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OBJECTIVE: To estimate the risk of uterine leiomyosarcoma in patients undergoing gynecological surgery and also to identify groups at risk for unrecognized uterine leiomyosarcoma. METHODS: A national cohort study was performed evaluating all uterine leiomyosarcoma (ULMS) diagnosed in The Netherlands between January 2000 and September 2015. Cases were identified and supplied by the nationwide network and registry of histo- and cytopathology in The Netherlands (PALGA). Unexpected and expected ULMS were compared. Approval for this study was granted by the Medical Ethics Committee of all participating hospitals and by the review board of PALGA. RESULTS: 262 original cases were included. The overall incidence of ULMS in our study was 0.25% or 1:400 patients. The incidence of unexpected ULMS was 0.12% or 1:865 patients. Preoperatively, a malignancy was unexpected in 46% of the cases and expected in 54%. Abnormal uterine bleeding constituted most of the symptoms. 90% of women underwent abdominal hysterectomy and/or bilateral salpingo-oophorectomy. CONCLUSIONS: Leiomyosarcoma are rare. Women aged 40-50 years with abnormal uterine bleeding are most at risk for unexpected ULMS. In contrast, this risk is low in postmenopausal women. ULMS were highly uncommon in women aged under 40 years.
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Leiomiosarcoma/epidemiología , Neoplasias Uterinas/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Procedimientos Quirúrgicos Ginecológicos , Humanos , Histerectomía , Incidencia , Laparoscopía , Leiomiosarcoma/cirugía , Persona de Mediana Edad , Países Bajos/epidemiología , Neoplasias Pélvicas/cirugía , Neoplasias Uterinas/cirugíaRESUMEN
BACKGROUND: To assess potential risks of new surgical procedures and devices before their introduction into daily practice, a prospective risk inventory (PRI) is a required step. This study assesses the applicability of the Health Failure Mode and Effects Analysis (HFMEA) as part of a PRI of new technology in minimally invasive gynecologic surgery. METHODS: A reference case was defined of a patient with presumed benign leiomyoma undergoing a laparoscopic hysterectomy or myomectomy including in-bag power morcellation; however, pathology defined a stage I uterine leiomyosarcoma. Using in-bag morcellation as a template, a HFMEA was performed. All steps of the in-bag morcellation technique were identified. Next, the possible hazards of these steps were explored and possible measures to control these hazards were discussed. RESULTS: Five main steps of the morcellation process were identified. For retrieval bags without openings to accommodate instruments inside the bag, 120 risks were identified. Of these risks, 67 should be eliminated. For containment bags with openings 131 risks were identified of which 68 should be eliminated. Of the 10 causes most at risk to cause spillage, two can be eliminated by using appropriate bag materials. Myomectomy appears to be more at risk for residual tissue spillage compared to total hysterectomy. CONCLUSION: The HFMEA has provided important new insights regarding potential weaknesses of the in-bag morcellation technique, particularly with respect to hazardous steps in the morcellation process as well as requirements that bags should meet. As such, this study has shown HFMEA to be a valuable method that identifies and quantifies potential hazards of new technology.
