PMID- 27965523
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 1042-4067 (Print)
IS  - 1557-7724 (Electronic)
IS  - 1042-4067 (Linking)
VI  - 32
IP  - 6
DP  - 2016 Dec 1
TI  - A Prospective Multicenter Registry of Patients Undergoing Hysteroscopic 
      Morcellation of Uterine Polyps and Myomas.
PG  - 318-323
AB  - 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(R) 
      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).
FAU - Scheiber, Michael D
AU  - Scheiber MD
AD  - Institute for Reproductive Health , Cincinnati, OH.
FAU - Chen, Serena H
AU  - Chen SH
AD  - Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center 
      , Livingston, NJ.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Gynecol Surg
JT  - Journal of gynecologic surgery
JID - 9000936
PMC - PMC5144868
OTO - NOTNLM
OT  - endometrial polyp
OT  - hysteroscopic morcellator
OT  - intrauterine morcellation
OT  - submucous myoma
COIS- Author Disclosure Statement M.D.S. and S.H.C. received compensation for speaking 
      engagements by Hologic Inc. Neither author has any other potential conflicts of 
      interest to report, financial or otherwise.
EDAT- 2016/12/15 06:00
MHDA- 2016/12/15 06:01
PMCR- 2016/12/01
CRDT- 2016/12/15 06:00
PHST- 2016/12/15 06:00 [entrez]
PHST- 2016/12/15 06:00 [pubmed]
PHST- 2016/12/15 06:01 [medline]
PHST- 2016/12/01 00:00 [pmc-release]
AID - 10.1089/gyn.2016.0008 [pii]
AID - 10.1089/gyn.2016.0008 [doi]
PST - ppublish
SO  - J Gynecol Surg. 2016 Dec 1;32(6):318-323. doi: 10.1089/gyn.2016.0008.