Preclinical safety testing and initial experience of a morcellation bag with four sealable ports

Michael Anapolski,Sven Schiermeier,Alexander Gut,Stefan Soltesz,Ibrahim Alkatout,Thomas Papathemelis,Dimitrios Panayotopoulos,Günter K Noé,Anja Schellenberger

doi:10.1038/s41598-021-99934-1

Abstract

Electromechanical morcellation—so called power morcellation—is a minimally invasive approach to remove bulky lesions such as uterine fibroids. The spread of benign and malignant tissue due to morcellation is a major concern that might limit the use of laparoscopic interventions. We present an in vitro evaluation of the safety characteristics of a four-port endobag with closable trocar sleeves, and describe physical properties of the bag that may or may not allow passage through the hole. In addition, we report our preliminary experience of this tool when used for laparoscopic supracervical hysterectomies. The behavior of the endobag during the extraction process was analyzed by extracting opened and re-sealed bags filled with 20 ml blue dye solution through a wooden template, with incisions measuring 10 to 24 mm. The endobag was used in 50 subtotal hysterectomies during the morcellation procedure. In the in vitro test, no dye loss was recorded for incisions measuring 11–24 mm. The mean force required to pull the bag through the template was inversely proportional to incision size. No bag rupture occurred during the surgical procedures. The mean time taken to prepare the bag for morcellation was 7.1 min (range, 4–14 min), the mean duration of subtotal hysterectomy was 53.4 min (range, 20–194 min). The mean weight of the removed body of the uterus was 113.8 g (range, 13–896 g), the mean weight of tissue and fluid remaining in the bag after morcellation 7.9 g (range, 0–39 g). In the in vitro setting, the improved endobag signifies greater patient safety during bag extraction, along with less tissue traumatization due to a smaller incision in the abdominal wall. The improved ergonomic features of the bag permit the insertion of three trocars in the lower abdomen and avoid closure of unused access ports. Our preliminary experience has shown that the device can be used under routine conditions. Failure rates will be evaluated in future studies.

Highlights

Electromechanical morcellation—so called power morcellation—is a minimally invasive approach to remove bulky lesions such as uterine fibroids
In most modern operating rooms, electromechanical or so-called power morcellation involves the use of a round rotating blade that permits the extraction of tissue fragments without performing a laparotomy
Three types of complications or difficulties have been associated with the use of power morcellation: the risk of organ injury, difficulties in the identification of histopathological tissue patterns, and the risk of benign or malignant tissue spread in the abdomen

Summary

Introduction

Electromechanical morcellation—so called power morcellation—is a minimally invasive approach to remove bulky lesions such as uterine fibroids. In the in vitro setting, the improved endobag signifies greater patient safety during bag extraction, along with less tissue traumatization due to a smaller incision in the abdominal wall. Three types of complications or difficulties have been associated with the use of power morcellation: the risk of organ injury, difficulties in the identification of histopathological tissue patterns, and the risk of benign or malignant tissue spread in the abdomen. Minor and major complications, such as injury to abdominal organs have been described in the published literature as well as in complication databases[3,4] These events must be taken into account, their overall risk in relation to the total number of morcellations carried out so far is low. As far as the histopathological evaluation of tissue is concerned, the introduction of power morcellation necessitated the adjustment of clinical routine for the assessment of small tissue fragments[5]

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