A Prospective Multicenter Registry of Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas.

Michael D Scheiber,Serena H Chen

doi:10.1089/gyn.2016.0008

Abstract

Background: Hysteroscopic morcellation removes uterine pathology under direct visualization with continuous real-time tissue fragment removal. Objective: The aim of this study was to explore the feasibility of hysteroscopic morcellation across a diverse set of facilities, including both surgical and office-based settings. Design: This was a prospective, single-arm, multicenter registry development (Canadian Task Force classification II-3). Materials and Methods: Thirty-four U.S. obstetrics and gynecology facilities enrolled subjects into the registry. Inclusion criteria were women ages 18–65 with indications for hysteroscopic myomectomy and/or polypectomy who were treated with the MyoSure® Hysteroscopic Tissue Removal System (Hologic Inc., Marlborough, MA). Intrauterine lesion type/size and removal parameters, adverse events (AEs), and physician satisfaction ratings were recorded. Results: A total of 559 pathologies (187 fibroids; 372 polyps) were removed from 278 registered subjects (mean age: 43.9 ± 9.0 years), with 250 procedures (89.9%) performed in an ambulatory surgery center or hospital outpatient setting and 28 (10.1%) in a gynecologic office setting. Most patients (n = 206, 74.1%) were treated for abnormal uterine bleeding, and 42 (15.1%) were treated for infertility. Mean fibroid diameter was 2.2 ± 1.2 cm. Mean polyp diameter was 1.3 ± 1.0 cm. Overall mean percentage of pathology removed was 95.4% (polyps 99.3%, fibroids 86.8%). Five AEs included four incidents of blunt cervical trauma and a single postoperative case of pedal edema; all were considered mild and resolved spontaneously. Postprocedure surveys indicated that 95% of reporting physicians were “satisfied” or “highly satisfied” with device performance. Conclusions: Hysteroscopic morcellation of intrauterine pathology was accomplished safely with a high degree of physician satisfaction in 278 patients treated in diverse healthcare settings that are reflective of general community practice in the United States. (J GYNECOL SURG 32:318)

Highlights

30%–50% of abnormal uterine bleeding (AUB) is caused by intracavitary polyps and submucous myomas.[1,2] There is compelling evidence that removing these growths provides excellent resolution of symptoms.[1,2,3] In addition to dilation and curettage and polyp forceps, operative hysteroscopy is among the most common minimally invasive surgical treatments for intrauterine polyp and myoma removal
Hysteroscopic morcellation of intrauterine pathology was accomplished safely with a high degree of physician satisfaction in 278 patients treated in diverse healthcare settings that are reflective of general community practice in the United States. ( J GYNECOL SURG 32:318)
The participating institutions were diverse with respect to both facility type (7 obstetrics/gynecology offices, 15 nonacademic hospitals/ASCs, academic hospitals/ ASCs) and U.S geographic location (5 Northeast, 7 Midwest, South, and 9 West)

Summary

Introduction

30%–50% of abnormal uterine bleeding (AUB) is caused by intracavitary polyps and submucous myomas.[1,2] There is compelling evidence that removing these growths provides excellent resolution of symptoms.[1,2,3] In addition to dilation and curettage and polyp forceps, operative hysteroscopy is among the most common minimally invasive surgical treatments for intrauterine polyp and myoma removal. A resectoscope equipped with a radiofrequency-activated cutting loop or an electrical bipolar loop is used to remove intrauterine pathology.[4,5,6] Tissue fragments resected from either the polyp or fibroid remain in the distended uterus until manually removed with graspers. Results: A total of 559 pathologies (187 fibroids; 372 polyps) were removed from 278 registered subjects (mean age: 43.9 – 9.0 years), with 250 procedures (89.9%) performed in an ambulatory surgery center or hospital outpatient setting and 28 (10.1%) in a gynecologic office setting. Conclusions: Hysteroscopic morcellation of intrauterine pathology was accomplished safely with a high degree of physician satisfaction in 278 patients treated in diverse healthcare settings that are reflective of general community practice in the United States. Conclusions: Hysteroscopic morcellation of intrauterine pathology was accomplished safely with a high degree of physician satisfaction in 278 patients treated in diverse healthcare settings that are reflective of general community practice in the United States. ( J GYNECOL SURG 32:318)

Objectives

Methods

Results