Management of Ovarian Masses in Pediatric Patients: an Italian Survey

Pediatric ALL Clinical Trial

— OvaMa-PEDs  

Official title:

Management of Ovarian Masses in Pediatric Patients: an Italian Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800613
• Other study ID #: 5003
• Status: Completed
• Start date: June 16, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis
• Ovarian Cysts
• Pediatric ALL

Intervention

Other:
• Survey
Questionnaire

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the current management of ovarian masses in patients aged between 1 and 18	Collect data from the survey	6 months