Is outpatient diagnostic hysteroscopy more useful than endometrial biopsy alone for the investigation of abnormal uterine bleeding in unselected premenopausal women? A randomised comparison

Objective To formally evaluate the clinical benefit of additional outpatient hysteroscopy over traditional vaginal examination and endometrial biopsy.

Design A prospective randomised controlled trial.

Setting A large teaching hospital in the northeast of Scotland.

Sample Premenopausal women with abnormal uterine bleeding referred to the general gynaecologic clinic and requiring endometrial biopsy.

Methods Women were randomised to either outpatient hysteroscopy and endometrial biopsy or endometrial biopsy alone.

Main outcome measures Primary outcome: initial surgical intervention rates. Secondary outcomes: procedural success and acceptability, intrauterine pathology identified and changes in management.

Results Three hundred and seventy women were recruited to the study. Initial trends in clinical management were comparable in both groups. No woman was advised to have removal of a localised lesion found at outpatient hysteroscopy and a normal uterine cavity at hysteroscopy did not influence the hysterectomy rate, which was similar in both groups. Outpatient hysteroscopy was found to be as acceptable as an outpatient endometrial biopsy and successfully completed in 85% compared with 91% of women who underwent endometrial biopsy alone. No cases of endometrial malignancy were identified.

Conclusions Outpatient diagnostic hysteroscopy is an acceptable procedure and may give more reassurance. It did not influence clinical management, especially with respect to hysterectomy rate. Outpatient hysteroscopy may be useful in selected cases, but when performed in a non-selective manner, it has little influence on clinical management and increases costs.