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
About this trial
This is an interventional treatment trial for Undescended Testes
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
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
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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