NCT05800613

Management of Ovarian Masses in Pediatric Patients: an Italian Survey

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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).

Conditions

• Ovarian Cysts
• Pediatric ALL
• Diagnosis

Interventions

Type	Name	Description
OTHER	Survey	Questionnaire

Timeline

• Start date: 2022-06-16
• Primary completion: 2022-11-30
• Completion: 2022-12-30
• First posted: 2023-04-05
• Last updated: 2023-04-05

Locations

1 site across 1 country: Italy