Abnormal Uterine Bleeding
Conditions
Keywords
Menorrhagia, Uterine fibroids, Endometrial polyps, Endometrial cancer
Brief summary
The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.
Detailed description
We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.
Interventions
PROCEDUREEndometrial biopsy
Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
Sponsors
Royal Free Hampstead NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Indication to carry out diagnostic hysteroscopy * Agrees and is suitable for outpatient/office hysteroscopy
Exclusion criteria
* Failed outpatient/office hysteroscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discomfort | End of procedure |
Secondary
| Measure | Time frame |
|---|---|
| Procedure time, biopsy adequacy | End of procedure |
Countries
United Kingdom
Outcome results
None listed