Contralateral Testicular Volume in Unilateral Impalpable Testis

Pediatric ALL Clinical Trial

Official title:

Does the Contralateral Testicular Volume Decide the Need for Diagnostic Laparoscopy in Cases of Unilateral Impalpable Undescended Testis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933811
• Other study ID #: 0305079
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2023
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective interventional study aimed at the preoperative sonographic estimation of the testicular volume of the normal side in case of contralateral impalpable maldescended testis in order to predict the condition of the diseased side and hence the need for diagnostic laparoscopy.

Description:

Purpose: This study aimed at the evaluation of the value of the estimated volume of a normal testis to predict the status of its contralateral impalpable side and hence decide the importance of laparoscopic exploration. Material & methods: Patients with unilateral impalpable maldescended testis - as confirmed by clinical and sonographic examination- were enrolled in this prospective interventional study between November 2018 and August 2022 at Elshatby University Hospital, Faculty of Medicine, Alexandria University. The volume and three-dimensional diameter of the normal contralateral testis were measured by the pre-operative US using the formula: Volume = L x W x H x π/6, where L is the length, W is the width, H is the height, and was correlated with the intra-operative laparoscopic findings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pediatric patients with unilateral impalpable maldescended testis

Exclusion Criteria:

• Patients with bilateral impalpable maldescended testis and those with post-operative ascended testis

Related Conditions & MeSH terms

• Pediatric ALL

Intervention

Procedure:
• exploratory laparoscopy
Laparoscopic exploration for impalpable maldescended testis in pediatric age group

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The size of the impalpable testis as examined by laparoscopy	The size of the testis in millimeters	Intraoperative
Primary	The presence of testicular vessels of the impalpable testis as examined by laparoscopy	The presence or absence of testicular vessels	Intraoperative
Primary	The presence of the vas deference of the impalpable testis as examined by laparoscopy	The presence or absence of the vas deference	Intraoperative