Contralateral Testicular Volume in Unilateral Impalpable Testis

July 10, 2023 updated by: Ahmed Elrouby, Egyptian Biomedical Research Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 12345
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric patients with unilateral impalpable maldescended testis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The size of the impalpable testis as examined by laparoscopy
Time Frame: Intraoperative
The size of the testis in millimeters
Intraoperative
The presence of testicular vessels of the impalpable testis as examined by laparoscopy
Time Frame: Intraoperative
The presence or absence of testicular vessels
Intraoperative
The presence of the vas deference of the impalpable testis as examined by laparoscopy
Time Frame: Intraoperative
The presence or absence of the vas deference
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egyptian Biomedical Research Network

Investigators

  • Principal Investigator: Ahmed Elrouby, MD, Pediatric Surgery department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0305079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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