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1.
J Obstet Gynaecol Res ; 49(2): 682-690, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36345574

RESUMO

AIM: Laparoscopic power morcellator (LPM) can be used for tissue retrieval through laparoscopic port site, but the dissemination of uterine and/or myoma tissues is a serious complication. To study the use of LPM for uterine fibroid treatment in Japan, we aimed to perform two national cross-sectional surveys comprising multiple questionnaires. METHODS: The first survey (2011-2013) was conducted in November 2014, and 203 medical institutions responded. The second survey (2017-2019) was conducted in December 2020, and 302 medical institutions were investigated. RESULTS: Overall, 72 104 and 120 425 surgeries and 0.04% and 0.05% cases of postoperative malignancy diagnosis were reported in the first and second surveys, respectively. Magnetic resonance imaging was performed in >90% of the cases in the first and second surveys as preoperative examinations. The frequency of LPM at hysterectomy was 8.9% and 4.6% and the frequency of LPM at laparoscopic myomectomy was 80.4% and 54.8% in the first and second surveys, respectively; both the parameters decreased in the second survey. CONCLUSIONS: It is impossible to completely exclude malignant diseases even if extensive preoperative diagnosis has been done before surgery. Therefore, the use of LPM in patients requires careful attention and informed consent in Japan.


Assuntos
Laparoscopia , Leiomioma , Miomectomia Uterina , Neoplasias Uterinas , Feminino , Humanos , Neoplasias Uterinas/cirurgia , Neoplasias Uterinas/patologia , Estudos Transversais , Leiomioma/cirurgia , Leiomioma/patologia , Miomectomia Uterina/métodos , Laparoscopia/métodos , Inquéritos e Questionários
2.
Minim Invasive Ther Allied Technol ; 32(6): 323-328, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37493491

RESUMO

OBJECTIVE: Proposing hysteroscopic morcellation (HM) as a surgical-therapeutic approach in the treatment of retained products of conception (RPOC) to prevent intrauterine adhesions (IUAs). DESIGN: Prospective analysis. SETTING: A teaching and university hospital. PATIENTS: Women with RPOC. INTERVENTIONS: Office -HM with 'Truclear 5 C'. MATERIAL AND METHODS: Twenty-two consecutive patients presenting with trophoblastic residue retention after miscarriage and interruption of pregnancy or placenta remnants after cesarean section or delivery were enrolled. These women underwent office-HM with 'Truclear 5 C'. Primary outcomes were median time and rate of hospitalization. The quality of the specimen was also analyzed. A hysteroscopic second look for IUAs was performed. RESULTS: Mean procedure time was six minutes (SD ± 5). Tissue samples had a mean collection size 2.5 cm3+0.9. 38% of the samples had spotting or abnormal vaginal discharge. Dilatation of the cervical canal was not performed in any case. Second-look hysteroscopy did not show any de novo IUAs in any of the enrolled patients. CONCLUSIONS: In the hysteroscopic treatment of RPOC, HM is a valid choice in an office setting without the use of cervical dilatation. Removal of RPOC was uneventful in all cases, simple and carried out faster without any adverse outcomes.


Assuntos
Morcelação , Complicações na Gravidez , Doenças Uterinas , Gravidez , Humanos , Feminino , Cesárea , Complicações na Gravidez/etiologia , Complicações na Gravidez/cirurgia , Doenças Uterinas/cirurgia , Histeroscopia/efeitos adversos , Estudos Retrospectivos
3.
J Minim Invasive Gynecol ; 28(11): 1860-1867, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-33951488

