National Institute for Health and Care Excellence (NICE)
National Institute for Health and Care Excellence (NICE) in its recently published recommendations observed that myomectomy without morcellation is also associated with a risk of disseminating previously undiagnosed malignancy.
The committee also noted that containment systems (the in-bag technique) were increasingly used in this procedure with the aim of reducing the risk of disseminating benign or malignant cells.
https://www.nice.org.uk/guidance/ipg703/chapter/1-Recommendations
Laparoscopic myomectomy versus open myomectomy in uterine fibroid treatment: A meta-analysis
Laparoscopic myomectomy demonstrated sufficient advantages compared to open myomectomy in terms of overall complications including blood loss, reduction in hemoglobin, and pain intensity.
This meta-analysis showed that laparoscopic myomectomy exhibited superior results in terms of post-operative pain, blood loss, decreased hemoglobin levels, and overall complications; while open myomectomy comprised a shorter operative time.
https://www.sciencedirect.com/science/article/pii/S2468900921000396
Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial
We think that once the surgeon has learned how to use the bag, the time to place the bag is no longer than the time to recover the scattered fragments. There have been no significant changes in the assessment of its use or in the duration of bag placement during the study. This may indicate that the learning curve is quick.
Morcellation of the Uterus: Is There Any Place?
Results imply that there is a spillage of malignant cells already after enucleation and that in-bag morcellation prevents over 90% of abdominal contamination.
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) has recommended performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system to isolate and contain tissue that is considered benign.
https://www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellationLaparoscopic management of uncommon benign uterine tumors: a systematic review
The objective of the study was to review the reported cases of uncommon benign uterine tumors managed by laparoscopy. Medline database was searched using predefined search terms linked to atypical leiomyomas, leiomyoma variants, laparoscopy and morcellation. Quality of articles was assessed using Joanna Briggs Institute (JBI) critical appraisal tool. Due to heterogeneity in reporting characteristics of the patients, radiological findings, macroscopic findings, histological characteristics and follow-up, we performed a narrative synthesis. We included 109 cases of leiomyoma variants managed by laparoscopy. This stands for an incidence of 2.5% out of all the included laparoscopic management of leiomyomas. These cases were approached as classic leiomyoma. Only after the final histological results that their uncommon aspect was diagnosed. Intra-operatively, the management was similar to that of leiomyoma, with either myomectomy or hysterectomy performed depending on each individual case. Follow-up of these cases was variable: one case (0.9%) recurred as peritoneal sarcoma after 5 years of follow-up. It is important for the gynecologist, radiologist and pathologist to be aware about leiomyoma variants trying to diagnose them preoperatively. Strict follow-up of these cases is mandatory, because of the risk of recurrence and the very low but possible risk of future sarcomas.
Laparoscopic In‑Bag Morcellation Compared with Conventional Morcellation of Myomas and Uterus with Myomas MorSafe
As seen, the technique of contained morcellation proves to be acceptable, safe and can be mastered by gynaecologists globally.
Our study of contained morcellation protects the interest of a few million women who are bereaved of the benefit of laparoscopic minimal access surgery, forcing to resort to open surgery or widening the minimal access port.
Benefits and Limitations of Laparoscopic Myomectomy
Laparoscopic myomectomy, a popular minimal invasive technique, has been widely used for removal of uterine fibroid over the past decades. Initially it seems costly procedure due to its higher direct costs but shorter hospital stay, quick postoperative recovery and lower analgesic requirement might compensate the higher direct costs. Moreover, laparoscopy minimizes the risk of adhesion formation. Therefore, laparoscopy should be standard approach for myomectomy.
https://www.scirp.org/journal/paperinformation.aspx?paperid=90897
A case of solid ovarian tumor extracted with a new tool, MorSafe™.
A 33-year-old gravida 0 para 0 woman presented to our hospital with lower abdominal pain continuing for an hour. A hard tumor with tenderness on the right side of the uterus was found in pelvic examination. Transvaginal ultrasound revealed an ovarian tumor. It was 8 cm in diameter, solid, smooth-marginated and isodense. There was neither blood flow in color Doppler, nor ascites around the tumor. Tumor markers were not elevated. We suspected benign ovarian tumor such as fibroma. The patient hoped to preserve her ovaries. We performed laparoscopic ovarian tumorectomy and used MorSafe™ for morcellation and extraction of the tumor. We completed tumorectomy with no damage of MorSafe™. The ovarian tumor was 172 g, and the pathological diagnosis was fibroma with no malignancy. Laparoscopic ovarian tumorectomy is widely performed in cases of benign ovarian tumor, especially in young women. Gynecologists have an issue with extracting resected tumor, but there is no established method. Morcellation is an option to extract the resected tumor without further invasion, but there is a concern that power morcellation in abdominal cavity can spread the tumor. MorSafe™ is a new device that prevents the tumor from scattering. Some cases of morcellation in uterine leiomyoma with this device have been reported but there is no report of morcellation with MorSafe™ for an ovarian tumor. With this device, we performed a safe morcellation in a case of ovarian fibroma. Morcellation with MorSafe™ was a useful method to extract solid ovarian tumor.
Initial Experience Using Morsafe
MorSafe® Bag is a useful tool to help gynecologist to keep performing myomectomies and hysterectomies without spreading any tissue in the abdominal cavity. Its additional advantage is to avoid accidents because after the insufflation of the bag the distance between the tissue to be morcellated and the abdominal organs become wider. The time between the insertion of the MorSafe® Bag and the start of the morcellation did not compromise the total time of procedures. Contained power morcellation within an insufflated isolation bag will become a standard procedure in a near future.
