跳至主要内容
临床试验/CTRI/2024/06/068335
CTRI/2024/06/068335尚未招募Phase 3 4

Assessing the efficacy of combining Transcervical resection of the endometrium and Levonorgestrel intrauterine system treatment for abnormal uterine bleeding

Datta Meghe Institute of Higher Education And Research1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
1. Improvement in the menstrual bleeding pattern in patients with abnormal uterine bleeding with dysmenorrhea and without dysmenorrhea

研究概览

简要总结

Abnormal uterine bleeding (AUB) occurs in approximately 10%-35% of womenand is commonly associated with restriction of daily activity and a substantial effect on quality of life. Transcervical resection of the endometrium (TCRE) is minimally invasive, as it preserves the uterus, is associated with fewer complications, and is safer compared with hysterectomy. TCRE is widely acknowledged as the first-line surgical treatment of AUB but has a high failure rate. Studies have shown failure rates of between 21% and 36% with Levonorgestrel Intrauterine System (LNG-IUS) as a monotherapy treatment for AUB.

Women with AUB may benefit from adding LNG-IUS to TCRE. The aim of this study is to assess the effectiveness of combination treatment with TCRE + LNG-IUS compared with TCRE alone in patients with AUB with/without dysmenorrhea.

TCRE will be done with a hysteroscopic resectoscope. The first follow-up time will be one month, and the second follow-up will be three months after their initial surgery. During the follow-up period, patients will be questioned about their menstrual bleeding pattern and dysmenorrhea. Expected outcome - Combined TCRE and LNG-IUS will be superior to either treatment alone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Women having the following symptoms were considered for inclusion:
  • Menorrhagia
  • Metrorrhagia
  • Menometrorrhagia
  • Dysmenorrhea defined as cyclic pelvic pain related to menstruation.

排除标准

  • Any evidence of malignancy or hyperplasia
  • Known underlying coagulopathy
  • Postmenopausal Bleeding.

结局指标

主要结局

1. Improvement in the menstrual bleeding pattern in patients with abnormal uterine bleeding with dysmenorrhea and without dysmenorrhea

时间窗: The first follow up will be at one month, and the second follow up will be three months after the initial surgery.

2. Improvement in dysmenorrhea in patients with abnormal uterine bleeding

时间窗: The first follow up will be at one month, and the second follow up will be three months after the initial surgery.

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education And Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shrutika Satish Khapre

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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