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临床试验/NCT00786461
NCT00786461Unknown4 期

The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate

University of Aarhus2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
4 期
入组人数
30
试验地点
2
主要终点
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment

研究概览

简要总结

Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization treatment.

It is expected that silver nitrate treatment is effective, simple, inexpensive and the least anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.

详细描述

Background and objective:

Bartholin gland cysts and abscesses are common problems in women of reproductive age. The traditional treatment of Bartholin´s cyst or abscess is marsupialization, which has disadvantages, such as pain of long duration, scarring, risk of general anaesthesia and risk of recurrence. In the present study we use silver nitrate in the treatment of Bartholin's cyst or abscess and compare to marsupialization. We expect lower healing time, lower recurrence rate and less pain with the silver nitrate treatment.

Methods and materials:

30 patients with Bartholin´s cyst or abscess will be investigated. It is prospective randomized study. The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.

The standard marsupialization treatment is performed under general anaesthesia.

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

入选标准

  • Women with a age of 18-60 years
  • Should read and understand Danish
  • All women inclusive pregnant should have a Bartholins cyst or abscess

排除标准

  • Subject who cannot give written informed consent

结局指标

主要结局

Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment

时间窗: up to one year after treatment

次要结局

  • Wound healing, local burning, sequelae, hospitalisation time(3-4 weeks after treatment)

研究者

申办方类型
Other

研究点 (2)

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