RESUMO

STUDY OBJECTIVE: To evaluate initial feasibility and experience with guided hysteroscopic morcellation for uterine evacuation of early miscarriage. DESIGN: A prospective pilot study of 10 cases. SETTING: A tertiary university hospital in Israel. PATIENTS: Women with confirmed early miscarriage at a gestational age of below 10 weeks from the last menstrual period. INTERVENTIONS: From May 2020 to October 2020, the hysteroscopic TruClear tissue removal system (Medtronic, Minneapolis, MN) was used for evacuation of early miscarriage in 10 women. The procedures were recorded. MEASUREMENTS AND MAIN RESULTS: Data including the length of the procedure, visibility, complete evacuation, bleeding, complications, and follow-up ultrasonography (US) were recorded. The mean duration of the procedure was 24 minutes. Complete evacuation was recorded in all cases. No adverse events were recorded in any of the 10 procedures. Normal uterine cavity without evidence of retained products of conception was documented in follow-up evaluation by US in all cases. Four patients underwent a follow-up office hysteroscopy that demonstrated a normal cavity without evidence of adhesions. In 4 cases (40%), an additional suction curettage was performed immediately after the hysteroscopic procedure owing to obscured visibility or an abnormal US scan at the end of the procedure. However, retained products of conception were found in only 1 of these 4 suction specimens (25%). CONCLUSION: Hysteroscopic morcellation under vision seems to be a safe and feasible technique for management of early missed abortion. This method may have potential as an innovative treatment of miscarriage in selected cases. Further studies are needed to refine the indications and the surgical technique.


Assuntos
Aborto Espontâneo , Morcelação , Aborto Espontâneo/cirurgia , Feminino , Humanos , Histeroscopia , Lactente , Projetos Piloto , Gravidez , Estudos Prospectivos
4.
J Minim Invasive Gynecol ; 28(4): 801-810, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32681995

RESUMO

STUDY OBJECTIVE: To compare a reusable hysteroscopic morcellator and standard resectoscopes in the hysteroscopic management of uterine polyps. DESIGN: Single-center randomized prospective single-blind trial (resectoscope-morcellator study). SETTING: Centre Médico-chirurgical Obstétrique teaching hospital, Strasbourg University Hospitals, France. PATIENTS: All patients presenting with a single endometrial polyp of size 1 cm or larger. INTERVENTIONS: After consent, the patients were randomized into 2 groups: hysteroscopic morcellation (HM) group or standard resection (SR) group. Office-based review hysteroscopy was performed 6 weeks to 8 weeks after surgery. Primary end point: time of morcellation or resection. SECONDARY OUTCOMES: total operating time (minutes), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (visual analog scale: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (visual analog scale), and length of hospitalization. At review hysteroscopy, we noted whether the resection or morcellation had been effective and if synechiae were present or absent. Statistical analyses followed Bayesian methods. MEASUREMENTS AND MAIN RESULTS: Ninety patients were randomized: 45 in the HM group and 45 in the SR group. The average size of polyps at hysteroscopy was 13.3 mm. Morcellation time was lower than resection time (6.1 minutes vs 9 minutes; p [HM < SR] = .996). This also applied to total operating time (12.7 minutes vs 15.6 minutes; p [HM < SR] = .985), number of device insertions (1.50 vs 6; p [HM < SR] > .999), volume of fluid used (766.9 mL vs 1118.9 mL; p [HM < SR] = .994), and fluid deficit (60.2 mL vs 169.8 mL; p [HM < SR] = .989). Operator comfort was better in the HM group (8.4 vs 7.4; p [HM > SR] = .999) as was visualization (4 vs 3.7; p [HM > SR] = .911, highly probable). Operative complications were higher in the SR group (5 vs 0; p [HM < SR] = .989]. One patient in the SR group died after surgery owing to an anesthetic complication (anaphylactic shock complicated by pulmonary embolism). No differences were noted between the groups for pain assessment, length of hospitalization, and outcome on review hysteroscopy. CONCLUSION: The reusable morcellator is quicker, uses less fluid with less deficit and fewer introductory maneuvers, and offers better comfort and visualization than the resectoscope while being as effective for the hysteroscopic treatment of uterine polyps.


