Endometrial sampling technique using pipelle sampler Not Applicable
Conditions
Interventions
Patients who are indicated for pipelle sampling will be randomised to performing pipelle without intervention or pipelle with a full bladder.
Patients randomised to full bladder group will be given
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. All women with abnormal uterine bleeding indicated for pipelle sampling 2. Age =18 years old
Exclusion criteria
Exclusion criteria: 1. A known stenotic cervical os 2. Having acute cervicitis 3. Intense anxiety 4. Had been diagnosed with bladder dysfunction 5. Needed general anaesthesia or local anaesthetics 6. Used analgesic drugs before the pre-procedure 7. Known history of malignancy, uterine anomalies, or leiomyoma distorts the cervical canal or uterine cavity 8. Had a history of failed office endometrial sampling procedure 9. Currently with a positive b-HCG test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure rate of performing pipelle sampling at first attempt without cervical manipulation (failure to perform a pipelle sampling is defined when the depth of the pipelle inserted is less than 4 cm) measured using patient records at the time of procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain assessed using an 11-point visual numerical rating scale score from 0-10 (high score, greater pain) during the procedure 2. Patient satisfaction assessed by asking 'Please rate the satisfaction with regards to the procedure you had' using an 11-point visual numerical rating scale score from 0-10 (high score, greater satisfaction) immediately after the procedure is completed 3. Analgesia use post-procedure measured by reviewing patient notes immediately after the procedure 4. Duration to complete procedure, defined as the time from speculum inserted into the vagina to speculum removed during the procedure 5. The bladder's volume measured using ultrasound performed 1 hour after drinking 1 litre of fluid or when the patient has the sensation to urinate 6. Sensation to urinate assessed by asking, 'Do you have the sensation to urinate now?' to bladder volume calculated by ultrasound during ultrasound assessment 7. The need for additional manoeuvres during the procedure (cervical manipulation) measured using patient notes 8. Failure rate after the manoeuvre, defined as when the depth of pipelle inserted is less than 4 cm, or when the patient requested for the procedure to be stopped measured using patient notes 9. Complications developed during the procedure, mainly cervical trauma or syncopal attack following a vaso-vagal attack measured using patient notes if analgesia use immediately after the procedure | — |
Countries
Malaysia
Outcome results
None listed