Contralateral Testicular Volume in Unilateral Impalpable Testis

Sponsor

Egyptian Biomedical Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT05933811

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL	Procedure: exploratory laparoscopy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pediatric patients with unilateral impalpable maldescended testis Patients in the pediatric age group who presented by unilateral impalpable undescended testis	Procedure: exploratory laparoscopy Laparoscopic exploration for impalpable maldescended testis in pediatric age group

Arm

Intervention/Treatment

Experimental: Pediatric patients with unilateral impalpable maldescended testis

Patients in the pediatric age group who presented by unilateral impalpable undescended testis

Procedure: exploratory laparoscopy

Laparoscopic exploration for impalpable maldescended testis in pediatric age group

Outcome Measures

Primary Outcome Measures

The size of the impalpable testis as examined by laparoscopy [Intraoperative]
The size of the testis in millimeters
The presence of testicular vessels of the impalpable testis as examined by laparoscopy [Intraoperative]
The presence or absence of testicular vessels
The presence of the vas deference of the impalpable testis as examined by laparoscopy [Intraoperative]
The presence or absence of the vas deference

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Pediatric patients with unilateral impalpable maldescended testis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Alexandria		Egypt	12345

Sponsors and Collaborators

Egyptian Biomedical Research Network

Investigators

Principal Investigator: Ahmed Elrouby, MD, Pediatric Surgery department

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Mar 19, 2021

More Information

Publications

None provided.

Responsible Party:

Ahmed Elrouby, Associate Professor of pediatric Surgery, Egyptian Biomedical Research Network

ClinicalTrials.gov Identifier:

NCT05933811

Other Study ID Numbers:

0305079

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 12, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Elrouby, Associate Professor of pediatric Surgery, Egyptian Biomedical Research Network

Impalpable testis

volume

Ultrasound

Study Results

No Results Posted as of Jul 12, 2023