Clinical trial NCT05800613: Management of Ovarian Masses in Pediatric Patients: an Italian Survey
Official title: Management of Ovarian Masses in Pediatric Patients: an Italian Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cysts
Pediatric ALL
Diagnosis
Keywords: ovarian cysts
Pediatric patients
Ultrasound
Survey
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the current management of ovarian masses in patients aged between 1 and 18
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome
Study officials:
References: