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Status unknownNCT04528381Updated Aug 27, 2020

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

An interventional study of Laparoscopy in Undescended Testes, sponsored by Assiut University. Status unknown. Open to male participants aged 3 Months to 6 Years. Per ClinicalTrials.gov, last updated 2020-08-27.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
3 Months to 6 Years
Sex
Male
01

Study summary

  1. To evaluate the role of laparoscopy in diagnosis \& treatment of Non- palpable undescended testis
  2. To compare between different laparoscopic techniques
  3. To introduce new laparoscopic technique in Assuit university " shehata technique "
Read the 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

02

Conditions studied

  • Undescended Testes

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03

Who can participate

Ages eligible
3 Months to 6 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with NPT above age of 6 years
  • patients with atrophic or vanishing testis
  • patients with previous failed laparoscopic orchiopexy
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Laparoscopy

    Diagnostic and therapeutic laparoscopy

    Procedure: Laparoscopy

Interventions

  • ProcedureLaparoscopy

    Laparoscopic orchiopexy

05

What researchers measure

Primary outcomes

  1. Testicular volume

    Achievement of near normal testicular volume

    Time frame: 3 months postoperative

  2. Testicular position

    Achievement of of near normal testicular position (at scrotum )

    Time frame: 3 months postoperative

Secondary outcomes

  1. Postoperative complications

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

    Time frame: 3 months postoperative

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 29567012 ↗
  • 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. PubMed 26655212 ↗
  • 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. PubMed 23560656 ↗
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Registry details

Key details

Study ID
NCT04528381
Lead sponsor
Assiut University
Responsible party
Ahmed Abdelfattah (Resident at genaral surgery department, Assiut University) — Principal investigator
First posted
Aug 27, 2020
Start date
Aug 2020 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Oct 2022 (estimated)
Last update
Aug 27, 2020

Study contacts

Ahmed Abdelfattah
Contact
te7a53@yahoo.com
201028798792

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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