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Obstetrics and Gynecology Apr 2019To characterize long-term national trends in surgical approach for hysterectomy after the U.S. Food and Drug Administration (FDA) warning against power morcellation for...
OBJECTIVE
To characterize long-term national trends in surgical approach for hysterectomy after the U.S. Food and Drug Administration (FDA) warning against power morcellation for laparoscopic specimen removal.
METHODS
This was a descriptive study using data from the American College of Surgeons National Surgical Quality Improvement Program from 2012 to 2016. We identified hysterectomies using Current Procedural Terminology codes. We used an interrupted time-series analysis to evaluate abdominal and supracervical hysterectomy trends surrounding The Wall Street Journal article first reporting morcellation safety concerns and the FDA safety communication. We compared categorical and continuous variables using χ, t, and Wilcoxon rank sum tests.
RESULTS
We identified 179,950 hysterectomies; laparoscopy was the most common mode of hysterectomy in every quarter. Before The Wall Street Journal article, there was no significant change in proportion of abdominal hysterectomies (0.3% decrease/quarter, P=.14). After The Wall Street Journal article, use of abdominal hysterectomy increased 1.1% per quarter for two quarters through the FDA warning (P<.001), plateaued for three quarters until March 2015 (P=.65), then decreased by 0.8% per quarter through 2016 (P<.001). Supracervical hysterectomy volume continuously decreased after the FDA warning (1.0% decrease per quarter, P<.001) and after three quarters (0.7% decrease per quarter, P=.01), then plateaued from April 2015 through 2016 (0.05% decrease per quarter, P=.40). Mode of supracervical hysterectomy was unchanged from 2012 to 2013 (P=.43), followed by two quarters of significant increase in proportion of supracervical abdominal hysterectomies (11.7%/quarter, P<.001). This change in mode of supracervical hysterectomy then plateaued through 2016 (P=.06).
CONCLUSION
Despite early studies suggesting that minimally invasive hysterectomy decreased in response to safety concerns regarding power morcellation, we found that this effect reversed 1 year after the FDA safety communication. However, there was a sustained decline in supracervical hysterectomy, and the remaining supracervical hysterectomies were more likely to be performed using laparotomy.
Topics: Adult; Female; Humans; Hysterectomy; Laparoscopy; Laparotomy; Middle Aged; Minimally Invasive Surgical Procedures; Morcellation; Quality Improvement; United States; United States Food and Drug Administration
PubMed: 30870280
DOI: 10.1097/AOG.0000000000003181 -
Fertility and Sterility Apr 2015To demonstrate 2 step-by-step techniques for contained morcellation of uterine tissue.
OBJECTIVE
To demonstrate 2 step-by-step techniques for contained morcellation of uterine tissue.
DESIGN
Instructional video showing laparoscopic electromechanical morcellation within an endoscopic pouch, and alternatively, tissue extraction via ultra-minilaparotomy.
SETTING
Academic medical center.
PATIENT(S)
Women undergoing laparoscopic myomectomy or hysterectomy.
INTERVENTION(S)
For contained electromechanical morcellation, the specimen is placed within an endoscopic pouch, the edges of which are exteriorized through a 15-mm cannula. The cannula is repositioned inside the pouch for insufflation. A bladed fixation trocar enters the pouch through an assistant port and is secured by its retention disk and balloon tip. Gas inflow is changed to this assistant port, through which the laparoscope is inserted. A power morcellator is introduced via the 15-mm port site, and morcellation thus proceeds within the containment system. Residual fragments of tissue are collectively retrieved by withdrawing the endoscopic pouch. For tissue extraction via ultra-minilaparotomy, the specimen is placed within a pouch that is drawn up through a flexible, self-retaining retractor seated in a 2 to 3-cm incision. The specimen is cored out sharply with a scalpel.
MAIN OUTCOME MEASURE(S)
None.
RESULT(S)
Contained morcellation is technically feasible, efficient (mean additional operative time is approximately 30 minutes), and prevents intraperitoneal dispersion of tissue fragments. Our group has safely performed >100 such procedures and removed specimens weighing nearly 1,500 grams. Potential complications include viscous injury upon insertion of the bladed trocar, and pouch failure.
