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临床试验/IRCT201207163820N5
IRCT201207163820N5已完成未知

Comparison of two kinds of treatment with thermal balloon and hysteroscopy in the treatment of abnormal uterine bleeding

Vice Chancellor for Research and technology, Babol University of Medical Sciences0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
70

研究概览

简要总结

Menorrhagia is one of the most common reasons for referral to gynecologists. Many women do not respond to medical treatment and are candidate for hysterectomy. Some of them who are in their middle age don’t like to have hysterectomy and those who are older are not candidate for medical treatment and surgical hysterectomy due to internal diseases in this age. So, endometrial ablation is one of suggested treatments. This clinical trial will be done on women with menorrhagia who have not responded to medical treatment. Patients are categorized into two groups: endometrial ablation with thermal balloon (intervention group, 35 patients) and endometrial ablation with hysteroscopy (control group, 25 patients). Information such as age, parity, BMI, dysmenorrhea, menstrual period, duration of menorrhagia, treatment taken, medical history, underlying disease, history of previous surgery will be recorded. Postoperative complications of hysteroscopy including bleeding, infection, uterine perforation, thermal injury, and complications after thermal balloon including thermal injury to the bowel, bleeding, uterine perforation, adenexal necrosis are recorded. All patients are followed for one year. Outcomes for each patient will be recorded for 6 months and 12 months after treatment.

研究设计

研究类型
Interventional

入排标准

年龄范围
no limit 至 no limit(—)
性别
Female

入选标准

  • 1 - no response to treatment; 2 - lack of desire for fertility and having children; 3 - normal cervical cytology; 4 - normal endometrial histology. Exclusion criteria: 1 - intrauterine pathologies (such as polyps or submocusal fibroma); 2 - Uterine cavity length more than 12 cm; 3 - hyperplasia or endometrial atypy.

排除标准

  • 未提供

研究者

发起方
Vice Chancellor for Research and technology, Babol University of Medical Sciences

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