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In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial.
Fertil Steril. 2016 May; 105(5):1369-1376.FS

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.

Authors+Show Affiliations

Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy. Electronic address: morenarocca@hotmail.it.Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.Department of Woman and Child Health, University of Padua, Padua, Italy.Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.Department of Biomedicine and Prevention, "Tor Vergata" University of Rome, Rome, Italy.Unit of Obstetrics and Gynaecology, Department of Experimental and Clinical Medicine, "Magna Graecia" University, Catanzaro, Italy.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26801067

Citation

Venturella, Roberta, et al. "In-bag Manual Versus Uncontained Power Morcellation for Laparoscopic Myomectomy: Randomized Controlled Trial." Fertility and Sterility, vol. 105, no. 5, 2016, pp. 1369-1376.
Venturella R, Rocca ML, Lico D, et al. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016;105(5):1369-1376.
Venturella, R., Rocca, M. L., Lico, D., La Ferrera, N., Cirillo, R., Gizzo, S., Morelli, M., Zupi, E., & Zullo, F. (2016). In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertility and Sterility, 105(5), 1369-1376. https://doi.org/10.1016/j.fertnstert.2015.12.133
Venturella R, et al. In-bag Manual Versus Uncontained Power Morcellation for Laparoscopic Myomectomy: Randomized Controlled Trial. Fertil Steril. 2016;105(5):1369-1376. PubMed PMID: 26801067.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. AU - Venturella,Roberta, AU - Rocca,Morena L, AU - Lico,Daniela, AU - La Ferrera,Nicolò, AU - Cirillo,Roberto, AU - Gizzo,Salvatore, AU - Morelli,Michele, AU - Zupi,Errico, AU - Zullo,Fulvio, Y1 - 2016/01/19/ PY - 2015/10/26/received PY - 2015/12/10/revised PY - 2015/12/21/accepted PY - 2016/1/24/entrez PY - 2016/1/24/pubmed PY - 2017/5/24/medline KW - Fibroid KW - in-bag morcellation KW - myomectomy KW - power morcellation KW - sarcoma SP - 1369 EP - 1376 JF - Fertility and sterility JO - Fertil. Steril. VL - 105 IS - 5 N2 - 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. SN - 1556-5653 UR - https://www.unboundmedicine.com/medline/citation/26801067/In_bag_manual_versus_uncontained_power_morcellation_for_laparoscopic_myomectomy:_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015-0282(15)02313-4 DB - PRIME DP - Unbound Medicine ER -