Total Laparoscopic Hysterectomy with Contained Power Morcellation System in Large Uteri
MorSafe® is an isolation bag for power morcellation to avoid spreading myomas during morcellation. Using an isolation bag during morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery, the purpose of this video is to demonstrate the each step of bag morcellation during laproscopy.This technique involves inserting the isolation bag in to the abdomen, where tissue for removal was placed within the bag .The surgeon then pulled the opening of the bag to the exterior of the abdomen ,inflated the bag and fragmented the tissue within the bag to contain and remove it. After each procedure, the surgeon visually inspected the isolation bag for tears, as well as the abdominal and peritoneal cavities for tissue pieces left behind.
Feasibility of myomatous tissue extraction in laparoscopic surgery by contained in – bag morcellation: a retrospective single arm study MorSafe
Contained in – bag morcellation as innovative technique of tissue extraction proved to be a safe and feasible laparoscopic method potentially reducing the risk of dissemination in benign disease and in case of unsuspected malignancy, maximizing the patients’ safety and meanwhile preserving the advantages of minimally invasive surgery.
Conforming the literature data, the present series showed effective implementation of contained in – bag retrieval of the intraoperative specimens, even in very large myomatosus tissue. This study strengths are the highest number of in – bag morcellation and the largest weight of extirpated tissue.
An important advantage of the bag as contained system is that no after – morcellation intra – abdominal peritoneal cleaning is necessary, thus improving the patient’s safety and saving surgery time.
Contained Morcellation: Review of Current Methods and Future Directions
Enes Taylan in his article “Contained Morcellation: Review of Current Methods and Future Directions” describes how new approaches of contained or in-bag Morcellation methods prevent the additional risk and complications associated with dissemination of tissues inside the abdominal cavity. Power Morcellation has been introduced to modern surgical practices which provide the opportunity to perform several minimally invasive procedures but it involves potential risks like inflammation, infection, unintentional dissemination of malignant cells etc. After two decades of surgical practice with power morcellators, FDA released a warning statement discouraging the use of Power morcellator in women based on safety concerns. To overcome the challenges and eliminate tissue dissemination during Morcellation researcher developed the “In-bag Morcellation technique” as contained Morcellation method for multiple laparoscopic surgeries. In developing phase of contained Morcellation, recently Paul et al. described the use of specially designed isolation bag (MorSafe; Veol Medical Technologies, Mumbai, India) for two port Morcellation method. This method facilitates less operative time with better efficiency and feasibility. In-bag Morcellation with Power morcellator surgery facilitates the advantages of less perioperative complications, better results, faster recovery and improve the quality of life.
Demonstration of Bag Morcellation for Uterine Myomas: Educational Video
"Journal of Minimally Invasive Gynecology (JMIG)" published new developments of minimally invasive techniques. Its 23rd volume which was published in Nov/Dec-2016 describes MorSafe® as an isolation bag for power morcellation to avoid spreading myomas during morcellation. It has also mentioned that use of MorSafe® bag during Morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery. It also contains the short overview of Morcellation process using MorSafe® Tissue Morcellation Bag with Video.
Novel Technique for Contained Power Morcellation through Umbilicus with Insufflated Bag
In Apr 2014, the US Food and Drug Administration published a safety communication warning of the risk of an unsuspected uterine sarcoma being morcellated during a laparoscopic procedure and therefore advising against the use of power morcellation. These statements have encouraged the scientific community to look for new techniques that allows performing this procedure in a safer way, decreasing the risk of malignant dissemination thorough the abdominal cavity. We describe a new technique for power morcellation using a plastic bag through umbilicus using a latex glove and skin retractor as a single port device. This new procedure was performed in 4 women diagnosed with myomatous uterus. Median age was 40.5 years. No intraoperative complications, conversion to laparotomy or bag rupture occurred. Median surgical time was 195 min and median morcellation time was 48 min. Median in-hospital stay was 4.5 days. This new technique could be an acceptable and feasible alternative for specimen delivery during laparoscopic hysterectomy and myomectomy. However, it is still necessary to increase the number of procedures to assess its safety in case of uterine sarcoma.
Options on fibroid morcellation: a literature review
In laparoscopy, specimens have to be removed from the abdominal cavity. If the trocar opening or the vaginal outlet is insufficient to pass the specimen, the specimen needs to be reduced. The power morcellator is an instrument with a fast rotating cylindrical knife which aims to divide the tissue into smaller pieces or fragments. The Food and Drug Administration (FDA) issued a press release in Apr 2014 that discouraged the use of these power morcellators. This article has the objective to review the literature related to complications by power morcellation of uterine fibroids in laparoscopy and offer recommendations to laparoscopic surgeons in gynaecology. This project was initiated by the executive board of the European Society of Gynaecological Endoscopy. A steering committee on fibroid morcellation was installed and experienced ESGE members requested to chair an action group to address distinct clinical questions. Clinical questions were formulated with regards to the sarcoma risk in presumed uterine fibroids, diagnosis of sarcoma, complications of morcellation and future research. A literature review on the different subjects was conducted, systematic if appropriate and feasible. It was concluded that the true prevalence of uterine sarcoma in presumed fibroids is not known given the wide range of prevalences (0.45–0.014 %) from meta-analyses mainly based on retrospective trials. Age and certain imaging characteristics such as ‘lacunes’ suggesting necrosis and increased central vascularisation of the tumour are associated with a higher risk of uterine sarcoma, although the risks remain low. There is not enough evidence to estimate this risk in individual patients. Complications of morcellation are rare. Reported are direct morcellation injuries to vessels and bowel, the development of so-called parasitic fibroids requiring reintervention and the spread of sarcoma cells in the abdominal cavity, which may possibly or even likely upstaging the disease. Momentarily in-bag morcellation is investigated as it may possibly prevent morcellation complications. Because of lack of evidence, this literature review cannot give strong recommendations but offers only options which are condensed in a flow chart. Prospective data collection may clarify the issue on sarcoma risk in presumed fibroids and technology to extract tissue laparoscopically from the abdominal cavity should be perfected.
http://link.springer.com/article/10.1007%2Fs10397-015-0878-4
Laparoscopic Morcellation of Fibroid and Uterus In-Bag
Dr. Prakash Trivedi has described the In-bag Morcellation technique using MorSafe® in “The journal of Obstetrics and Gynecology”. Dr. Trivedi has successfully removed twenty-one cases of fibroid as big as 1.4kg, and also a case of seven fibroids varying in size (4-7 cm) were morcellated using MorSafe® for their retrieval. Dr. Trivedi claimed that the In-bag Morcellation using MorSafe® handles the issue of ULMS (Uterine Leiomyosarcoma) and makes laparoscopic myomectomy and hysterectomy possible with fair safety. It drops down the risk of spread and quick recovery is possible for the patient. He also suggests that further study should be directed towards identifying the patient at high risk of ULMS prior to presumed leiomyoma resection in order to reduce the risk of inadvertent tumor Morcellation.
Contained morcellation for laparoscopic myomectomy within a specially designed bag Versator and MorSafe
We have found that in- bag morcellation does not add substantially to the operative time especially beyond the learning curve. It does take some time to place the specimen in the bag initially, but the invested time is compensated for as small pieces of tissues that may be generated with power morcellation remain contained in the bag.
The benefits of morcellation under direct vision with an insufflated isolation bag include the potential reduction of tissue dissemination while preserving the well-known benefits of minimally invasive gynecological surgery. The cases presented in this series highlight the feasibility and reproducibility of this technique.
In-bag morcellation using this new bag (MorSafe®) is a feasible technique of morcellating uterine myomas in a contained manner and may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery.
Morcellation in Canada: Perspectives on Current Practices and Future Implications
In summary, laparoscopic power morcellation can provide patients considerable benefits in terms of facilitating a minimally invasive approach when uterine and/or fibroid size is large, thereby decreasing recovery time and perioperative risks.
British Society of Gynecological Endoscopy
As per British Society of Gynecological Endoscopy, there is a place for power morcellation in the management of women with uterine fibroids. Best evidence supports the use of a laparoscopic approach to myomectomy.
https://www.bsge.org.uk/news/bsge-statement-power-morcellation/
Minimally invasive surgical techniques versus open myomectomy for uterine fibroids (Review)
Results of our analysis have shown that postoperative febrile morbidity is less common in laparoscopic myomectomy than in all types of open myomectomy.
When laparoscopic myomectomy was compared with open myomectomy, a reduced haemoglobin drop was noted postoperatively, indicating decreased intraoperative blood loss in laparoscopic myomectomy
In-Bag Morcellation
In-bag morcellation seems to be a viable alternative to open power morcellation and offers the advantage of minimal to no spillage of tissue or fluids during morcellation. We report our initial experience and technique using this approach
American Association of Gynecologic Laparoscopists (AAGL)
AAGL in 2014 stated that we should improve but not abandon power morcellation and that power morcellation with appropriate informed consent should remain available to appropriately screened, low risk women.
In 2018, AAGL noted that the use of a containment bag may mitigate the risk of tissue spread during morcellation.
Surgical approach to three pediatric patients with ovarian tumors: laparoscopic excision using a specimen retrieval bag
Hybrid minimally invasive approach should be performed to decrease the risk for intraperitoneal spillage of cyst contents. Usage of a specimen retrieval bag could minimize intraperitoneal spillage of cyst contents.
Cite this article as: Tatekawa Y. Surgical approach to three pediatric patients with ovarian tumors: laparoscopic excision using a specimen retrieval bag. J Surg Case Rep. 2021 Nov 8;2021(11):rjab505. doi: 10.1093/jscr/rjab505. PMID: 34760219; PMCID: PMC8575496.
Port site endometrioma: a rare cause of abdominal wall pain following laparoscopic surgery
All tissues removed during laparoscopy should be placed in an appropriate retrieval bag.
Cite this article as: Siddiqui ZA, Husain F, Siddiqui Z, Siddiqui M. Port site endometrioma: a rare cause of abdominal wall pain following laparoscopic surgery. BMJ Case Rep. 2017 Jun 18;2017: bcr2017219291. doi: 10.1136/bcr-2017-219291. PMID: 28630240; PMCID: PMC5534730.
Pisat’s Visual Vasopressor Injection Needle: A New Instrument for enhancing Patient Safety in Laparoscopic Myomectomy
Using a VVIN, a volume of just 0.03 mL of blood is sufficient to detect a vascular puncture. This is lesser than one single drop of blood (approximately 0.05 mL), and about 27 times more sensitive than a regular injection needle, which requires about 0.8 mL of blood to show up as a positive aspirate in the syringe.
Use of this device significantly reduces the possibility of injecting the vasopressor solution in the vascular channels over the fibroid.
Cite this article as: Pisat S. Pisat’s Visual Vasopressor Injection Needle: A New Instrument for enhancing Patient Safety in Laparoscopic Myomectomy. Int J Gynecol Endsc 2018;2(1):4-5.
Link: https://www.ijoge.com/doi/IJGE/pdf/10.5005/jp-journals-10058-0025
Pisat’s Visual Vasopressor Injection Needle: A New Device for Increasing Patient Safety in Laparoscopic Myomectomy
Using a VVIN during a laparoscopic myomectomy enables the surgeon to detect an inadvertent vascular puncture very early, even in a small caliber blood vessel, and with much more sensitivity than a regular needle. This increases patient safety during the intra-myometrial injection of a vasoconstrictive agent during myomectomy and reduces the incidence of catastrophic complications.
Cite this article as: Pisat SV. Pisat's Visual Vasopressor Injection Needle: A New Device for Increasing Patient Safety in Laparoscopic Myomectomy. J Obstet Gynaecol India. 2017 Dec;67(6):451-453. doi: 10.1007/s13224-017-1048-6. Epub 2017 Sep 12. PMID: 29162961; PMCID: PMC5676578.
Laparoscopic myomectomy versus open myomectomy in uterine fibroid treatment: A meta-analysis
Laparoscopic myomectomy demonstrated sufficient advantages compared to open myomectomy in terms of overall complications including blood loss, reduction in hemoglobin, and pain intensity.
This meta-analysis showed that laparoscopic myomectomy exhibited superior results in terms of post-operative pain, blood loss, decreased hemoglobin levels, and overall complications; while open myomectomy comprised a shorter operative time.
https://www.sciencedirect.com/science/article/pii/S2468900921000396
Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial
We think that once the surgeon has learned how to use the bag, the time to place the bag is no longer than the time to recover the scattered fragments. There have been no significant changes in the assessment of its use or in the duration of bag placement during the study. This may indicate that the learning curve is quick.
Morcellation of the Uterus: Is There Any Place?
Results imply that there is a spillage of malignant cells already after enucleation and that in-bag morcellation prevents over 90% of abdominal contamination.
Laparoscopic management of uncommon benign uterine tumors: a systematic review
The objective of the study was to review the reported cases of uncommon benign uterine tumors managed by laparoscopy. Medline database was searched using predefined search terms linked to atypical leiomyomas, leiomyoma variants, laparoscopy and morcellation. Quality of articles was assessed using Joanna Briggs Institute (JBI) critical appraisal tool. Due to heterogeneity in reporting characteristics of the patients, radiological findings, macroscopic findings, histological characteristics and follow-up, we performed a narrative synthesis. We included 109 cases of leiomyoma variants managed by laparoscopy. This stands for an incidence of 2.5% out of all the included laparoscopic management of leiomyomas. These cases were approached as classic leiomyoma. Only after the final histological results that their uncommon aspect was diagnosed. Intra-operatively, the management was similar to that of leiomyoma, with either myomectomy or hysterectomy performed depending on each individual case. Follow-up of these cases was variable: one case (0.9%) recurred as peritoneal sarcoma after 5 years of follow-up. It is important for the gynecologist, radiologist and pathologist to be aware about leiomyoma variants trying to diagnose them preoperatively. Strict follow-up of these cases is mandatory, because of the risk of recurrence and the very low but possible risk of future sarcomas.
Laparoscopic In‑Bag Morcellation Compared with Conventional Morcellation of Myomas and Uterus with Myomas MorSafe
As seen, the technique of contained morcellation proves to be acceptable, safe and can be mastered by gynaecologists globally.
Our study of contained morcellation protects the interest of a few million women who are bereaved of the benefit of laparoscopic minimal access surgery, forcing to resort to open surgery or widening the minimal access port.
Benefits and Limitations of Laparoscopic Myomectomy
Laparoscopic myomectomy, a popular minimal invasive technique, has been widely used for removal of uterine fibroid over the past decades. Initially it seems costly procedure due to its higher direct costs but shorter hospital stay, quick postoperative recovery and lower analgesic requirement might compensate the higher direct costs. Moreover, laparoscopy minimizes the risk of adhesion formation. Therefore, laparoscopy should be standard approach for myomectomy.
https://www.scirp.org/journal/paperinformation.aspx?paperid=90897
A case of solid ovarian tumor extracted with a new tool, MorSafe™.
A 33-year-old gravida 0 para 0 woman presented to our hospital with lower abdominal pain continuing for an hour. A hard tumor with tenderness on the right side of the uterus was found in pelvic examination. Transvaginal ultrasound revealed an ovarian tumor. It was 8 cm in diameter, solid, smooth-marginated and isodense. There was neither blood flow in color Doppler, nor ascites around the tumor. Tumor markers were not elevated. We suspected benign ovarian tumor such as fibroma. The patient hoped to preserve her ovaries. We performed laparoscopic ovarian tumorectomy and used MorSafe™ for morcellation and extraction of the tumor. We completed tumorectomy with no damage of MorSafe™. The ovarian tumor was 172 g, and the pathological diagnosis was fibroma with no malignancy. Laparoscopic ovarian tumorectomy is widely performed in cases of benign ovarian tumor, especially in young women. Gynecologists have an issue with extracting resected tumor, but there is no established method. Morcellation is an option to extract the resected tumor without further invasion, but there is a concern that power morcellation in abdominal cavity can spread the tumor. MorSafe™ is a new device that prevents the tumor from scattering. Some cases of morcellation in uterine leiomyoma with this device have been reported but there is no report of morcellation with MorSafe™ for an ovarian tumor. With this device, we performed a safe morcellation in a case of ovarian fibroma. Morcellation with MorSafe™ was a useful method to extract solid ovarian tumor.
Initial Experience Using Morsafe
MorSafe® Bag is a useful tool to help gynecologist to keep performing myomectomies and hysterectomies without spreading any tissue in the abdominal cavity. Its additional advantage is to avoid accidents because after the insufflation of the bag the distance between the tissue to be morcellated and the abdominal organs become wider. The time between the insertion of the MorSafe® Bag and the start of the morcellation did not compromise the total time of procedures. Contained power morcellation within an insufflated isolation bag will become a standard procedure in a near future.
Total Laparoscopic Hysterectomy with Contained Power Morcellation System in Large Uteri
MorSafe® is an isolation bag for power morcellation to avoid spreading myomas during morcellation. Using an isolation bag during morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery, the purpose of this video is to demonstrate the each step of bag morcellation during laproscopy.This technique involves inserting the isolation bag in to the abdomen, where tissue for removal was placed within the bag .The surgeon then pulled the opening of the bag to the exterior of the abdomen ,inflated the bag and fragmented the tissue within the bag to contain and remove it. After each procedure, the surgeon visually inspected the isolation bag for tears, as well as the abdominal and peritoneal cavities for tissue pieces left behind.
Feasibility of myomatous tissue extraction in laparoscopic surgery by contained in – bag morcellation: a retrospective single arm study MorSafe
Contained in – bag morcellation as innovative technique of tissue extraction proved to be a safe and feasible laparoscopic method potentially reducing the risk of dissemination in benign disease and in case of unsuspected malignancy, maximizing the patients’ safety and meanwhile preserving the advantages of minimally invasive surgery.