CONCLUSION(S)
These techniques allow surgeons to adopt the new standard of contained morcellation and permit removal of extensive pathology with a minimally invasive approach.
Topics: Female; Humans; Hysterectomy; Laparoscopy; Specimen Handling; Uterine Myomectomy; Uterine Neoplasms; Uterus
PubMed: 25712576
DOI: 10.1016/j.fertnstert.2015.01.022 -
Obstetrics & Gynecology Science Mar 2018This study introduces and evaluates the feasibility, safety, and surgical outcomes of the in-bag power morcellation technique during single-port assisted (SPA)...
OBJECTIVE
This study introduces and evaluates the feasibility, safety, and surgical outcomes of the in-bag power morcellation technique during single-port assisted (SPA) laparoscopic myomectomy in comparison with manual scalpel morcellation.
METHODS
This is a retrospective review of a total of 58 patients who underwent SPA laparoscopic myomectomy employing in-bag power morcellation (n=27) or manual scalpel morcellation (n=31), performed between December 2014 and December 2016. Surgical outcomes, including total operation time, estimated blood loss, postoperative hemoglobin changes, postoperative hospital stay, postoperative pain (visual analog scale), perioperative and postoperative complications were evaluated.
RESULTS
The demographics and patient characteristics were similar between both groups. The median patient age was 34 years and median body mass index was 20.84 kg/m. The median specimen weight was 110 g. The median operating time was 138 minutes. The median estimated blood loss was 50 mL and the median postoperative hemoglobin change was 2.2 g/dL. The median postoperative hospital stay was 2 days and the median postoperative pain scores were 5 after 6 hours, 3 after 24 hours, and 2 after 48 hours. Occult malignancy was not identified in any patients. There were no intraoperative complications such as LapBag ruptures or gross spillage.
CONCLUSION
In-bag power morcellation for SPA laparoscopic myomectomy is feasible and safe, minimizing the risks of open power morcellation. There were also no statistically significant differences in surgical outcomes.
PubMed: 29564319
DOI: 10.5468/ogs.2018.61.2.267 -
Scientific Reports Aug 2016Uterine sarcoma, a rare solid tumor in uterus, is difficult to identify in the early stage from some benign uterine tumors, such as uterine fibroids. Hence, uterine... (Review)
Review
Uterine sarcoma, a rare solid tumor in uterus, is difficult to identify in the early stage from some benign uterine tumors, such as uterine fibroids. Hence, uterine sarcoma may be treated in the same way as uterine fibroids; and this may not be found until pathological diagnosis. Consequently, this can lead to tumor's abdominal spread, planting and local invasive growth, resulting in an early uterine sarcoma, an increased relapse rate after surgery and a decreased survival. Therefore, it's important to avoid these unintended and iatrogenic complications through an accurate diagnosis and an appropriate surgical approach. The surgical staging and a complete resection of the tumor are both important for patients' prognosis. In this review, we will discuss the laparoscopic surgery for uterine sarcoma in the early stage and patients' prognosis.
Topics: Disease Progression; Early Detection of Cancer; Female; Humans; Hysterectomy; Laparoscopy; Leiomyoma; Morcellation; Neoplasm Invasiveness; Neoplasm Metastasis; Neoplasm Recurrence, Local; Prognosis; Quality of Life; Sarcoma; Uterine Neoplasms
PubMed: 27503773
DOI: 10.1038/srep31229 -
Seminars in Plastic Surgery May 2015Gynecomastia refers to the enlargement of the male breast due to a proliferation of ductal, stromal, and/or fatty tissue. Although it is a common condition affecting up...
Gynecomastia refers to the enlargement of the male breast due to a proliferation of ductal, stromal, and/or fatty tissue. Although it is a common condition affecting up to 65% of men, not all cases require surgical intervention. Contemporary surgical techniques in the treatment of gynecomastia have become increasingly less invasive with the advent of liposuction and its variants, including power-assisted and ultrasound-assisted liposuction. These techniques, however, have been largely limited in their inability to address significant skin excess and ptosis. For mild to moderate gynecomastia, newer techniques using arthroscopic morcellation and endoscopic techniques promise to address the fibrous component, while minimizing scar burden by utilizing liposuction incisions. Nevertheless, direct excision through periareolar incisions remains a mainstay in treatment algorithms for its simplicity and avoidance of additional instrumentation. This is particularly true for more severe cases of gynecomastia requiring skin resection. In the most severe cases with significant skin redundancy and ptosis, breast amputation with free nipple grafting remains an effective option. Surgical treatment should be individualized to each patient, combining techniques to provide adequate resection and optimize aesthetic results.