Assuntos
Pólipos , Neoplasias Uterinas , Teorema de Bayes , Feminino , Humanos , Histeroscopia , Pólipos/cirurgia , Gravidez , Estudos Prospectivos , Método Simples-Cego
5.
J Minim Invasive Gynecol ; 28(4): 788-793, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32681994

RESUMO

STUDY OBJECTIVE: The objective of this study was to determine the incidence of occult uterine malignancy at the time of sacrocolpopexy with concurrent hysterectomy, in the context of practice pattern changes as a result of the 2014 Food and Drug Administration (FDA) power morcellation safety communication. DESIGN: Retrospective chart review. SETTING: Tertiary care referral center in the United States. PATIENTS: A total of 839 patients who underwent sacrocolpopexy from January 2004 to December 2018. INTERVENTIONS: All patients received a concurrent hysterectomy without a diagnosis of suspected or confirmed gynecologic malignancy before surgery. Trends of surgeries were compared before and after the 2014 FDA power morcellation safety communication. MEASUREMENTS AND MAIN RESULTS: Demographic and perioperative data were collected from the system-wide electronic medical record. Operative and pathology reports were reviewed to determine the method of specimen retrieval and specimen pathology results. A total of 238 patients (28.4%) had a hysterectomy at the time of sacrocolpopexy. There were no cases of occult uterine malignancy (0%, 95% CI 0%-1.6%). There was 1 case of borderline tumor of the ovary. The most common mode of hysterectomy over the 15-year period was laparoscopic hysterectomy (n = 84, 35.3%), followed by vaginal hysterectomy (n = 63, 26.5%). After the FDA communication, the most common form of hysterectomy changed significantly to vaginal hysterectomy (n = 35, 55.6%; p <.001). When comparing the first 2 years after the announcement (2014-2016) to the subsequent 2 years (2017-2018), there was again a significant increase in the use of laparoscopic hysterectomy in the latter time period (7.3% vs 40.9%; p <.001). CONCLUSION: In this cohort of patients undergoing sacrocolpopexy with concurrent hysterectomy, the incidence of occult uterine malignancy was low. After the FDA safety communication, practice patterns with regard to the mode of hysterectomy changed, but the magnitude of these changes were transient.


Assuntos
Laparoscopia , Morcelação , Neoplasias Uterinas , Comunicação , Feminino , Humanos , Histerectomia/efeitos adversos , Laparoscopia/efeitos adversos , Morcelação/efeitos adversos , Estudos Retrospectivos , Estados Unidos/epidemiologia , United States Food and Drug Administration , Neoplasias Uterinas/epidemiologia , Neoplasias Uterinas/cirurgia
6.
BMC Surg ; 20(1): 77, 2020 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-32303216

RESUMO

BACKGROUND: Evaluate the safety and effectiveness of using an endoscopic tissue morcellator (ETM) to remove the retroperitoneal fat during retroperitoneoscopic radical nephrectomy (RRN). METHODS: The use of ETM in the removal of retroperitoneal fat was retrospectively analyzed in patients who underwent RRN for localized renal cancer in our hospital from January 2010 to January 2018. We accrued the appropriate patients and divided them into two groups. The first group included patients of RRN where ETM was used to remove the retroperitoneal fat, while the second group was comprised of patients of RRN where ETM was not performed, which served as the control group. Each group was further divided into two subgroups, including obese patients (BMI ≥ 28) and patients suffering from high-volume renal cancer (Stage T2a). The differences between the two groups as well as their subgroups were analyzed and statistically compared. RESULTS: All 222 nephrectomies were completed under retroperitoneoscopy, ETM was used in 105 of these 222 patients. Among them, 31 cases were of obese patients, and 26 cases were of high-volume renal cancer patients. The other 117 patients had undergone RRN without the use of ETM. Among them, 36 cases were of obese patients, and 28 cases were of high-volume renal cancer patients. The differences in age, BMI, tumor position, and tumor size between the two groups were not statistically significant, P > 0.05. Both the surgical time and the blood loss for the ETM group were significantly lower than the control group, p < 0.05. In the subgroup analysis, the obese patients and patients with high tumor volume also showed a significantly lower surgical time and less blood loss, p < 0.05. The postoperative hospitalization time, the total survival rate, and the disease-free survival rate were not statistically significant, p > 0.05. CONCLUSIONS: The use of ETM in removing the retroperitoneal fat during the RRN can potentially reduce the surgical time and lessen the blood loss. This technique is especially advantageous for obese and large-volume tumor patients.


