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Role of Laparoscopy in Management of Non-palpable Undescended Testis : Assuit University Experience

Primary Purpose

Undescended Testes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Undescended Testes

Eligibility Criteria

3 Months - 6 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • any patient admitted to pediatric unit in Assuit University hospital with non palpable testis ( NPT )below age of 6 years

Exclusion Criteria:

  • patients with NPT above age of 6 years
  • patients with atrophic or vanishing testis
  • patients with previous failed laparoscopic orchiopexy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Laparoscopy

    Arm Description

    Diagnostic and therapeutic laparoscopy

    Outcomes

    Primary Outcome Measures

    Testicular volume
    Achievement of near normal testicular volume
    Testicular position
    Achievement of of near normal testicular position (at scrotum )

    Secondary Outcome Measures

    Postoperative complications
    Bleeding , damage of vas and/or blood supply and reascent

    Full Information

    First Posted
    August 23, 2020
    Last Updated
    August 23, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04528381
    Brief Title
    Role of Laparoscopy in Management of Non-palpable Undescended Testis : Assuit University Experience
    Official Title
    Role of Laparoscopy in Management of Non-palpable Undescended Testis : Assuit University Experience
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the role of laparoscopy in diagnosis & treatment of Non- palpable undescended testis To compare between different laparoscopic techniques To introduce new laparoscopic technique in Assuit university " shehata technique "
    Detailed Description
    Cryptorchidism or undescended testis (UDT) is one of the most common genital anomalies in childhood. Its incidence is 3-5 % in full term newborn, and affect more than one third of premature newborn. The incidence decrease to 1 % at age of 3months. About 20% of UDT are impalpable, and about 50% of these impalpable testes are either vanished or atrophic (1-3). Many diagnostic methods have been used for the evaluation and management of the undescended testis, including imaging studies and multiple surgical procedures. Surgical management of UDT is performed to preserve testicular function (spermatogenesis) and to prevent the potential complications of undescended testis(1). Regarding the optimal age of orchiopexy many recent findings suggest that early intervention (6 -12 months of age) is most beneficial. Other findings suggest that there is high rate of spontaneous descent during the first 3 months of life, so observation of undescended testis is advocated till 3 months of age, if the testis remains non-palpable at 3 months of age, it is unlikely to become palpable by waiting another 3 months. Therefore, diagnostic laparoscopy and orchidopexy could be performed from 3 months of age(2). For intraabdominal cryptorchidism, laparoscopic surgery has been accepted by most surgeons as the preferred technique for diagnosis & treatment (4). Laparoscopic findings in non-palpable testis include ; Absent testis either ; Agenesis ( absence of spermatic vessels and vas deferens ) or vanishing testis ( blind ending of spermatic vessels or vas ) , Canalicular testis ; Penetration of vas and spermatic vessels into the internal inguinal ring with or without directly seeing the testis , Abdominal testis Localized between the inferior renal pole and the ipsilateral internal inguinal ring. Can be low (< 2cm) or high (>2cm) from internal inguinal ring , Peeping ; Primarily in intra-abdominal position. The testis introduces itself into the inguinal canal due to the intra-abdominal pressure augmentation during the laparoscopic procedure.(5) Several techniques have been described for treatment of intra-abdominal testis including microsurgical auto-transplantation, primary laparoscopic orchiopexy (VILO), one- and two-stage laparoscopic Fowler-Stephens procedures, and staged laparoscopic traction orchiopexy (Shehata technique

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective & retrospective
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopy
    Arm Type
    Other
    Arm Description
    Diagnostic and therapeutic laparoscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopy
    Intervention Description
    Laparoscopic orchiopexy
    Primary Outcome Measure Information:
    Title
    Testicular volume
    Description
    Achievement of near normal testicular volume
    Time Frame
    3 months postoperative
    Title
    Testicular position
    Description
    Achievement of of near normal testicular position (at scrotum )
    Time Frame
    3 months postoperative
    Secondary Outcome Measure Information:
    Title
    Postoperative complications
    Description
    Bleeding , damage of vas and/or blood supply and reascent
    Time Frame
    3 months postoperative

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: any patient admitted to pediatric unit in Assuit University hospital with non palpable testis ( NPT )below age of 6 years Exclusion Criteria: patients with NPT above age of 6 years patients with atrophic or vanishing testis patients with previous failed laparoscopic orchiopexy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abdelfattah
    Phone
    201028798792
    Email
    te7a53@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29567012
    Citation
    Elsherbeny M, Abdallah A, Abouzeid A, Ghanem W, Zaki A. Staged laparoscopic traction orchiopexy for intra-abdominal testis: Is it always feasible? J Pediatr Urol. 2018 Jun;14(3):267.e1-267.e4. doi: 10.1016/j.jpurol.2018.01.021. Epub 2018 Mar 2.
    Results Reference
    background
    PubMed Identifier
    26655212
    Citation
    Shehata S, Shalaby R, Ismail M, Abouheba M, Elrouby A. Staged laparoscopic traction-orchiopexy for intraabdominal testis (Shehata technique): Stretching the limits for preservation of testicular vasculature. J Pediatr Surg. 2016 Feb;51(2):211-5. doi: 10.1016/j.jpedsurg.2015.10.063. Epub 2015 Nov 4.
    Results Reference
    background
    PubMed Identifier
    23560656
    Citation
    Powell C, McIntosh J, Murphy JP, Gatti J. Laparoscopic orchiopexy for intra-abdominal testes-a single institution review. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):481-3. doi: 10.1089/lap.2012.0578. Epub 2013 Apr 6.
    Results Reference
    background

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    Role of Laparoscopy in Management of Non-palpable Undescended Testis : Assuit University Experience

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