PubMed: 26528088
DOI: 10.1055/s-0035-1549053 -
PloS One 2016Laparoscopic myomectomy is a minimally invasive, conservative surgical approach commonly used for the treatment of uterine fibroids. However, there is a lack of...
Laparoscopic myomectomy is a minimally invasive, conservative surgical approach commonly used for the treatment of uterine fibroids. However, there is a lack of effective means to distinguish the nature of uterine tumors prior to surgery. The impact of fibroid morcellation during laparoscopic surgery on the dissemination of cancerous uterine fibroids and long-term survival of patients has gained increasing attention. A retrospective cohort study was conducted to analyze the impact of different surgical approaches on recurrence-free survival (RFS) and overall survival (OS) in patients with a postoperative pathological diagnosis of uterine sarcoma at a single medical center. Patients who underwent the first surgery for uterine fibroids (confined to the uterus) and had a postoperative pathological diagnosis of uterine sarcoma were selected in the Chinese PLA General Hospital from January 2005 to January 2014. Based on the use of fibroid morcellation, the subjects were divided into fibroid morcellation (FM) and total hysterectomy (TH, non-morcellation) groups. Follow-up outcomes, including RFS and OS times, were observed. In total, 59 patients were included, with 30 cases in the FM group and 29 cases in the TH group. There were no significant differences in RFS and OS time between the two groups (RFS: P = 0.16, OS: P = 0.09). Multivariate correlation analysis showed that the impact of a higher grade level on RFS and OS was nearly 2-fold the impact of a lower grade level (RFS: P = 0.04, odds ratio (OR) = 1.97; OS: P = 0.03, OR = 2.29). Intraoperative morcellation, postoperative adjuvant therapy, age, tumor size, FIGO stage, and surgical approach were not risk factors affecting RFS and OS. Fibroid morcellation during laparoscopic surgery (including laparoscopic, transvaginal and transabdominal approaches) had no significant impact on RFS and OS time in patients. However, the 5-year RFS and OS rates were both lower in the FM group than in the TH group. Grade level was a significant risk factor for the prognosis of patients with uterine sarcoma.
Topics: Disease-Free Survival; Female; Humans; Hysterectomy; Laparoscopy; Leiomyoma; Middle Aged; Morcellation; Multivariate Analysis; Retrospective Studies; Sarcoma; Survival Analysis; Time Factors; Uterine Myomectomy; Uterine Neoplasms
PubMed: 26828206
DOI: 10.1371/journal.pone.0148050 -
Journal of Obstetrics and Gynaecology... Dec 2015Uterine morcellation of presumed leiomyomas inadvertently results in an increase in morcellated uterine leiomyosarcoma (ULMS). Morcellation alters the natural course of...
OBJECTIVES
Uterine morcellation of presumed leiomyomas inadvertently results in an increase in morcellated uterine leiomyosarcoma (ULMS). Morcellation alters the natural course of ULMS, leading to an increased incidence and earlier recurrences. Recurrences following tumor morcellation are significantly more likely to occur in the peritoneum. Since there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the US FDA (Food and Drug Administration) discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy (US Food and Drug Administration, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm in 2014). In the wake of recent ban on usage of power morcellation by US FDA, we introduce a technique of in-bag morcellation, thus avoiding spillage of tissues in the peritoneal cavity and spread of an undiagnosed disease or cancer or sarcoma.
METHODS
We present a study of twenty-one cases of laparoscopic in-bag morcellation of fibroid and uteri done by Total Health Care method.
RESULTS
The in-bag morcellation technique handles the issue of ULMS and makes laparoscopic myomectomy and hysterectomy possible with fair safety.
