Management of Ovarian Masses in Pediatric Patients: an Italian Survey (OvaMa-PEDs)

March 24, 2023 updated by: Moro Francesca, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian masses' management (from diagnosis to treatment) in patients aged 1-18.

Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PURPOSE AND OBJECTIVES OF THE CLINICAL TRIAL The aim of the present study is to propose a survey among Italian Pediatric Surgeons (inside the Società Italiana di Chirurgia Pediatrica-SICP) to evaluate the current management of ovarian masses in patients aged 1 -18, in terms of preoperative work up and surgical modalities.

EXPERIMENTAL DESIGN

PRIMARY OBJECTIVE:

To evaluate the current management of ovarian masses in patients aged between 1 and 18.

EXPERIMENTAL PLAN:

Observational study, survey.

SETTING:

This is an online survey designed using REDCap forms feature. Data will be collected in a period of 6 months. The informed consent forms for participation, use of personal data and the link for the questionnaire will be sent by e-mail to all Italian Pediatric Surgeons belonging to the SICP. The surgeons who accept to participate, will return both signed consent forms and a copy of their Identity Card.

The survey is divided into seven sections.

  • Section 1: demographic data.
  • Section 2: data on surgical background of the institution and the pediatric surgeons.
  • Section 3: management of pediatric patients in emergency.
  • Section 4: management of pediatric patients who had planned surgery.
  • Section 5: additional management data.
  • Section 6: knowledge of the IOTA group and terminology.
  • Section 7: availability to participate in a multi-center retrospective study.

Questions asked for responses using yes/no, multiple-choice, or short freeform written answers. More than one response could be given for many questions, it is specified.

(The detailed description is reported in the attachment 1).

Study Type

Observational

Enrollment (Actual)

60

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

  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst.

Signed informed consent for participation in the study and for the use of personal data.

Description

Inclusion Criteria:

Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst.

Signed informed consent for participation in the study and for the use of personal data.

Exclusion Criteria No answer and/or non-completion of the questionnaire within 1 month after sending our e-mail.

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
To evaluate the current management of ovarian masses in patients aged between 1 and 18
Time Frame: 6 months
Collect data from the survey
6 months

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

June 16, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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