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Single Incision Laparoscopic Varicocelectomy

Primary Purpose

Varicocele

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single incision laparoscopic varicocelectomy
conventional transperitoneal laparoscopic varicocelectomy
Sponsored by
Mansoura University
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:

  • patients with palpable varicoceles

Exclusion Criteria:

  • unfit for anesthesia or laparoscopy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    SIL-V

    CTL-V

    Arm Description

    single incision laparoscopic varicocelectomy

    conventional transperitoneal laparoscopic varicocelectomy

    Outcomes

    Primary Outcome Measures

    number of patients with improvement in semen parameters and resolution of testicular pain

    Secondary Outcome Measures

    number of patients developing postoperative complications

    Full Information

    First Posted
    January 7, 2015
    Last Updated
    January 7, 2015
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02335385
    Brief Title
    Single Incision Laparoscopic Varicocelectomy
    Official Title
    Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds. Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SIL-V
    Arm Type
    Active Comparator
    Arm Description
    single incision laparoscopic varicocelectomy
    Arm Title
    CTL-V
    Arm Type
    Active Comparator
    Arm Description
    conventional transperitoneal laparoscopic varicocelectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    single incision laparoscopic varicocelectomy
    Intervention Description
    bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional transperitoneal laparoscopic varicocelectomy
    Intervention Description
    bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy
    Primary Outcome Measure Information:
    Title
    number of patients with improvement in semen parameters and resolution of testicular pain
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    number of patients developing postoperative complications
    Time Frame
    2 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with palpable varicoceles Exclusion Criteria: unfit for anesthesia or laparoscopy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25937155
    Citation
    Youssef T, Abdalla E. Single incision transumbilical laparoscopic varicocelectomy versus the conventional laparoscopic technique: A randomized clinical study. Int J Surg. 2015 Jun;18:178-83. doi: 10.1016/j.ijsu.2015.04.048. Epub 2015 May 1. Erratum In: Int J Surg. 2015 Aug;20:170.
    Results Reference
    derived

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