跳至主要内容
临床试验/NCT06122363
NCT06122363进行中(未招募)不适用

The Impact of Incomplete Endometrial Ablation on the Success Rate of Novasure Endometrial Ablation

Maxima Medical Center1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
121
试验地点
1
主要终点
Pictorial Blood Assessment Chart (PBAC) score

研究概览

简要总结

The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.

详细描述

The primary outcome is blood loss at 24 months after treatment, measured with the PBAC-score according to Higham. To calculate this score women were asked, in the MIRA and MIRA2 study, to record their menstrual blood loss for one month counting the number of super tampons or pads used each day. The total score was calculated using a score of 1 for each lightly saturated tampons. For pads the scores were respectively 1, 5 and 20. Secondary outcome measures were controlled bleeding, defined as a PBAC-score not exceeding 75 points, PBAC score of zero, re-intervention rate 24 months after treatment, satisfaction with treatment (measured with a 5-point Likert scale) and dysmenorrhea.

In addition, multiple variables were analyzed in predicting the occurrence of incomplete endometrial ablation, including age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization. Information was collected from EPD and the MIRA and MIRA2 databases.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Endometrial ablation between 2012 and 2023 in Máxima Medical Centre
  • Women had to suffer from heavy menstrual bleeding

排除标准

  • No saved hysteroscopy images or bad quality hysteroscopy images

结局指标

主要结局

Pictorial Blood Assessment Chart (PBAC) score

时间窗: 24 months

Blood loss of 1 month, measured by the number of needed tampons/pads and how heavily they are filled with blood. The higher the score, the more severe blood loss. From 150 points the amount is defined as heavy menstrual bleeding.

次要结局

  • Satisfaction of the patient with the treatment(24 months)
  • Rate of reintervention(24 months)
  • Number of patients having controlled bleeding(24 months)
  • Dysmennorrhea(24 months)

研究者

发起方
Maxima Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danique Roelen

Medical student

Maxima Medical Center

研究点 (1)

Loading locations...

相似试验