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Histerectomía/métodos , Laparoscopía/métodos , Leiomiosarcoma/cirugía , Morcelación/métodos , Miomectomía Uterina/métodos , Neoplasias Uterinas/cirugía , Femenino , Análisis de Modo y Efecto de Fallas en la Atención de la Salud , Humanos , Estudios ProspectivosRESUMEN
OBJECTIVES: To compare uterine-sparing treatment options for fibroids in terms of reintervention risk and quality of life. DESIGN: Systematic review and meta-analysis according to PRISMA guidelines. SETTING: Not applicable. PATIENT(S): Women with uterine fibroids undergoing a uterine-sparing intervention. INTERVENTIONS(S): Not applicable. MAIN OUTCOME MEASURE(S): 1) Reintervention risk after uterine-sparing treatment for fibroids after 12, 36, and 60 months; and 2) quality of life outcomes, based on validated questionnaires. Two separate analyses were performed for the procedures that used an abdominal approach (myomectomy, uterine artery embolization [UAE], artery ligation, high-intensity focused ultrasound [HIFU], laparoscopic radiofrequency ablation [RFA]) and for the procedures managing intracavitary fibroids (hysteroscopic approach, including hysteroscopic myomectomy and hysteroscopic RFA). RESULT(S): There were 85 articles included for analysis, representing 17,789 women. Stratified by treatment options, reintervention risk after 60 months was 12.2% (95% confidence interval [CI] 5.2%-21.2%) for myomectomy, 14.4% (95% CI 9.8%-19.6%) for UAE, 53.9% (95% CI 47.2%-60.4%) for HIFU, and 7% (95% CI 4.8%-9.5%) for hysteroscopy. For the other treatment options, no studies were available at 60 months. For quality of life outcomes, symptoms improved after treatment for all options. The HIFU procedure had the least favorable outcomes. CONCLUSION(S): Despite the substantial heterogeneity of the study population, this meta-analysis provides valuable information on relative treatment efficacy of various uterine-sparing interventions for fibroids, which is relevant when counseling patients in daily practice. Furthermore, this study demonstrates that long-term data, particularly for the newest uterine-sparing interventions, are urgently needed.
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Preservación de la Fertilidad/métodos , Leiomioma/terapia , Tratamientos Conservadores del Órgano/métodos , Complicaciones Posoperatorias/terapia , Calidad de Vida , Neoplasias Uterinas/terapia , Adulto , Femenino , Preservación de la Fertilidad/efectos adversos , Humanos , Leiomioma/patología , Persona de Mediana Edad , Tratamientos Conservadores del Órgano/efectos adversos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Retratamiento , Medición de Riesgo , Factores de Riesgo , Resultado del Tratamiento , Neoplasias Uterinas/patologíaRESUMEN
BACKGROUND: New technology should be extensively tested before it is tried on patients. Unfortunately representative models are lacking. In theory, fresh frozen human cadavers are excellent models. OBJECTIVE: To identify strengths and weaknesses of fresh frozen human cadavers as research models for new technology prior to implementation in gynecological surgery. METHODS: During pre-clinical validation studies regarding the MobiSep uterine manipulator, test procedures were performed on fresh frozen cadavers. Both the experimental setup as the performance of the prototype were assessed. RESULTS: Five tests including six human cadavers were performed. Major changes were made to the MobiSep prototype design. The cadavers of two tests closely resembled surgical experiences as found in live patients. The anatomy of 4 of the 6 cadavers was not fully representative due to atrophy of the internal genitalia caused by age and due to the presence of pathology such extensive tumorous tissue. CONCLUSION: The cadaver tests provided vital information regarding design and functionality, that failed to emerge during the in-vitro testing. However, experiments are subject to anatomical uncertainties or restrictions. Consequently, the suitability of a cadaver should be carefully assessed before it is used for testing new technology.
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Cadáver , Procedimientos Quirúrgicos Ginecológicos/educación , Procedimientos Quirúrgicos Mínimamente Invasivos/educación , Estudios de Factibilidad , Humanos , Laparoscopía/educaciónRESUMEN
OBJECTIVE: The aim of this study was to review musculoskeletal disorder (MSD) prevalence among surgeons performing minimally invasive surgery. BACKGROUND: Advancements in laparoscopic surgery have primarily focused on enhancing patient benefits. However, compared with open surgery, laparoscopic surgery imposes greater ergonomic constraints on surgeons. Recent reports indicate a 73% to 88% prevalence of physical complaints among laparoscopic surgeons, which is greater than in the general working population, supporting the need to address the surgeons' physical health. METHODS: To summarize the prevalence of MSDs among surgeons performing laparoscopic surgery, we performed a systematic review of studies addressing physical ergonomics as a determinant, and reporting MSD prevalence. On April 15 2016, we searched Pubmed, EMBASE, the Cochrane Library, Web of Science, CINAHL, and PsychINFO. Meta-analyses were performed using the Hartung-Knapp-Sidik-Jonkman method. RESULTS: We identified 35 articles, including 7112 respondents. The weighted average prevalence of complaints was 74% [95% confidence interval (95% CI) 65-83]. We found high inconsistency across study results (I = 98.3%) and the overall response rate was low. If all nonresponders were without complaints, the prevalence would be 22% (95% CI 16-30). CONCLUSIONS: From the available literature, we found a 74% prevalence of physical complaints among laparoscopic surgeons. However, the low response rates and the high inconsistency across studies leave some uncertainty, suggesting an actual prevalence of between 22% and 74%. Fatigue and MSDs impact psychomotor performance; therefore, these results warrant further investigation. Continuous changes are enacted to increase patient safety and surgical care quality, and should also include efforts to improve surgeons' well-being.
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Laparoscopía , Enfermedades Musculoesqueléticas/epidemiología , Enfermedades Profesionales/epidemiología , Cirujanos , Ergonomía , Humanos , PrevalenciaRESUMEN
STUDY OBJECTIVE: To assess features of power morcellators (blade diameter, circular vs oscillating cutting, blade rotation speed, experience level) regarding their effect on the amount of tissue spill. In addition, the amount of tissue spill after the initial two-thirds and final one-third of the morcellated specimen was evaluated. DESIGN: In vitro study (Canadian Task Force classification II-2). SETTING: Laparoscopic skills lab of an academic hospital. PATIENTS: Not applicable. INTERVENTION: Power morcellation of beef tongue specimens. MEASUREMENTS AND MAIN RESULTS: Twenty-four trials were performed. Morcellation was performed in 2 phases (phase 1: initial two-thirds of the total tissue; phase 2: last one-third of the tissue). With larger blade diameter a decline was observed in both the weight of the spilled particles (phase 1) and the number of spilled particles (phases 1 and 2 and both combined) (weight phase 1: 6.5 g vs 6.3 g vs 2.2 g for 12.5 mm vs 15 mm vs 20 mm, respectively, p = .04; number particles: phase 1, 10.2 vs 7.2 vs 2.7, p = .01; phase 2, 22.9 vs 19.0 vs 8.9, p = .02; total, 34.7 vs 26.2 vs 11.6, p = .01). Also, spinning of the tissue mass due to torque applied by the rotating blade occurred later when blade size increased, and the size of the spilled particles was larger (weight of morcellated tissue at onset of torque: 136 g vs 198 g vs 222 g, p = .07; size: .6 g vs .9 g vs .8 g, p = .1). In the oscillation mode there was less total spill (6.8 g/100 g vs 21.3 g/100 g, p = .01, for oscillation and circular cutting, respectively). CONCLUSION: The present study demonstrates that less spill is created by power morcellators with an oscillating blade and/or a large diameter (≥20 mm). Furthermore, when using a large-diameter blade the spilled particles are larger, and less morcellation repetitions are needed. By combining these features with currently introduced contained morcellation, the safety of the morcellation process with respect to tissue spill can be further improved.
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Laparoscopía , Procedimientos Quirúrgicos Mínimamente Invasivos , Lengua/patología , Animales , Bovinos , Modelos Animales de Enfermedad , Humanos , Técnicas In Vitro , Laparoscopía/métodos , Tamaño de los ÓrganosRESUMEN
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 April 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.
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STUDY OBJECTIVE: To assess the basic morcellation process in laparoscopic supracervical hysterectomy (LSH). Proper understanding of this process may help enhance future efficacy of morcellation regarding the prevention of tissue scatter. DESIGN: Time-action analysis was performed based on video imaging of the procedures (Canadian Task Force classification II-2). SETTING: Procedures were performed at Leiden University Medical Centre and St Lucas Andreas Hospital, Amsterdam, the Netherlands. PATIENTS: Women undergoing LSH for benign conditions. INTERVENTIONS: Power morcellation of uterine tissue. MEASUREMENTS AND MAIN RESULTS: The morcellation process was divided into 4 stages: tissue manipulation, tissue cutting, tissue depositing, and cleaning. Stages were timed, and perioperative data were gathered. Data were analyzed as a whole and after subdivision into 3 groups according to uterine weight: <350 g, 350 to 750 g, and >750 g. A cutoff point was found at a uterine weight of 350 g, after which an increase in uterine weight did not affect the cleaning stage. The tissue strip cutting time was used as a measure for tissue strip length. With progression of the morcellation process, the tissue strip cutting time decreases. The majority of cutting time is of short duration (i.e., 60% of the cutting lasts 5 seconds or less), and these occur later on in the morcellation process. CONCLUSION: With the current power morcellators, the amount of tissue spread peaks and is independent of uterine weight after a certain cutoff point (in this study 350 g). There is a relative inefficiency in the rotational mechanism because mostly small tissue strips are created. These small tissue strips occur increasingly later on in the procedure. Because small tissue strips are inherently more prone to scatter by the rotational mechanism of the morcellator, the risk of tissue spread is highest at the end of the morcellation procedure. This means that LSH and laparoscopic hysterectomy procedures may be at higher risk for tissue scatter than total laparoscopic hysterectomy. Finally, engineers should evaluate how to create only large tissue strips or assess alternatives to the rotational mechanism.
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Histerectomía/métodos , Laparoscopía , Miomectomía Uterina/instrumentación , Útero/patología , Adulto , Femenino , Humanos , Histerectomía/instrumentación , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos , Países Bajos , Tamaño de los Órganos , Guías de Práctica Clínica como Asunto , Estudios Prospectivos , Análisis y Desempeño de Tareas , Resultado del TratamientoRESUMEN
Hysterectomy is still one of the most frequently performed gynaecological procedures. The use of the laparoscopic approach has increased over recent years and a shift in indication has been observed. However, not every clinic or gynaecologist is able to provide laparoscopic hysterectomy for more challenging patients. Therefore, referral to an expert centre is of the highest importance in order to offer the patient the least invasive approach to hysterectomy. The advantages of the laparoscopic approach have become more evident over recent years. The widespread introduction of minimally invasive surgery means that surgeons are encountering new challenges, such as the rapid introduction of new instruments, the absolute increased incidence of rare complications and the provision of post-operative counselling on recovery. Maintaining knowledge of these matters is essential in order to secure the quality of care.
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Procedimientos Quirúrgicos Ginecológicos/tendencias , Histerectomía/métodos , Laparoscopía/métodos , Índice de Masa Corporal , Femenino , Humanos , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos , Medición de RiesgoRESUMEN
OBJECTIVES: Standard treatment in early-stage cervical cancer is a radical hysterectomy (RH) with pelvic lymphadenectomy. In women who wish to preserve fertility radical vaginal trachelectomy has been proposed; however, this is not feasible in larger tumors, and nerve-sparing surgery is not possible. Nerve-sparing radical abdominal trachelectomy (NSRAT) overcomes these disadvantages. METHODS: Case-control study of women with early-stage cervical cancer (International Federation of Gynecology and Obstetrics IA2-IB) submitted to NSRAT from 2000 until 2011. Women submitted to nerve-sparing RH with early-stage cervical cancer were included as control subjects. RESULTS: Twenty-eight patients and 77 control subjects were included. Neoadjuvant chemotherapy was administered in 3 women before NSRAT because the linear extension was or exceeded 40 mm. Local recurrence rate was 3.6% (95% confidence interval [CI], 0.00-10.6) in the NSRAT group compared with 7.8% (95% CI, 1.7-13.9) in the control group (P = 0.44). No significant difference was found between both groups regarding disease-free survival and survival. The overall pregnancy rate was 52.9% (95% CI, 28.7%-77.2%). The mean follow-up was 47.3 months (range, 6-122 months) for NSRAT and 51.8 months (11-129.6 months) for nerve-sparing RH. CONCLUSIONS: Nerve-sparing radical abdominal trachelectomy seems safe and effective in women with early-stage cervical cancer who wish to preserve fertility. Respective women should be informed about this treatment option, especially if the tumor is too large for radical vaginal trachelectomy.