Contralateral Testicular Volume in Unilateral Impalpable Testis

NCT ID: NCT05933811

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric ALL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pediatric patients with unilateral impalpable maldescended testis

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

Group Type EXPERIMENTAL

exploratory laparoscopy

Intervention Type PROCEDURE

Laparoscopic exploration for impalpable maldescended testis in pediatric age group

Interventions

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exploratory laparoscopy

Laparoscopic exploration for impalpable maldescended testis in pediatric age group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients with unilateral impalpable maldescended testis

Exclusion Criteria

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

MALE

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Biomedical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Ahmed Elrouby

Associate Professor of pediatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Elrouby, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Surgery department

Locations

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Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Elrouby A, Ghalab M, Kotb M. Does the contralateral testicular volume decide the need for diagnostic laparoscopy in cases of unilateral impalpable undescended testis? BMC Urol. 2024 Mar 26;24(1):68. doi: 10.1186/s12894-024-01455-2.

Reference Type DERIVED
PMID: 38532380 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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0305079

Identifier Type: -

Identifier Source: org_study_id

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