Hysteroscopic Morcellation Versus Loop Resection for Removal of Placental Remnants: A Randomized Trial.

STUDY OBJECTIVE: To compare hysteroscopic morcellation with loop resection for the removal of placental remnants in terms of procedure time, adverse events, tissue availability, histology results, short-term effectiveness, and postoperative adhesions. DESIGN: A randomized controlled trial (Canadian Task Force classification I). SETTING: A teaching and university hospital. PATIENTS: Women with placental remnants. INTERVENTIONS: Hysteroscopic morcellation with the TRUCLEAR 8.0 Tissue Removal System (Smith & Nephew, Inc, Andover, MA) or loop resection with a rigid 8.5-mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany). MEASUREMENTS AND MAIN RESULTS: Forty-six and 40 women were included in the hysteroscopic morcellation and resection groups, respectively. The median operating time was significantly shorter for hysteroscopic morcellation compared with loop resection (6.2 minutes [interquartile range, 4.0-11.2 minutes] vs 10.0 minutes [5.8-16.4 minutes], p = .023). Both operating time and total procedure time, corrected for the diameter of the placental remnants, were significantly reduced for hysteroscopic morcellation compared with loop resection, by 40% (95% confidence interval, 15%-58%; p = .005) and 22% (95% CI, 5%-37%; p = .014), respectively. No adverse events occurred during hysteroscopic removal. Perforation at dilation in 8 cases of the hysteroscopic morcellation group resulted in 2 procedure discontinuations and 1 incomplete procedure. Incomplete removal was found in 1 uncomplicated hysteroscopic morcellation procedure and 2 resection procedures. Pathology results confirmed the presence of placental remnants in 27 of 40 (67.5%) and 26 of 37 (70%) patients in the hysteroscopic morcellation and resection groups, respectively. Second-look hysteroscopy showed de novo intrauterine adhesions in 1 of 35 patients (3%) in the hysteroscopic morcellation group and 1 of 30 (3%) patients in the resection group. CONCLUSION: Hysteroscopic morcellation is a faster alternative than loop resection. Both techniques are safe and show high rates of complete removal and tissue availability and low rates of de novo intrauterine adhesions.

Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial.

BACKGROUND: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities. METHOD/DESIGN: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate. DISCUSSON: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding. TRIAL REGISTRATION: Dutch trial register, number NTR2984.