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临床试验/NCT04936347
NCT04936347Unknown不适用

A Randomized Controlled Study of Bipolar Electric Cutting and Scissors Under Hysteroscopy in the Treatment of the Intrauterine Adhesion

Fu Xing Hospital, Capital Medical University2 个研究点 分布在 1 个国家目标入组 802 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
802
试验地点
2
主要终点
Recurrence rate

研究概览

简要总结

In this prospective, randomized controlled trial,the investigators wish to explore the difference of therapeutic effect and prognosis between "hot knife" and "cold knife" in the treatment of uterine adhesion under hysteroscopy.

详细描述

  1. Study Design:This is a prospective, randomized controlled trial.The investigators use hysteroscopy finding as standard reference.
  2. Study population 802 patients diagnosed with intrauterine adhesions(IUA)will be prospectively recruited. Before the surgery all patients will undergo preoperative evaluations, including a detailed history of the menstrual pattern,any previous intrauterine surgery, and reproductive history, as well as trans-vaginal ultrasonography.The severity and extent of intrauterine adhesions will be scored according to the ESGE IUA grades.
  3. Randomization:

Randomization was performed electronically using SPSS statistical software version 26.0 (SPSS, Inc., Chicago, IL,USA) by the investigator.802 recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: the control group("hot knife" group) and the experimental group("cold knife" group). 4. Surgical technique:

  • Hysteroscopic surgery will be performed in a standardized manner.The procedure will be performed under general anesthesia. Ultrasonographic guidance will be routinely used.
  • The interference of "cold knife" group (the experimental group) including 401 IUA patients is to perform intrauterine adhesiolysis with scissors, while the interference of "hot knife" group (the control group) is to perform intrauterine adhesiolysis with bipolar electric needle electrode, part of the scar tissue removed by electronic loop when it is necessary.
  • A Foley-catheter filled with 3.0-5.0 ml normal saline will be inserted into the uterus for 5-7 days after surgery.
  1. Postoperative treatments
  • All subjects will be treated with oral antibiotics for 5-7 days.
  • All subjects will be treated with Hormone therapy.
  • A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.
  1. Follow up:
  • Follow-up styles: the doctor's outpatient review, telephone, WeChat and so on.
  • Follow-up time:1 month, 2months, 12 months after the operation.
  • Follow up the results of hysteroscopy and the menstrual improvement and pregnancy outcomes at 12 months after the operation.
  1. Consent: All subjects will be given a detailed explanation of the study and sufficient time to consider their participation. A written consent form will be signed by the patient and retained in the records.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Indications: fertility desire, periodic pelvic pain;
  • Women aged 18-40 years;
  • Moderate to severe intrauterine adhesion(ESGE Grade II-IV);
  • All enrolled women provided written informed consent and agree to the entire study protocol prior to surgery

排除标准

  • Contraindications: such as severe medical diseases, pregnancy status, reproductive tract infection, malignant tumor;
  • History of uterine artery embolization;
  • Infertility caused by male factors or ovarian dysfunction or premature ovarian failure

结局指标

主要结局

Recurrence rate

时间窗: 2 months after surgery

Recurrence rate of intrauterine adhesions

次要结局

  • Menstrual improvement rate(2 months after surgery)
  • Pregnancy rate(1 year after the patient desire for pregnancy)

研究者

发起方
Fu Xing Hospital, Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaowu Huang

Director of department

Fu Xing Hospital, Capital Medical University

研究点 (2)

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