ABSTRACT
BACKGROUND: Endometrial biopsy has been reported to sample only a small percentage of the endometrial tissue with a lower sensitivity for focal and pedunculated lesions. It has been suggested that failure to diagnose intracavity lesions could be reduced or even eliminated by complementing endometrial sampling with outpatient hysteroscopy. The authors of this study assessed whether adding hysteroscopy to the evaluation routinely would offer clinical benefit.
POPULATION STUDIED: Ten consulting gynecologists recruited 370 premenopausal women who were referred to an outpatient gynecology clinic for abnormal uterine bleeding during a 3-year period. The women were eligible if they had a uterine size of 12 weeks or less by bimanual examination and if the attending gynecologist determined that endometrial sampling was required for diagnostic purposes.
STUDY DESIGN AND VALIDITY: In this randomized controlled trial, neither patients nor physicians were blinded to treatment group. It is not clear whether blinded evaluators performed some outcome assessments. Women randomized to endometrial biopsy underwent the procedure during their initial clinic visit using a 3-mm Pipelle biopsy kit in standard fashion.
OUTCOMES MEASURED: The primary outcome was surgical intervention rate, as determined by chart review. Secondary outcomes included procedural success and acceptability, intrauterine pathology identified, and clinical management.
RESULTS: No difference was noted in hysterectomy or endometrial ablation rates between the 2 groups. Procedural acceptability was no different across 11 of 12 parameters, with the only reported significant difference being that women undergoing hysteroscopy were “happier” than patients undergoing just endometrial biopsy. Reported pain levels as measured by the McGill Pain Questionnaire were no different for the two procedures and only slightly greater than the pain estimated for a Pap smear or vaginal examination.
This study was useful in demonstrating that hysteroscopy is acceptable to patients and no more painful than endometrial biopsy. However, routine hysteroscopy does not change the rate of surgical intervention required by premenopausal women with abnormal uterine bleeding.