Management of Ovarian Masses in Pediatric Patients: an Italian Survey

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.

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Key information

Conditions

Ovarian Cysts Adnexal Diseases Cysts Diagnosis Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome

Roma, 00168, Italy

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey

Other

Questionnaire

Primary outcomes

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

Time frame: 6 months

Collect data from the survey

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: OvaMa-PEDs

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 5, 2023
Registry last updated: Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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