Conforming the literature data, the present series showed effective implementation of contained in – bag retrieval of the intraoperative specimens, even in very large myomatosus tissue. This study strengths are the highest number of in – bag morcellation and the largest weight of extirpated tissue.
An important advantage of the bag as contained system is that no after – morcellation intra – abdominal peritoneal cleaning is necessary, thus improving the patient’s safety and saving surgery time.
Contained Morcellation: Review of Current Methods and Future Directions
Enes Taylan in his article “Contained Morcellation: Review of Current Methods and Future Directions” describes how new approaches of contained or in-bag Morcellation methods prevent the additional risk and complications associated with dissemination of tissues inside the abdominal cavity. Power Morcellation has been introduced to modern surgical practices which provide the opportunity to perform several minimally invasive procedures but it involves potential risks like inflammation, infection, unintentional dissemination of malignant cells etc. After two decades of surgical practice with power morcellators, FDA released a warning statement discouraging the use of Power morcellator in women based on safety concerns. To overcome the challenges and eliminate tissue dissemination during Morcellation researcher developed the “In-bag Morcellation technique” as contained Morcellation method for multiple laparoscopic surgeries. In developing phase of contained Morcellation, recently Paul et al. described the use of specially designed isolation bag (MorSafe; Veol Medical Technologies, Mumbai, India) for two port Morcellation method. This method facilitates less operative time with better efficiency and feasibility. In-bag Morcellation with Power morcellator surgery facilitates the advantages of less perioperative complications, better results, faster recovery and improve the quality of life.
Demonstration of Bag Morcellation for Uterine Myomas: Educational Video
"Journal of Minimally Invasive Gynecology (JMIG)" published new developments of minimally invasive techniques. Its 23rd volume which was published in Nov/Dec-2016 describes MorSafe® as an isolation bag for power morcellation to avoid spreading myomas during morcellation. It has also mentioned that use of MorSafe® bag during Morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery. It also contains the short overview of Morcellation process using MorSafe® Tissue Morcellation Bag with Video.
Novel Technique for Contained Power Morcellation through Umbilicus with Insufflated Bag
In Apr 2014, the US Food and Drug Administration published a safety communication warning of the risk of an unsuspected uterine sarcoma being morcellated during a laparoscopic procedure and therefore advising against the use of power morcellation. These statements have encouraged the scientific community to look for new techniques that allows performing this procedure in a safer way, decreasing the risk of malignant dissemination thorough the abdominal cavity. We describe a new technique for power morcellation using a plastic bag through umbilicus using a latex glove and skin retractor as a single port device. This new procedure was performed in 4 women diagnosed with myomatous uterus. Median age was 40.5 years. No intraoperative complications, conversion to laparotomy or bag rupture occurred. Median surgical time was 195 min and median morcellation time was 48 min. Median in-hospital stay was 4.5 days. This new technique could be an acceptable and feasible alternative for specimen delivery during laparoscopic hysterectomy and myomectomy. However, it is still necessary to increase the number of procedures to assess its safety in case of uterine sarcoma.
Options on fibroid morcellation: a literature review
In laparoscopy, specimens have to be removed from the abdominal cavity. If the trocar opening or the vaginal outlet is insufficient to pass the specimen, the specimen needs to be reduced. The power morcellator is an instrument with a fast rotating cylindrical knife which aims to divide the tissue into smaller pieces or fragments. The Food and Drug Administration (FDA) issued a press release in Apr 2014 that discouraged the use of these power morcellators. This article has the objective to review the literature related to complications by power morcellation of uterine fibroids in laparoscopy and offer recommendations to laparoscopic surgeons in gynaecology. This project was initiated by the executive board of the European Society of Gynaecological Endoscopy. A steering committee on fibroid morcellation was installed and experienced ESGE members requested to chair an action group to address distinct clinical questions. Clinical questions were formulated with regards to the sarcoma risk in presumed uterine fibroids, diagnosis of sarcoma, complications of morcellation and future research. A literature review on the different subjects was conducted, systematic if appropriate and feasible. It was concluded that the true prevalence of uterine sarcoma in presumed fibroids is not known given the wide range of prevalences (0.45–0.014 %) from meta-analyses mainly based on retrospective trials. Age and certain imaging characteristics such as ‘lacunes’ suggesting necrosis and increased central vascularisation of the tumour are associated with a higher risk of uterine sarcoma, although the risks remain low. There is not enough evidence to estimate this risk in individual patients. Complications of morcellation are rare. Reported are direct morcellation injuries to vessels and bowel, the development of so-called parasitic fibroids requiring reintervention and the spread of sarcoma cells in the abdominal cavity, which may possibly or even likely upstaging the disease. Momentarily in-bag morcellation is investigated as it may possibly prevent morcellation complications. Because of lack of evidence, this literature review cannot give strong recommendations but offers only options which are condensed in a flow chart. Prospective data collection may clarify the issue on sarcoma risk in presumed fibroids and technology to extract tissue laparoscopically from the abdominal cavity should be perfected.
http://link.springer.com/article/10.1007%2Fs10397-015-0878-4
Laparoscopic Morcellation of Fibroid and Uterus In-Bag
Dr. Prakash Trivedi has described the In-bag Morcellation technique using MorSafe® in “The journal of Obstetrics and Gynecology”. Dr. Trivedi has successfully removed twenty-one cases of fibroid as big as 1.4kg, and also a case of seven fibroids varying in size (4-7 cm) were morcellated using MorSafe® for their retrieval. Dr. Trivedi claimed that the In-bag Morcellation using MorSafe® handles the issue of ULMS (Uterine Leiomyosarcoma) and makes laparoscopic myomectomy and hysterectomy possible with fair safety. It drops down the risk of spread and quick recovery is possible for the patient. He also suggests that further study should be directed towards identifying the patient at high risk of ULMS prior to presumed leiomyoma resection in order to reduce the risk of inadvertent tumor Morcellation.
