Abnormal Uterine Bleeding, Postmenopausal Bleeding
Conditions
Keywords
Endometrial Biopsy, Pipelle, Karman Cannula, Paracervical Block, Abnormal Uterine Bleeding, Postmenopausal Bleeding, Diagnostic Adequacy, Patient Satisfaction
Brief summary
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.
Detailed description
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. Standardized analgesia and inclusion of clinical, patient-centered, and economic outcomes are intended to provide practical evidence to guide the selection of endometrial biopsy methods in routine gynecologic practice.
Interventions
DEVICEPipelle Endometrial Biopsy
Endometrial sampling performed using a Pipelle device in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants.
DEVICEKarman Cannula Endometrial Biopsy
Endometrial sampling performed using a Karman cannula in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants.
Sponsors
Gaziosmanpasa Research and Education Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Histopathological evaluation of endometrial samples is performed by pathologists who are blinded to the biopsy method used.
Intervention model description
Eligible participants are randomly assigned in a 1:1 ratio to undergo endometrial biopsy using either the Pipelle device or the Karman cannula, with both groups treated concurrently.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Adequate Endometrial Sample Rate | At the index procedure (same day) | Proportion of endometrial biopsy samples considered clinically adequate for diagnosis based on blinded histopathological assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-Related Pain Score | Periprocedural | Eligible participants undergo outpatient endometrial sampling under a standardized analgesia protocol: 3 mL of 2% prilocaine is injected for a paracervical block at the 1 and 11 o'clock positions before tenaculum application, followed by a 2-minute waiting period; a tenaculum is then applied and endometrial sampling is performed using either a Pipelle device or a 5-mm Karman cannula according to random assignment. Sampling is recorded as the number of predefined sampling cycles (maximum 3), and cervical stenosis, need for dilation, procedure duration, additional analgesia (e.g., NSAIDs), and complications are documented. Specimens are placed immediately in formalin in identical containers labeled with study ID only, sent daily in mixed order, and evaluated by pathologists blinded to sampling method for adequacy and diagnosis (including reason for inadequacy). Pain is assessed using the Visual Analog Scale for Pain (0-10; higher scores indicate worse pain) during the procedure and at 3 |
| Patient Satisfaction With the Procedure | Same day after the procedure | Patient-reported satisfaction with the endometrial biopsy procedure assessed using a Likert-type questionnaire, including willingness to undergo the same procedure again if needed. |
| Procedure Duration | During the procedure | Time required to complete the endometrial biopsy procedure, measured from speculum insertion to completion of tissue sampling. |
| Need for Additional Diagnostic Procedures | Within 2 weeks after the procedure | Proportion of participants requiring additional diagnostic procedures due to an inadequate endometrial biopsy sample. |
| Hospital-Related Cost per Participant | Within 2 weeks after the procedure | Total hospital-related cost per participant, including procedural costs and costs related to additional diagnostic interventions when required. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORFatma Ketenci Gencer, Assoc. Prof.
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
Outcome results
None listed