Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.

July 29, 2024 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

Estimation of the Risk of Presenting Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.

The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

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

  • Spain
    • Barcelona
      • Vilafranca Del Penedès, Barcelona, Spain, 08720
        • Consorci Sanitari Alt Penedès-Garraf

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

Sampling Method

Non-Probability Sample

Study Population

Patients previously operated on for cryptorchidism

Description

Inclusion Criteria:

  • Patients aged 13 years or older, previously operated on for cryptorchidism.

Exclusion Criteria:

  • Diagnosis of endocrine disease or any polymalformative syndrome.
  • Synchronous bilateral cryptorchidism.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contralateral Cryptorchidism
Time Frame: Up to 1 month
Proportion of patients previously operated on for cryptorchidism in whom acquired contralateral cryptorchidism is detected.
Up to 1 month

Collaborators and Investigators

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

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Investigators

  • Principal Investigator: Carme Grande Moreillo, MD, CSAPG

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)

April 1, 2024

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSAPG-63

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

IPD Sharing Time Frame

After publication of main results of the study.

IPD Sharing Access Criteria

IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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