Roberta Venturella1, Morena L Rocca2, Daniela Lico1, Nicolò La Ferrera1, Roberto Cirillo1, Salvatore Gizzo3, Michele Morelli1, Errico Zupi4, Fulvio Zullo1. 1. Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy. 2. Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy. Electronic address: morenarocca@hotmail.it. 3. Department of Woman and Child Health, University of Padua, Padua, Italy. 4. Department of Biomedicine and Prevention, "Tor Vergata" University of Rome, Rome, Italy.
Abstract
OBJECTIVE: To evaluate whether manualin-bag morcellation could be efficiently proposed as alternative to the uncontained power technique. DESIGN: Randomized controlled trial. SETTING: Academic hospital. PATIENT(S): One hundred fifty-two premenopausal women eligible for myomectomy were screened, and 104 were randomized. INTERVENTION(S): 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. MAIN OUTCOME MEASURE(S): 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. RESULT(S): 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. CONCLUSION(S): 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. CLINICAL TRIAL REGISTRATION: NCT02086435.
RCT Entities:
OBJECTIVE: To evaluate whether manualin-bag morcellation could be efficiently proposed as alternative to the uncontained power technique. DESIGN: Randomized controlled trial. SETTING: Academic hospital. PATIENT(S): One hundred fifty-two premenopausal women eligible for myomectomy were screened, and 104 were randomized. INTERVENTION(S): 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. MAIN OUTCOME MEASURE(S): 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. RESULT(S): 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. CONCLUSION(S): 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. CLINICAL TRIAL REGISTRATION: NCT02086435.
Authors: Dominik Denschlag; Sven Ackermann; Marco Johannes Battista; Wolfgang Cremer; Gerlinde Egerer; Markus Follmann; Heidemarie Haas; Philipp Harter; Simone Hettmer; Lars-Christian Horn; Ingolf Juhasz-Boess; Karin Kast; Günter Köhler; Thomas Kröncke; Katja Lindel; Peter Mallmann; Regine Meyer-Steinacker; Alexander Mustea; Edgar Petru; Peter Reichardt; Dietmar Schmidt; Hans-Georg Strauss; Clemens Tempfer; Falk Thiel; Uwe Ulrich; Thomas Vogl; Dirk Vordermark; Paul Gass; Matthias W Beckmann Journal: Geburtshilfe Frauenheilkd Date: 2019-10-22 Impact factor: 2.915
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