Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Visual Analog Scala for patient's pain perception
研究概览
简要总结
Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a single tooth tenaculum to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. However, grasping the cervix with a tenaculum can be a painful experience for the patient.A randomized controlled trial was conducted to evaluate using of tenaculum on pain perception of the patients and the procedure performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.
详细描述
One hundred fifteen patients included for assessing pain perception and procedure performance during endometrial with pipelle. Patients were randomly assigned to one of two groups as Group 1( with tenaculum) and Group 2 (without tenaculum).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •The women has required endometrial sampling procedure in gynecology outpatients clinic.
- •Who are capable understand the spoken words and describe the pain.
排除标准
- •Stenotic cervical canal
- •They had acute cervicitis
- •Intense anxiety
- •Need for coincident endocervical curettage
- •Need for general anesthesia or local anesthetics
- •The use of analgesic drug pre-procedure
- •Known history of malignancy
- •Uterine anomalies or leiomyomas that distort the cervical canal and cavity
- •A history of failed office endometrial sampling
- •Positive β-HCG test.
研究组 & 干预措施
Group 1(With Tenaculum)
This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure
干预措施: Tenaculum (Device)
Group 2 (Without Tenaculum)
This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure.
结局指标
主要结局
Visual Analog Scala for patient's pain perception
时间窗: 5 second
VAS performed four times each patient.
次要结局
- Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis.(5-10 day)
- Likert scala for procedure performance(5 second)
研究者
Ümran Küçükgöz Güleç
Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
Cukurova University