Assuntos
Gordura Intra-Abdominal/cirurgia , Neoplasias Renais/cirurgia , Nefrectomia/métodos , Obesidade/epidemiologia , Idoso , Feminino , Humanos , Rim/patologia , Neoplasias Renais/patologia , Laparoscopia/métodos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Espaço Retroperitoneal , Estudos Retrospectivos
7.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(1): 72-74, 2019 Jan 30.
Artigo em Zh | MEDLINE | ID: mdl-30770698

RESUMO

With the development of minimally invasive surgery, many open surgery has been replaced by intracavity surgery. In laparoscopic surgery, an electric fibroid morcellator must be used to remove large tissue specimens from a small abdominal incision. Of course, there are some complications in the use, in order to follow the principle of no tumor, the doctor used the laparoscopic pouch in clinical operation to reduce the risk of spreading potential tumor tissue. There are various kinds of pouches, which are classified according to their existing state before use, it can be classified into two categories:overlapping and non-overlapping. The advantages and disadvantages of different bags and pockets are also analyzed. It provides a theoretical basis for technological innovation and equipment improvement.


Assuntos
Laparoscopia , Procedimentos Cirúrgicos Minimamente Invasivos , Laparoscopia/instrumentação
8.
AJR Am J Roentgenol ; 211(6): 1405-1415, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30354268

RESUMO

OBJECTIVE: The purpose of this article is to provide background on the epidemiologic, clinical, and economic impact of uterine leiomyomas, summarize the concerns associated with treating women with potential occult leiomyosarcomas (LMSs), and review the known and emerging imaging features of typical and atypical leiomyomas and explain how to differentiate them from LMSs. CONCLUSION: Surgical management of presumed benign uterine leiomyomas received popular media attention when a case of disseminated LMS occurred after laparoscopic power morcellator-assisted hysterectomy. A subsequent U.S. Food and Drug Administration review found a higher prevalence of unsuspected uterine sarcoma and LMS among patients undergoing myomectomy or hysterectomy for presumed benign leiomyomas than was previously reported. This heightened concern has led to increased pressure on radiologists to distinguish LMSs from leiomyomas.


Assuntos
Leiomioma/diagnóstico por imagem , Leiomiossarcoma/diagnóstico por imagem , Imageamento por Ressonância Magnética , Neoplasias Uterinas/diagnóstico por imagem , Diagnóstico Diferencial , Feminino , Humanos , Histerectomia , Leiomiossarcoma/cirurgia , Neoplasias Uterinas/cirurgia
9.
Neurourol Urodyn ; 36(3): 798-802, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-27128776

RESUMO

AIMS: Laparoscopic sacral colpopexy (LSC) for pelvic prolapse is a complex procedure, characterized by long operative times and, when combined with supracervical hysterectomy, by a high risk of spreading of unsuspected cancerous tissue. The aim of the present study was to compare, in patients who underwent hysterectomy plus LSC for severe POP, different methods for cervical incision and uterine morcellation. METHODS: This is a prospective single Institution randomized double-blinded clinical trial enrolling 124 patients with severe POP from June 2014 to May 2015. Patients underwent laparoscopic supracervical hysterectomy (LSH) plus LSC for pelvic organ prolapse and were randomized in Group 1 (monopolar hook and conventional mechanical morcellator) and Group 2 (bipolar laparoscopic loop and bipolar morcellator), for supracervical incision and uterine morcellation, respectively. Our primary endpoints were the operative times and the secondary endpoints the incidence of intra- or post-operative complications. RESULTS: A total of 50 patients for group completed the study. Baseline characteristics were similar between the groups. Cervical cutting time (32 vs. 3.10 sec; P <0.01), morcellation (4.10 vs. 2.13 min; P <0.01) and operative time (131 vs. 118 min; P <0.05) resulted significantly lower in Group 2. No differences were found in terms of intra- or post-operative complications. CONCLUSIONS: Laparoscopic bipolar loop and morcellator guaranteed a faster and hemostatic tool during supracervical incision and a controlled and rotation-free uterine extraction. The significant surgical time reduction linked to these devices should be considered even more helpful and effective to perform a complex procedure represented by LSH plus LSC. Neurourol. Urodynam. 36:798-802, 2017. © 2016 Wiley Periodicals, Inc.


