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Management of Ovarian Masses in Pediatric Patients: an Italian Survey

Management of Ovarian Masses in Pediatric Patients: an Italian Survey

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05800613
Acronym
OvaMa-PEDs
Enrollment
60
Registered
2023-04-05
Start date
2022-06-16
Completion date
2022-12-30
Last updated
2023-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Ovarian Cysts, Pediatric ALL

Keywords

ovarian cysts, Pediatric patients, Ultrasound, Survey

Brief summary

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.

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).

Interventions

OTHERSurvey

Questionnaire

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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.

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the current management of ovarian masses in patients aged between 1 and 186 monthsCollect data from the survey

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026