Comparison of Tissue Adequacy from Office-based Endometrial Sampling between Manual Vacuum Aspiration and the Wallach Endocell in Premenopausal and Perimenopausal Women with Abnormal Uterine Bleeding: A randomized controlled trial

Abstract

Objectives: To investigate the tissue adequacy rate of endometrial biopsy devices (Wallach Endocell® and manual vacuum aspiration [MVA]), focusing on premenopausal and perimenopausal women, in an outpatient setting.
Materials and Methods: In this randomized controlled trial, 290 premenopausal or perimenopausal women with abnormal uterine bleeding who planned to undergo an endometrial biopsy were randomized to Ipas MVA Plus® (n = 146) and Wallach Endocell® (n = 144). The primary outcome was tissue adequacy for pathological examination, which was evaluated by two pathologists. Secondary outcomes were the amount of endometrial tissue, postoperative pain scores, immediate complications of the procedure, patient satisfaction, and operator satisfaction.
Results: The mean and standard deviation of participants’ age were 42.8 ± 5.9 and 43.6 ± 5.8 years in the MVA and Endocell groups, respectively. Tissue adequacy for pathological examination in the MVA and Endocell groups was 95.2% and 95.8%, respectively. Both methods did not show differences in tissue adequacy (p = 1.00). The median amount of endometrial tissue was slightly higher in the MVA group than in the Endocell group (2.1 g vs 1.8 g, p = 0.02). The pain score during the procedure was slightly higher in the MVA group than in the Endocell group (p < 0.01). Patient satisfaction and operator satisfaction did not differ between groups. The complications that we found were pelvic pain and pelvic infection, which did not differ between groups (1.4% vs 2.8%, p = 0.4).
Conclusion: There was no evidence that the efficacy of endometrial tissue biopsy by MVA or Endocell was different in terms of tissue adequacy for pathological diagnosis. Both devices showed a very high percentage of tissue adequacy and very low adverse effects.