Improving Outpatient Endometrial Biopsy Results

ConditionsHistopathology Screening Tool Techniques

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorCairo University

About this trial

Pipelle is the most commonly used outpatient endometrial biopsy device. Pipelle endometrial biopsy can diagnose 90% of endometrial cancer cases. Pipelle endometrial biopsy is one of the first-line diagnostic procedures for women presenting with abnormal peri- and post-menopausal vaginal bleeding.

Insufficient samples are obtained in 5-23% of cases. In Adan Hospital, a retrospective analysis of all outpatient endometrial samples sent to the histopathology department from April- to October 2024 study showed an insufficient sample percentage of 32% This may be attributed to factors such as patients, equipment, and physicians.

This project aims to improve the endometrial biopsy results by Identifying these factors in the Adan hospital setting, Implementing measures to modify these factors, and finally re-auditing the endometrial biopsy results after six months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients undergoing outpatient endometrial biopsy in the specified time interval (11/2024- 4/2025) will be included.

Disqualifiers

Could not obtain the sample due to patient physicals, anxiety (patient decline), cervical stenosis, or severe bleeding

Trial population

All patients undergoing outpatient endometrial sampling

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Improving technique
Other intervention
A checklist was developed to ensure the important steps were followed, with tips for obtaining a more adequate sample. This checklist was put in the outpatient procedures room, and each physician performing a biopsy was asked to fill it out. Also, a diagram containing illustrative images with the basic steps was put in the procedures room. The topic was covered in the biweekly scientific meeting, and all factors attributed to the inadequate sample were discussed. The department lead mentioned the topic in the OBGYN department's private messaging group. It was finally mentioned in the morning meeting.
Using hysteroscopy in candidate patients
Other intervention
Patients with focal lesions on ultrasound will undergo hysteroscopy and biopsy instead of blind endometrial sampling. Patient with stenosed cervix or failed previous sampling might also undergo hysteroscopic guided biopsy.
Analgesia
Other intervention
Analgesia in the form of paracetamol or NSAIDs might be given to some patients 30- 60 minutes before the procedure to reduce the procedure-associated pain and the resultant failure to complete it and obtain an adequate sample.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Adequacy of the sampled endometrial specimen for histopathology diagnosis

Time frame

six months

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Adan hospitalRecruiting47000, Kuwait, Al Ahmadi Kuwait

Kuwait

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Al Adan Hospital Kuwait

Collaborator

Source ClinicalTrials.gov

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