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

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 "

Study Overview

• Status: Unknown
• Conditions: Undescended Testes
• Intervention / Treatment: Procedure: Laparoscopy

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abdelfattah; Phone Number: 201028798792; Email: te7a53@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Laparoscopy; Diagnostic and therapeutic laparoscopy	Procedure: Laparoscopy; Laparoscopic orchiopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testicular volume	Achievement of near normal testicular volume	3 months postoperative
Testicular position	Achievement of of near normal testicular position (at scrotum )	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Bleeding , damage of vas and/or blood supply and reascent	3 months postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Urogenital Abnormalities; Congenital Abnormalities; Testicular Diseases; Cryptorchidism
• Other Study ID Numbers: Laparoscopy in NPT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No