Pediatric ALLNCT05933811
Contralateral Testicular Volume in Unilateral Impalpable Testis
A study testing exploratory laparoscopy in people with Pediatric ALL, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- exploratory laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric patients with unilateral impalpable maldescended testis
Who cannot join
- Patients with bilateral impalpable maldescended testis and those with post-operative ascended testis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric ALL
- Being tested
- exploratory laparoscopy
- Keywords
- Impalpable testis, volume, Ultrasound
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exploratory laparoscopyProcedure or surgery
Laparoscopic exploration for impalpable maldescended testis in pediatric age group
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with unilateral impalpable maldescended testis | Experimental | Patients in the pediatric age group who presented by unilateral impalpable undescended testis Receives: Procedure: exploratory laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The size of the impalpable testis as examined by laparoscopy
The size of the testis in millimeters
Measured: Intraoperative
The presence of testicular vessels of the impalpable testis as examined by laparoscopy
The presence or absence of testicular vessels
Measured: Intraoperative
The presence of the vas deference of the impalpable testis as examined by laparoscopy
The presence or absence of the vas deference
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Nov 2018
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ahmed Elrouby, Egyptian Biomedical Research Network
- Investigators
- Ahmed Elrouby, MD, Principal investigator, Pediatric Surgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933811
- Sponsor's protocol ID
- 0305079
- Status last verified
- Jul 2023
- First submitted
- 26 May 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38532380
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Contralateral Testicular Volume Decide the Need for Diagnostic Laparoscopy in Cases of Unilateral Impalpable Undescended Testis?
- ClinicalTrials.gov ID
- NCT05933811
- Acronym / sponsor ID
- 0305079
- Conditions
- Pediatric ALL
- Keywords
- Impalpable testis, volume, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with unilateral impalpable maldescended testis | Experimental | Procedure: exploratory laparoscopyPatients in the pediatric age group who presented by unilateral impalpable undescended testis |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pediatric patients with unilateral impalpable maldescended testis
Key exclusion criteria (1 listed)
- Patients with bilateral impalpable maldescended testis and those with post-operative ascended testis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exploratory laparoscopyLaparoscopic exploration for impalpable maldescended testis in pediatric age group | Procedure or surgery | Pediatric patients with unilateral impalpable maldescended testis |
Primary outcome
The size of the impalpable testis as examined by laparoscopy
Time frame: Intraoperative
The size of the testis in millimeters
The presence of testicular vessels of the impalpable testis as examined by laparoscopy
Time frame: Intraoperative
The presence or absence of testicular vessels
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 38532380Elrouby 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elrouby, MD principal investigator
Pediatric Surgery department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exploratory laparoscopy in people with Pediatric ALL, run by Egyptian Biomedical Research Network at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The size of the impalpable testis as examined by laparoscopy (time frame: Intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.