Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES

Adnexal Mass Clinical Trial

Official title: Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES

Status Recruiting

Clinical Trial Summary

To review the characteristic, presentation and outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.

Clinical Trial Description

Background, current evidence and key references:

In paediatric and adolescent girls, preservation of the ovaries for those suffering from ovarian masses requiring surgery is important to maximize future fertility. However, when one faces an ovarian mass in a girl, on one hand, there is potential fertility compromise in those who had extensive ovarian surgery, on the other hand there is a small but non-negligible potential malignancy risk. There are distinct differences in pathologies and imaging findings in girls compared to adults. There arises the question on the most suitable way to triage children for the suitable management, be it conservative, ovarian preserving or more radical surgery.

There have been different diagnostic tools developed to aid the evaluation of adnexal masses in women with only limited evidence on the usage of these tools when being applied to the paediatric and adolescent age group. Attempts have been made in creating treatment guidelines for children, however no prospective randomized trials exist in this area. Therefore, it is important to identify and develop the most suitable triage algorithm for this group of patients.

Aim of study:

In this study, we aim to review the presentation, participant characteristics, imaging findings and histopathological findings, and validate the applicability of the various diagnostic tools in the paediatric and adolescent population to hopefully develop a management algorithm to improve the ovarian preservation rate without jeopardizing the potential malignancy risk in girls with adnexal masses.

Aim to look at whether adult scoring systems for adnexal mass can be applied to the paediatric and adolescent population to differentiate between benign and malignant adnexal masses.

Hypothesis:

The current diagnostic algorithms available for adults are applicable to the paediatric and adolescent population.

Outcome measure:

Participant characteristics, imaging findings, biochemical markers, operative record and histopathological findings, post-operative complications, post-operative menstrual symptoms, and any subsequent reproductive outcome.

Methods of Data Analysis:

The presentation, characteristics, imaging prior to surgery, surgical approaches, histopathological diagnosis and outcome of participant who presented with adnexal masses will be reviewed. The findings according to the data obtained from the review of medical records will be compared to the pre-existing rules and management algorithm for adults. The scoring systems or algorithms will then be validated with histopathological findings or participant outcome to assess applicability in our study population.

SPSS statistical program (SPSS Inc. version 21; IBM Corp., Armonk, NY, USA) was used to analyse the data collected. Normally distributed data was described using means (SD), whereas non-normally distributed data were described using medians (range).

A probability value of <0.05 was considered statistically significant. ;

Related Conditions & MeSH terms

• Adnexal Mass

• NCT number: NCT05461872
• Study type: Observational
• Source: Chinese University of Hong Kong
• Contact: KAREN NG, PI
• Phone: 852-96144255
• Email: ngkaren@cuhk.edu.hk
• Status: Recruiting
• Start date: August 12, 2022
• Completion date: December 31, 2023