Contained morcellation for laparoscopic myomectomy within a specially designed bag Versator and MorSafe
We have found that in- bag morcellation does not add substantially to the operative time especially beyond the learning curve. It does take some time to place the specimen in the bag initially, but the invested time is compensated for as small pieces of tissues that may be generated with power morcellation remain contained in the bag.
The benefits of morcellation under direct vision with an insufflated isolation bag include the potential reduction of tissue dissemination while preserving the well-known benefits of minimally invasive gynecological surgery. The cases presented in this series highlight the feasibility and reproducibility of this technique.
In-bag morcellation using this new bag (MorSafe®) is a feasible technique of morcellating uterine myomas in a contained manner and may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery.
Morcellation in Canada: Perspectives on Current Practices and Future Implications
In summary, laparoscopic power morcellation can provide patients considerable benefits in terms of facilitating a minimally invasive approach when uterine and/or fibroid size is large, thereby decreasing recovery time and perioperative risks.
Minimally invasive surgical techniques versus open myomectomy for uterine fibroids (Review)
Results of our analysis have shown that postoperative febrile morbidity is less common in laparoscopic myomectomy than in all types of open myomectomy.
When laparoscopic myomectomy was compared with open myomectomy, a reduced haemoglobin drop was noted postoperatively, indicating decreased intraoperative blood loss in laparoscopic myomectomy
In-Bag Morcellation
In-bag morcellation seems to be a viable alternative to open power morcellation and offers the advantage of minimal to no spillage of tissue or fluids during morcellation. We report our initial experience and technique using this approach
Laparoscopic myomectomy versus open myomectomy in uterine fibroid treatment: A meta-analysis
Laparoscopic myomectomy demonstrated sufficient advantages compared to open myomectomy in terms of overall complications including blood loss, reduction in hemoglobin, and pain intensity.
This meta-analysis showed that laparoscopic myomectomy exhibited superior results in terms of post-operative pain, blood loss, decreased hemoglobin levels, and overall complications; while open myomectomy comprised a shorter operative time.
https://www.sciencedirect.com/science/article/pii/S2468900921000396
Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial
We think that once the surgeon has learned how to use the bag, the time to place the bag is no longer than the time to recover the scattered fragments. There have been no significant changes in the assessment of its use or in the duration of bag placement during the study. This may indicate that the learning curve is quick.
Morcellation of the Uterus: Is There Any Place?
Results imply that there is a spillage of malignant cells already after enucleation and that in-bag morcellation prevents over 90% of abdominal contamination.
Laparoscopic management of uncommon benign uterine tumors: a systematic review
The objective of the study was to review the reported cases of uncommon benign uterine tumors managed by laparoscopy. Medline database was searched using predefined search terms linked to atypical leiomyomas, leiomyoma variants, laparoscopy and morcellation. Quality of articles was assessed using Joanna Briggs Institute (JBI) critical appraisal tool. Due to heterogeneity in reporting characteristics of the patients, radiological findings, macroscopic findings, histological characteristics and follow-up, we performed a narrative synthesis. We included 109 cases of leiomyoma variants managed by laparoscopy. This stands for an incidence of 2.5% out of all the included laparoscopic management of leiomyomas. These cases were approached as classic leiomyoma. Only after the final histological results that their uncommon aspect was diagnosed. Intra-operatively, the management was similar to that of leiomyoma, with either myomectomy or hysterectomy performed depending on each individual case. Follow-up of these cases was variable: one case (0.9%) recurred as peritoneal sarcoma after 5 years of follow-up. It is important for the gynecologist, radiologist and pathologist to be aware about leiomyoma variants trying to diagnose them preoperatively. Strict follow-up of these cases is mandatory, because of the risk of recurrence and the very low but possible risk of future sarcomas.
Laparoscopic In‑Bag Morcellation Compared with Conventional Morcellation of Myomas and Uterus with Myomas MorSafe
As seen, the technique of contained morcellation proves to be acceptable, safe and can be mastered by gynaecologists globally.
Our study of contained morcellation protects the interest of a few million women who are bereaved of the benefit of laparoscopic minimal access surgery, forcing to resort to open surgery or widening the minimal access port.
Benefits and Limitations of Laparoscopic Myomectomy
Laparoscopic myomectomy, a popular minimal invasive technique, has been widely used for removal of uterine fibroid over the past decades. Initially it seems costly procedure due to its higher direct costs but shorter hospital stay, quick postoperative recovery and lower analgesic requirement might compensate the higher direct costs. Moreover, laparoscopy minimizes the risk of adhesion formation. Therefore, laparoscopy should be standard approach for myomectomy.
https://www.scirp.org/journal/paperinformation.aspx?paperid=90897
A case of solid ovarian tumor extracted with a new tool, MorSafe™.
A 33-year-old gravida 0 para 0 woman presented to our hospital with lower abdominal pain continuing for an hour. A hard tumor with tenderness on the right side of the uterus was found in pelvic examination. Transvaginal ultrasound revealed an ovarian tumor. It was 8 cm in diameter, solid, smooth-marginated and isodense. There was neither blood flow in color Doppler, nor ascites around the tumor. Tumor markers were not elevated. We suspected benign ovarian tumor such as fibroma. The patient hoped to preserve her ovaries. We performed laparoscopic ovarian tumorectomy and used MorSafe™ for morcellation and extraction of the tumor. We completed tumorectomy with no damage of MorSafe™. The ovarian tumor was 172 g, and the pathological diagnosis was fibroma with no malignancy. Laparoscopic ovarian tumorectomy is widely performed in cases of benign ovarian tumor, especially in young women. Gynecologists have an issue with extracting resected tumor, but there is no established method. Morcellation is an option to extract the resected tumor without further invasion, but there is a concern that power morcellation in abdominal cavity can spread the tumor. MorSafe™ is a new device that prevents the tumor from scattering. Some cases of morcellation in uterine leiomyoma with this device have been reported but there is no report of morcellation with MorSafe™ for an ovarian tumor. With this device, we performed a safe morcellation in a case of ovarian fibroma. Morcellation with MorSafe™ was a useful method to extract solid ovarian tumor.
