An observational study in Adnexal Mass, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to female participants aged 1 Day to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-15.
Sponsored by Chinese University of Hong Kong · Observational
To review the characteristic, presentation and outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
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.
Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Expecting number of record will be reviewed: 300.
Participant will be identified from review of clinical records.
Participants aged 21 or below who attended the NTEC cluster from 1990-2021 with available medical records.
Since not all data are available in each case, expecting 300 patient records will be reviewed to have target 139 completed record.
Total number of females from HK census in 2021: 0-19 years old: 521857 9-11% are malignant
Sample size calculation work with a 95% confidence level; Confidence interval (margin of error) of ± 5%; Population portion of 10% Population size: 521857
Sample size=139
Exclusion Criteria:
All girls who presented with adnexal mass from 0-21 years old (inclusive). Subjects will be identified from review of clinical records. Girl aged 21 or below who attended the NTEC cluster from 1990-2021 with available medical records.
Other: No intervention
No intervention
To review the characteristic of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the characteristic of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
To review the imaging findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the imaging findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
To review the biochemical markers of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the biochemical markers of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
To review the operative record of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the operative record of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
To review the histopathological findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the histopathological findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
To review the post-operative complications of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the post-operative complications of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
To review the post-operative menstrual symptoms of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the post-operative menstrual symptoms of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
To review the subsequent reproductive outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
To review the subsequent reproductive outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time frame: Baseline
Plan to share: Undecided
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong