Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT02777203
Brief Summary:
The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation.
The hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.
Detailed Description:
Uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy menstrual bleeding, pain, and pressure. Common surgical treatment modalities are hysterectomy (removal of the uterus) or myomectomy (removal of the fibroid). Minimally invasive surgical techniques (laparoscopy) are generally recommended due to improved recovery time, decrease infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks.
In order to remove a large uterus or large fibroids laparoscopically, a power morcellator is often used to cut the specimen into smaller pieces that can be removed through small incisions. Due to the concern regarding spread of small amounts of tissue during power morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation inside a specimen bag.
This study will be evaluating the efficacy of contained morcellation using a specific specimen bag. Morcellation will be performed in the designated bag. The bag will then be removed evaluated for any egg albumin leakage. If there is no leakage, it can be inferred that there is no tissue is spread during the contained morcellation process using this bag.
Study:
NCT02777203
Study Brief:
Protocol Section:
NCT02777203