Initial Experience Using Morsafe
MorSafe® Bag is a useful tool to help gynecologist to keep performing myomectomies and hysterectomies without spreading any tissue in the abdominal cavity. Its additional advantage is to avoid accidents because after the insufflation of the bag the distance between the tissue to be morcellated and the abdominal organs become wider. The time between the insertion of the MorSafe® Bag and the start of the morcellation did not compromise the total time of procedures. Contained power morcellation within an insufflated isolation bag will become a standard procedure in a near future.
Total Laparoscopic Hysterectomy with Contained Power Morcellation System in Large Uteri
MorSafe® is an isolation bag for power morcellation to avoid spreading myomas during morcellation. Using an isolation bag during morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery, the purpose of this video is to demonstrate the each step of bag morcellation during laproscopy.This technique involves inserting the isolation bag in to the abdomen, where tissue for removal was placed within the bag .The surgeon then pulled the opening of the bag to the exterior of the abdomen ,inflated the bag and fragmented the tissue within the bag to contain and remove it. After each procedure, the surgeon visually inspected the isolation bag for tears, as well as the abdominal and peritoneal cavities for tissue pieces left behind.
Feasibility of myomatous tissue extraction in laparoscopic surgery by contained in – bag morcellation: a retrospective single arm study MorSafe
Contained in – bag morcellation as innovative technique of tissue extraction proved to be a safe and feasible laparoscopic method potentially reducing the risk of dissemination in benign disease and in case of unsuspected malignancy, maximizing the patients’ safety and meanwhile preserving the advantages of minimally invasive surgery.
Conforming the literature data, the present series showed effective implementation of contained in – bag retrieval of the intraoperative specimens, even in very large myomatosus tissue. This study strengths are the highest number of in – bag morcellation and the largest weight of extirpated tissue.
An important advantage of the bag as contained system is that no after – morcellation intra – abdominal peritoneal cleaning is necessary, thus improving the patient’s safety and saving surgery time.
Contained Morcellation: Review of Current Methods and Future Directions
Enes Taylan in his article “Contained Morcellation: Review of Current Methods and Future Directions” describes how new approaches of contained or in-bag Morcellation methods prevent the additional risk and complications associated with dissemination of tissues inside the abdominal cavity. Power Morcellation has been introduced to modern surgical practices which provide the opportunity to perform several minimally invasive procedures but it involves potential risks like inflammation, infection, unintentional dissemination of malignant cells etc. After two decades of surgical practice with power morcellators, FDA released a warning statement discouraging the use of Power morcellator in women based on safety concerns. To overcome the challenges and eliminate tissue dissemination during Morcellation researcher developed the “In-bag Morcellation technique” as contained Morcellation method for multiple laparoscopic surgeries. In developing phase of contained Morcellation, recently Paul et al. described the use of specially designed isolation bag (MorSafe; Veol Medical Technologies, Mumbai, India) for two port Morcellation method. This method facilitates less operative time with better efficiency and feasibility. In-bag Morcellation with Power morcellator surgery facilitates the advantages of less perioperative complications, better results, faster recovery and improve the quality of life.
Demonstration of Bag Morcellation for Uterine Myomas: Educational Video
"Journal of Minimally Invasive Gynecology (JMIG)" published new developments of minimally invasive techniques. Its 23rd volume which was published in Nov/Dec-2016 describes MorSafe® as an isolation bag for power morcellation to avoid spreading myomas during morcellation. It has also mentioned that use of MorSafe® bag during Morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery. It also contains the short overview of Morcellation process using MorSafe® Tissue Morcellation Bag with Video.
Novel Technique for Contained Power Morcellation through Umbilicus with Insufflated Bag
In Apr 2014, the US Food and Drug Administration published a safety communication warning of the risk of an unsuspected uterine sarcoma being morcellated during a laparoscopic procedure and therefore advising against the use of power morcellation. These statements have encouraged the scientific community to look for new techniques that allows performing this procedure in a safer way, decreasing the risk of malignant dissemination thorough the abdominal cavity. We describe a new technique for power morcellation using a plastic bag through umbilicus using a latex glove and skin retractor as a single port device. This new procedure was performed in 4 women diagnosed with myomatous uterus. Median age was 40.5 years. No intraoperative complications, conversion to laparotomy or bag rupture occurred. Median surgical time was 195 min and median morcellation time was 48 min. Median in-hospital stay was 4.5 days. This new technique could be an acceptable and feasible alternative for specimen delivery during laparoscopic hysterectomy and myomectomy. However, it is still necessary to increase the number of procedures to assess its safety in case of uterine sarcoma.
