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临床试验/NCT02590666
NCT02590666Unknown不适用

Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

University of Cagliari0 个研究点目标入组 40 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
To assess the tolerability of polypectomy using a validated visual analogue pain scale

研究概览

简要总结

Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted.

The aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .

Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •The patient must be informed about the study, and sign the informed consent

排除标准

  • •Positive Pap smear test
  • •Pregnancy
  • •Uterine malignancy
  • •Abnormal uterine bleeding

研究组 & 干预措施

Bipolar electrode

Experimental

Polyps resection with bipolar electrode

干预措施: Bipolar Polypectomy (Procedure)

Bipolar electrode

Experimental

Polyps resection with bipolar electrode

干预措施: Bipolar electrode (Device)

Microscissors or graspers

Active Comparator

Polyps resection with microscissors or graspers

干预措施: Mechanical Polypectomy (Procedure)

Microscissors or graspers

Active Comparator

Polyps resection with microscissors or graspers

干预措施: Microscissors or graspers (Device)

结局指标

主要结局

To assess the tolerability of polypectomy using a validated visual analogue pain scale

时间窗: we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Angioni

Associate Professor

University of Cagliari

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