Management of Ovarian Masses in Pediatric Patients: an Italian Survey

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05800613
Study type	Observational
Source	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status	Completed
Phase
Start date	June 16, 2022
Completion date	December 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms