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Completed

NCT Number: NCT05933811

Contralateral Testicular Volume in Unilateral Impalpable 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.

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Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Alexandria, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients with unilateral impalpable maldescended testis

Exclusion criteria

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

Treatment and study plan

exploratory laparoscopy

Procedure

Laparoscopic exploration for impalpable maldescended testis in pediatric age group

Primary outcomes

  1. The size of the impalpable testis as examined by laparoscopy

    Time frame: Intraoperative

    The size of the testis in millimeters

  2. The presence of testicular vessels of the impalpable testis as examined by laparoscopy

    Time frame: Intraoperative

    The presence or absence of testicular vessels

  3. 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

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2023
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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