NCT05933811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

3.8 years

First QC Date

May 26, 2023

Last Update Submit

July 10, 2023

Conditions

Pediatric ALL

Keywords

Impalpable testisvolumeUltrasound

Outcome Measures

Primary Outcomes (3)

  • The size of the impalpable testis as examined by laparoscopy

    The size of the testis in millimeters

    Intraoperative

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

    The presence or absence of testicular vessels

    Intraoperative

  • The presence of the vas deference of the impalpable testis as examined by laparoscopy

    The presence or absence of the vas deference

    Intraoperative

Study Arms (1)

Pediatric patients with unilateral impalpable maldescended testis

EXPERIMENTAL

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

Procedure: exploratory laparoscopy

Interventions

exploratory laparoscopyPROCEDURE

Laparoscopic exploration for impalpable maldescended testis in pediatric age group

Pediatric patients with unilateral impalpable maldescended testis

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatric patients with unilateral impalpable maldescended testis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, 12345, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 38532380DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ahmed Elrouby, MD

    Pediatric Surgery department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of pediatric Surgery

Study Record Dates

First Submitted

May 26, 2023

First Posted

July 6, 2023

Study Start

November 1, 2018

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

EG(1)