-2042.2005.01142.x.

Reference Type RESULT
PMID: 16323983 (View on PubMed)

Other Identifiers

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microvl/2015

Identifier Type: -

Identifier Source: org_study_id

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