Comparison of Pipelle and Karman Endometrial Biopsy Methods Under Standardized Paracervical Block: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Clinically Adequate Endometrial Sample Rate
研究概览
简要总结
Endometrial biopsy is a commonly used outpatient procedure to evaluate abnormal uterine bleeding and postmenopausal bleeding. Different sampling methods are available, but their diagnostic adequacy and patient experience may vary.
This prospective randomized study compares two commonly used endometrial biopsy methods, Pipelle and Karman cannula, under standardized paracervical block anesthesia. All participants receive the same local anesthetic technique to minimize pain-related differences between methods.
The primary objective is to compare the rate of clinically adequate endometrial samples obtained with each method. Secondary outcomes include patient-reported pain, patient satisfaction, procedure duration, need for additional diagnostic procedures, and hospital-related costs.
Study findings are expected to support clinical decision-making regarding the most effective and practical endometrial biopsy method when adequate pain control is provided.
详细描述
Endometrial biopsy is an essential diagnostic procedure in the evaluation of abnormal uterine bleeding and postmenopausal bleeding. Office-based endometrial sampling techniques are widely used because these techniques are minimally invasive and cost-effective; however, diagnostic adequacy, patient tolerance, and resource utilization may differ between methods.
Pain during the procedure is a major factor affecting patient experience and may confound comparisons between sampling techniques. To address this limitation, participants receive a standardized paracervical block using the same anesthetic agent, dose, and technique, allowing the comparison to focus on the intrinsic performance of the biopsy methods rather than differences in analgesia.
This is a prospective, randomized, parallel-group study. Eligible participants undergoing endometrial biopsy are randomly assigned in a 1:1 ratio to either Pipelle endometrial biopsy or Karman cannula endometrial sampling. Randomization is stratified by menopausal status. Procedures are performed in an outpatient setting according to routine clinical practice.
Histopathological evaluation of endometrial samples is performed by pathologists blinded to the sampling method. Sample adequacy is assessed based on predefined criteria, with a focus on whether the specimen provides sufficient information for clinical decision-making.
In addition to diagnostic adequacy, patient-reported outcomes, including pain and satisfaction with the procedure, are assessed. Procedure duration, need for additional diagnostic interventions due to inadequate sampling, and hospital-related costs associated with each method are also evaluated.
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 (Outcomes Assessor)
盲法说明
Histopathological evaluation of endometrial samples is performed by pathologists who are blinded to the biopsy method used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 years or older
- •Abnormal uterine bleeding or postmenopausal bleeding requiring endometrial sampling
- •Ability to provide written informed consent
- •Eligible for office-based endometrial biopsy
排除标准
- •Pregnancy
- •Active pelvic infection
- •Known cervical or endometrial cancer
- •Severe cervical stenosis preventing endometrial sampling
- •Known bleeding disorders or use of anticoagulant therapy that contraindicates biopsy
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
Pipelle Endometrial Biopsy
Participants assigned to this arm undergo office-based endometrial biopsy using a Pipelle device. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm.
干预措施: Pipelle Endometrial Biopsy (Device)
Karman Endometrial Biopsy
Participants assigned to this arm undergo office-based endometrial sampling using a Karman cannula. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm.
干预措施: Karman Cannula Endometrial Biopsy (Device)
结局指标
主要结局
Clinically Adequate Endometrial Sample Rate
时间窗: At the index procedure (same day)
Proportion of endometrial biopsy samples considered clinically adequate for diagnosis based on blinded histopathological assessment.
次要结局
- Procedure-Related Pain Score(Periprocedural)
- Patient Satisfaction With the Procedure(Same day after the procedure)
- Procedure Duration(During the procedure)
- Need for Additional Diagnostic Procedures(Within 2 weeks after the procedure)
- Hospital-Related Cost per Participant(Within 2 weeks after the procedure)
研究者
Havva Betül Bacak
Principal Investigator
Gaziosmanpasa Research and Education Hospital