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临床试验/CTRI/2023/12/060484
CTRI/2023/12/060484尚未招募不适用

Correlation of clinical manifestations of adenomyosis with revised Morphological Ultrasonographic Assessment (MUSA) features.

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2023年12月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
107
试验地点
1
主要终点
1. Correlation of pain score (NRS4) with direct/indirect features, number of features, site and extent of adenomyosis

研究概览

简要总结

Adenomyosis is defined as a benign uterine pathology in which there is presence of endometrium glands and stroma in the myometrium1. It can either be a focal or a diffuse lesion in inner or outer myometrium. A classical histological definition for adenomyosis is the invasion of the myometrium by endometrial glands and/or stroma, deeper than 2.5 mm from the endometrial –myometrial junction, accompanied by adjacent smooth muscle hyperplasia. It is commonly found among the age group of 35-50 years2.The prevalence of adenomyosis is difficult to estimate due to the existence of asymptomatic variants and varied diagnostic techniques (histological or imaging). The prevalence is estimated to be on the order of 20-30% based on a series of patients treated by hysterectomy, however there is a significant degree of heterogeneity in this estimation, ranging from 5% to 70%­­3.

It[ss1]  is hard to associate one pathognomonic feature to the presence of adenomyosis.

Common symptoms associated with the condition can include pelvic pain (dysmenorrhea, dyspareunia, chronic pelvic pain), abnormal uterine bleeding and reduced reproductive potential. Although about 30% of the patients with adenomyosis are asymptomatic4. Traditionally it was diagnosed mainly on histological specimens obtained after surgical intervention. However, with recent advances in the field of non-invasive diagnostic tools, modalities like Magnetic Resonance Imaging (MRI) and Transvaginal Ultrasonography (TVUS) have made it possible to make diagnosis of adenomyosis, prior to surgical intervention. A consensus on the terminology to use when characterizing ultrasound pictures of adenomyosis was released in 2015 by the worldwide Morphological Uterus Sonographic Assessment (MUSA) group5. A standard categorization and reporting system for adenomyosis’s morphological variants and its ultrasound-based extent was proposed by the MUSA group in 20196. The definitions of MUSA features of adenomyosis were revised in 2022. The distinction between direct and indirect signs and its correlation with symptoms of adenomyosis like pain, bleeding and subfertility can help facilitate recognition and diagnosis of adenomyosis in clinical practice7.

The relation between direct and indirect MUSA characteristics of adenomyosis, as well as the correlation of disease location, extent, and size with clinical symptoms and therapeutic effects needs to be further evaluated using prospective studies.

Lack of prospective studies to link revised MUSA ultra-sonographic features with the clinical symptom forms the lacunae in the existing knowledge. Therefore, we aim to conduct a study to establish the correlation of one or more direct or indirect features of adenomyosis (as per revised MUSA definitions) and clinical outcomes as well as the association between number, size of features and their location (with relation to the junctional zone or layer of involvement) and clinical symptoms.


[ss1]Prevalence, general, infertility

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients presenting with symptoms of dysmenorrhea/HMB/ and Diagnosed to have adenomyosis based on  1 ultrasound features of adenomyosis as per revised MUSA criteria Willing to give informed written consent.

排除标准

  • Coexisting fibroid (Fibroid >5 cm or FIGO type 0,1,2) Coexisting endometriosis Women using contraceptives or taking hormonal medications within 3 months of recruitment Not willing to give consent for the study.

结局指标

主要结局

1. Correlation of pain score (NRS4) with direct/indirect features, number of features, site and extent of adenomyosis

时间窗: patient assessment at a given point only, no follow up required

2. Correlation of total menstrual loss by PBAC(PBAC100) with direct/indirect features, number of features, site and extent of adenomyosis

时间窗: patient assessment at a given point only, no follow up required

次要结局

  • 1. To correlate type of feature, number of features, site and extent of adenomyosis with quality of life(zero weeks)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shivangi Singh

AIIMS New Delhi

研究点 (1)

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