CONCLUSIONS
Further studies should be directed toward identifying patients at high risk of ULMS prior to presumed leiomyoma resection in order to reduce the risk of inadvertent tumor morcellation.
PubMed: 26663999
DOI: 10.1007/s13224-015-0795-5 -
Investigative and Clinical Urology Jul 2023To determine the factors affecting morcellation efficiency in holmium laser enucleation of the prostate (HoLEP) surgery.
PURPOSE
To determine the factors affecting morcellation efficiency in holmium laser enucleation of the prostate (HoLEP) surgery.
MATERIALS AND METHODS
Patients who underwent HoLEP surgery by a single surgeon between 2018 and 2022 were included in the study. Our primary outcome of interest in this study was morcellation efficiency. The effect of preoperative and perioperative variables on morcellation efficiency was evaluated with linear regression analysis.
RESULTS
A total of 410 patients were included in the study. The mean morcellation efficiency was 6.95±1.70 g/min. Univariable and multivariable linear regression analysis was performed to identify factors affecting morcellation efficiency. Presence of the "beach ball" effect (small, round prostatic tissue fragments that are fibrotic and difficult to morcellate), the learning curve, resectoscope sheath type, prostate-specific antigen (PSA) density, morcellated tissue weight, and the presence of prostate calcification were found to be independent predictive factors (β=-1.107, 95% CI: -1.59 to -0.55, p<0.001; β=-0.514, 95% CI: -0.85 to -0.17, p=0.003; β=-0.394, 95% CI: -0.65 to -0.13, p=0.003; β=-0.302, 95% CI: -0.59 to -0.09, p=0.043; β=0.062, 95% CI: 0.05 to 0.06, p<0.001; β=-0.329, 95% CI: -0.55 to -0.10, p=0.004; respectively).
CONCLUSIONS
This study reports that presence of the beach ball effect, the learning curve, small resectoscope sheath, PSA density, and presence of prostate calcification negatively affect morcellation efficiency. On the contrary, morcellated tissue weight has a linear relationship with morcellation efficiency.
Topics: Male; Humans; Prostate; Prostatic Hyperplasia; Holmium; Morcellation; Lasers, Solid-State; Prostate-Specific Antigen; Retrospective Studies; Treatment Outcome
PubMed: 37417564
DOI: 10.4111/icu.20220361 -
Scientific Reports Oct 2021Electromechanical morcellation-so called power morcellation-is a minimally invasive approach to remove bulky lesions such as uterine fibroids. The spread of benign and...
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.
Topics: Female; Humans; Hysterectomy; Laparoscopy; Leiomyoma; Morcellation; Surgical Instruments; Uterus
PubMed: 34686761
DOI: 10.1038/s41598-021-99934-1 -
Archivos Espanoles de Urologia Oct 2020Prostate enucleation is becoming more relevant within BPH treatment. Nowadays is probably the gold standard for enucleation. Several studies have shown holmium laser as... (Review)
Review
OBJECTIVE
Prostate enucleation is becoming more relevant within BPH treatment. Nowadays is probably the gold standard for enucleation. Several studies have shown holmium laser as the most frequently used safe and efficient energy source. The long learning curve remains as its major drawback. The current review aims to describe step to step technique at our institutionand describing the rational for its use.
METHODS
A detailed description on our step-to-step Holep technique is provided. We focused on the main differences with other techniques already described highlighting the largest experience reported.
RESULTS
None of the published series has shown better results in terms of functional, safety and less complications outcomes on the short and long term. No differences are shown in terms of intraoperative/postoperative blood loss, reoperations, capsular perforations or urethral strictures. Our techniques provides shorter surgical length and improved efficiency than blocking and trilobular techniques. The rates of early continence are 4% vs5-40%. Lastly, improvement in morcellator devices delivered no complications related to that part of the surgery.
CONCLUSIONS
Holep is the gold standard technique for prostate enucleation. It provides improved functional and safety outcomes than with other techniques. A standardized and optimized technique is mandatory.
Topics: Humans; Laser Therapy; Lasers, Solid-State; Male; Prostatic Hyperplasia; Urethral Stricture
PubMed: 33025915
DOI: No ID Found