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The Role of Microsurgery in Surgical Treatment of Varicocele.

Primary Purpose

Varicocele, Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
subinguinal microscopic varicocelectomy
laparoscopic varicocelectomy
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicocele

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • female infertility

Sites / Locations

  • Chair and Department of Urology Warsaw Medical University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

microsurgery

laparoscopy

Arm Description

40 patients will undergo subinguinal microscopic varicocelectomy

20 patients will undergo laparoscopic varicocelectomy

Outcomes

Primary Outcome Measures

pregnancy rate after the intervention

Secondary Outcome Measures

Full Information

First Posted
March 24, 2016
Last Updated
March 4, 2019
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02722187
Brief Title
The Role of Microsurgery in Surgical Treatment of Varicocele.
Official Title
The Role of Microsurgery in Surgical Treatment of Varicocele.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele, Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
microsurgery
Arm Type
Experimental
Arm Description
40 patients will undergo subinguinal microscopic varicocelectomy
Arm Title
laparoscopy
Arm Type
Active Comparator
Arm Description
20 patients will undergo laparoscopic varicocelectomy
Intervention Type
Procedure
Intervention Name(s)
subinguinal microscopic varicocelectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic varicocelectomy
Primary Outcome Measure Information:
Title
pregnancy rate after the intervention
Time Frame
one yaer after the intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical varicocele infertility duration of min one year poor semen quality otherwise unexplained infertility in the couple Exclusion Criteria: female infertility
Facility Information:
Facility Name
Chair and Department of Urology Warsaw Medical University.
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Dobroński, MD PhD
Phone
22 502-17-02
Ext
+48
Email
urologia@wum.edu.pl

12. IPD Sharing Statement

Citations:
PubMed Identifier
21435155
Citation
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.
Results Reference
result
PubMed Identifier
24085237
Citation
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.
Results Reference
result
PubMed Identifier
21196073
Citation
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.
Results Reference
result
PubMed Identifier
18772487
Citation
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.
Results Reference
result
PubMed Identifier
17382134
Citation
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.
Results Reference
result
PubMed Identifier
16323983
Citation
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.
Results Reference
result

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The Role of Microsurgery in Surgical Treatment of Varicocele.

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