A prospective, randomized comparison of the Pipelle endometrial sampling device with the Novak curette.

This prospective, randomized study compares sample adequacy, pain associated with endometrial biopsy, and correlation of endometrial histologic sampling with hysterectomy histologic results in specimens obtained by the Pipelle (Unimar Inc., Wilton, Conn.) device (N = 149) and the Novak (Miltex, Inc., Lake Success, N.Y.) curette (N = 126). During a 2-year period, patients with abnormal uterine bleeding seen in our ambulatory care facility were enrolled in this trial, unless they did not wish to participate or had a positive pregnancy test result. Patients in both groups were similar with respect to mean gravidity, parity, and menopausal status, although patients in the Novak group were older (43.4 vs 39.1 years, p = 0.005). Patients undergoing Novak biopsy had a mean pain score of 4.36 with 22 of 126 (17%) reporting severe pain, whereas patients undergoing Pipelle biopsy had a mean pain score of 3.21 with only 10 of 149 (6.7%) reporting severe pain (p less than 0.05). These pain scores were not affected by menstrual day, gravidity, parity, or menopausal status. Insufficient tissue was reported in 12.8% of patients in the Pipelle group compared with 9.5% in the Novak group (p greater than 0.05). Fifty patients underwent subsequent hysterectomy. In 48 of 50 (96%), the pathologic results at hysterectomy were in agreement with the histologic findings at endometrial sampling. This clinical trial suggests that Pipelle biopsy appears to be as effective as the Novak curette in obtaining an adequate specimen for histologic analysis and is associated with less pain.

RCT Entities:   Population Interventions Outcomes