Options on fibroid morcellation: a literature review
In laparoscopy, specimens have to be removed from the abdominal cavity. If the trocar opening or the vaginal outlet is insufficient to pass the specimen, the specimen needs to be reduced. The power morcellator is an instrument with a fast rotating cylindrical knife which aims to divide the tissue into smaller pieces or fragments. The Food and Drug Administration (FDA) issued a press release in Apr 2014 that discouraged the use of these power morcellators. This article has the objective to review the literature related to complications by power morcellation of uterine fibroids in laparoscopy and offer recommendations to laparoscopic surgeons in gynaecology. This project was initiated by the executive board of the European Society of Gynaecological Endoscopy. A steering committee on fibroid morcellation was installed and experienced ESGE members requested to chair an action group to address distinct clinical questions. Clinical questions were formulated with regards to the sarcoma risk in presumed uterine fibroids, diagnosis of sarcoma, complications of morcellation and future research. A literature review on the different subjects was conducted, systematic if appropriate and feasible. It was concluded that the true prevalence of uterine sarcoma in presumed fibroids is not known given the wide range of prevalences (0.45–0.014 %) from meta-analyses mainly based on retrospective trials. Age and certain imaging characteristics such as ‘lacunes’ suggesting necrosis and increased central vascularisation of the tumour are associated with a higher risk of uterine sarcoma, although the risks remain low. There is not enough evidence to estimate this risk in individual patients. Complications of morcellation are rare. Reported are direct morcellation injuries to vessels and bowel, the development of so-called parasitic fibroids requiring reintervention and the spread of sarcoma cells in the abdominal cavity, which may possibly or even likely upstaging the disease. Momentarily in-bag morcellation is investigated as it may possibly prevent morcellation complications. Because of lack of evidence, this literature review cannot give strong recommendations but offers only options which are condensed in a flow chart. Prospective data collection may clarify the issue on sarcoma risk in presumed fibroids and technology to extract tissue laparoscopically from the abdominal cavity should be perfected.
http://link.springer.com/article/10.1007%2Fs10397-015-0878-4
Laparoscopic Morcellation of Fibroid and Uterus In-Bag
Dr. Prakash Trivedi has described the In-bag Morcellation technique using MorSafe® in “The journal of Obstetrics and Gynecology”. Dr. Trivedi has successfully removed twenty-one cases of fibroid as big as 1.4kg, and also a case of seven fibroids varying in size (4-7 cm) were morcellated using MorSafe® for their retrieval. Dr. Trivedi claimed that the In-bag Morcellation using MorSafe® handles the issue of ULMS (Uterine Leiomyosarcoma) and makes laparoscopic myomectomy and hysterectomy possible with fair safety. It drops down the risk of spread and quick recovery is possible for the patient. He also suggests that further study should be directed towards identifying the patient at high risk of ULMS prior to presumed leiomyoma resection in order to reduce the risk of inadvertent tumor Morcellation.
Contained morcellation for laparoscopic myomectomy within a specially designed bag Versator and MorSafe
We have found that in- bag morcellation does not add substantially to the operative time especially beyond the learning curve. It does take some time to place the specimen in the bag initially, but the invested time is compensated for as small pieces of tissues that may be generated with power morcellation remain contained in the bag.
The benefits of morcellation under direct vision with an insufflated isolation bag include the potential reduction of tissue dissemination while preserving the well-known benefits of minimally invasive gynecological surgery. The cases presented in this series highlight the feasibility and reproducibility of this technique.
In-bag morcellation using this new bag (MorSafe®) is a feasible technique of morcellating uterine myomas in a contained manner and may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery.
Morcellation in Canada: Perspectives on Current Practices and Future Implications
In summary, laparoscopic power morcellation can provide patients considerable benefits in terms of facilitating a minimally invasive approach when uterine and/or fibroid size is large, thereby decreasing recovery time and perioperative risks.
Minimally invasive surgical techniques versus open myomectomy for uterine fibroids (Review)
Results of our analysis have shown that postoperative febrile morbidity is less common in laparoscopic myomectomy than in all types of open myomectomy.
When laparoscopic myomectomy was compared with open myomectomy, a reduced haemoglobin drop was noted postoperatively, indicating decreased intraoperative blood loss in laparoscopic myomectomy
In-Bag Morcellation
In-bag morcellation seems to be a viable alternative to open power morcellation and offers the advantage of minimal to no spillage of tissue or fluids during morcellation. We report our initial experience and technique using this approach
National Institute for Health and Care Excellence (NICE)
National Institute for Health and Care Excellence (NICE) in its recently published recommendations observed that myomectomy without morcellation is also associated with a risk of disseminating previously undiagnosed malignancy.
The committee also noted that containment systems (the in-bag technique) were increasingly used in this procedure with the aim of reducing the risk of disseminating benign or malignant cells.
https://www.nice.org.uk/guidance/ipg703/chapter/1-Recommendations
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) has recommended performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system to isolate and contain tissue that is considered benign.
https://www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellationBritish Society of Gynecological Endoscopy
As per British Society of Gynecological Endoscopy, there is a place for power morcellation in the management of women with uterine fibroids. Best evidence supports the use of a laparoscopic approach to myomectomy.
https://www.bsge.org.uk/news/bsge-statement-power-morcellation/
American Association of Gynecologic Laparoscopists (AAGL)
AAGL in 2014 stated that we should improve but not abandon power morcellation and that power morcellation with appropriate informed consent should remain available to appropriately screened, low risk women.
In 2018, AAGL noted that the use of a containment bag may mitigate the risk of tissue spread during morcellation.
National Institute for Health and Care Excellence (NICE)
National Institute for Health and Care Excellence (NICE) in its recently published recommendations observed that myomectomy without morcellation is also associated with a risk of disseminating previously undiagnosed malignancy.
The committee also noted that containment systems (the in-bag technique) were increasingly used in this procedure with the aim of reducing the risk of disseminating benign or malignant cells.
https://www.nice.org.uk/guidance/ipg703/chapter/1-Recommendations
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) has recommended performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system to isolate and contain tissue that is considered benign.
https://www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellationBritish Society of Gynecological Endoscopy
As per British Society of Gynecological Endoscopy, there is a place for power morcellation in the management of women with uterine fibroids. Best evidence supports the use of a laparoscopic approach to myomectomy.
https://www.bsge.org.uk/news/bsge-statement-power-morcellation/
American Association of Gynecologic Laparoscopists (AAGL)
AAGL in 2014 stated that we should improve but not abandon power morcellation and that power morcellation with appropriate informed consent should remain available to appropriately screened, low risk women.
In 2018, AAGL noted that the use of a containment bag may mitigate the risk of tissue spread during morcellation.
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