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

Undescended Testes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04528381
• Other study ID #: Laparoscopy in NPT
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: October 2022

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: Ahmed Abdelfattah
• Phone: 201028798792
• Email: te7a53[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 "

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryptorchidism
• Undescended Testes

Intervention

Procedure:
• Laparoscopy
Laparoscopic orchiopexy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testicular volume	Achievement of near normal testicular volume	3 months postoperative
Primary	Testicular position	Achievement of of near normal testicular position (at scrotum )	3 months postoperative
Secondary	Postoperative complications	Bleeding , damage of vas and/or blood supply and reascent	3 months postoperative