title: In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial.
abstract: OBJECTIVE
  To evaluate whether manualin-bag morcellation could be efficiently proposed as alternative to the uncontained power technique.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Academic hospital.
  
  
  METHODS
  One hundred fifty-two premenopausal women eligible for myomectomy were screened, and 104 were randomized.
  
  
  METHODS
  Patients were randomized into two groups. In the experimental group, "in-bag" protected morcellation was performed. In the control group, patients were treated by uncontained power myoma removal.
  
  
  METHODS
  The primary endpoint was the comparison of morcellation operative time (MOT). The secondary endpoints were the comparisons of total operative time (TOT), simplicity of morcellation (as defined by the surgeon using a visual analogue scale scale), intraoperative blood loss, rate of complications, and postoperative outcomes.
  
  
  RESULTS
  A sample size of 51 per group (n = 102) was planned. Between March 2014 and January 2015, patients were randomized as follows: 53 to the experimental group and 51 to the control group. Most demographic characteristics were similar across groups. MOT was observed to be similar in both study groups (16.18 ± 8.1 vs. 14.35 ± 7.8 minutes, in the experimental and control groups, respectively). Fibroid size was identified as the principal factor influencing morcellation time (Pearson coefficient 0.484 vs. 0.581, in the experimental and control groups, respectively). No significant difference in TOT, simplicity of morcellation, delta Hb, postoperative pain, and postoperative outcomes were observed between groups.
  
  
  CONCLUSIONS
  The protected manual in-bag morcellation technique represents a time-efficient and feasible alternative, which does not interfere with surgical outcomes in women undergoing laparoscopic myomectomy.
  
  
  BACKGROUND
  NCT02086435.
authors.affiliation: Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Venturella
authors.affiliation: Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy. Electronic address: morenarocca@hotmail.it.
authors.forename: Morena L
authors.initials: ML
authors.lastname: Rocca
authors.affiliation: Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Lico
authors.affiliation: Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.
authors.forename: Nicolò
authors.initials: N
authors.lastname: La Ferrera
authors.affiliation: Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Cirillo
authors.affiliation: Department of Woman and Child Health, University of Padua, Padua, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Gizzo
authors.affiliation: Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Morelli
authors.affiliation: Department of Biomedicine and Prevention, "Tor Vergata" University of Rome, Rome, Italy.
authors.forename: Errico
authors.initials: E
authors.lastname: Zupi
authors.affiliation: Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Zullo
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000295:instrumentation / Q000379:methods*; D007889:Leiomyoma / Q000473:pathology / Q000601:surgery*; D000069577:Morcellation / Q000295:instrumentation / Q000379:methods*; D011446:Prospective Studies; D063186:Uterine Myomectomy / Q000295:instrumentation / Q000379:methods*
keywords: Fibroid; in-bag morcellation; myomectomy; power morcellation; sarcoma