In bag manual versus uncontained power morcellation for laparoscopic myomectomy Randomized controlled trial

Capsule:
Protected manual in-bag morcellation may be considered efficient and feasible in that it does not interfere with surgical outcomes in women undergoing laparoscopic myomectomy.

Authors:
Roberta Venturella, M.D., Morena L. Rocca, M.D., Daniela Lico, M.D., Nicolò La Ferrera, M.D., Roberto Cirillo, M.D., Salvatore Gizzo, M.D., Michele Morelli, M.D., Ph.D., Errico Zupi, M.D., Fulvio Zullo, M.D., Ph.D.

Volume 105, Issue 5, Pages 1369-1376

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:
ClinicalTrials.gov, www.clinicaltrials.gov, NCT02086435.

  • Shvetha Zarek

    This RCT is well designed and provides important information about morcellation surgical techniques in light of the FDA’s 2014 statement regarding the use of power morcellation. Subsequent studies demonstrate careful pre-operative selection of patients is important and higher risk of uterine sarcoma is seen in patients age 50 years and older. This study excluded patients above the age of 40 years. Given the results of the in-bag morcellation, would the authors consider in-bag morcellation for patients above 40 years? Thank you for an excellent article.

Translate »