Assuntos
Histerectomia/métodos , Laparoscopia/métodos , Idoso , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Duração da Cirurgia , Prolapso de Órgão Pélvico , Resultado do Tratamento
10.
J Gynecol Surg ; 32(6): 318-323, 2016 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-27965523

RESUMO

Background: Hysteroscopic morcellation removes uterine pathology under direct visualization with continuous real-time tissue fragment removal. Objective: The aim of this study was to explore the feasibility of hysteroscopic morcellation across a diverse set of facilities, including both surgical and office-based settings. Design: This was a prospective, single-arm, multicenter registry development (Canadian Task Force classification II-3). Materials and Methods: Thirty-four U.S. obstetrics and gynecology facilities enrolled subjects into the registry. Inclusion criteria were women ages 18-65 with indications for hysteroscopic myomectomy and/or polypectomy who were treated with the MyoSure® Hysteroscopic Tissue Removal System (Hologic Inc., Marlborough, MA). Intrauterine lesion type/size and removal parameters, adverse events (AEs), and physician satisfaction ratings were recorded. Results: A total of 559 pathologies (187 fibroids; 372 polyps) were removed from 278 registered subjects (mean age: 43.9 ± 9.0 years), with 250 procedures (89.9%) performed in an ambulatory surgery center or hospital outpatient setting and 28 (10.1%) in a gynecologic office setting. Most patients (n = 206, 74.1%) were treated for abnormal uterine bleeding, and 42 (15.1%) were treated for infertility. Mean fibroid diameter was 2.2 ± 1.2 cm. Mean polyp diameter was 1.3 ± 1.0 cm. Overall mean percentage of pathology removed was 95.4% (polyps 99.3%, fibroids 86.8%). Five AEs included four incidents of blunt cervical trauma and a single postoperative case of pedal edema; all were considered mild and resolved spontaneously. Postprocedure surveys indicated that 95% of reporting physicians were "satisfied" or "highly satisfied" with device performance. Conclusions: Hysteroscopic morcellation of intrauterine pathology was accomplished safely with a high degree of physician satisfaction in 278 patients treated in diverse healthcare settings that are reflective of general community practice in the United States. (J GYNECOL SURG 32:318).

11.
Gynecol Oncol ; 137(1): 167-72, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25462199

RESUMO

OBJECTIVE: To review the current evidence on the effects of intra-abdominal morcellation on survival outcomes of patients affected by unexpected uterine leiomyosarcoma (ULMS) and to estimate the risk of recurrence in those patients. METHODS: PubMed (MEDLINE), Scopus, Embase, Web of Science databases as well as ClinicalTrials.gov, were searched for data evaluating the effects of intra-abdominal morcellation on survival outcomes of patients with undiagnosed ULMS. Studies were evaluated per the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) and the American College of Obstetricians and Gynecologists (ACOG) guidelines. RESULTS: Sixty manuscripts were screened, 11 (18%) were selected and four (7%) were included. Overall, 202 patients were included: 75 (37%) patients had morcellation of ULMS, while 127 (63%) patients had not. A meta-analysis of these studies showed that morcellation increased the overall (62% vs. 39%; OR: 3.16 (95% CI: 1.38, 7.26)) and intra-abdominal (39% vs. 9%; OR: 4.11 (95% CI: 1.92, 8.81)) recurrence rates as well as death rate (48% vs. 29%; OR: 2.42 (95% CI: 1.19, 4.92)). No between-group difference in cumulative extra-abdominal recurrence (OR: 0.34 (95% CI: 0.07, 1.59)) rate was observed. CONCLUSIONS: Our data support a significant correlation between uterine morcellation and an increased risk of intra-abdominal recurrence in patients affected by unexpected ULMS. However, the limited data on this issue and the absence of high level of evidence suggest the need of further studies designed to estimate the risk to benefit ratio of morcellation in patients with uterine fibroids and undiagnosed ULMS.


Assuntos
Leiomiossarcoma/patologia , Leiomiossarcoma/cirurgia , Recidiva Local de Neoplasia/patologia , Inoculação de Neoplasia , Neoplasias Uterinas/patologia , Neoplasias Uterinas/cirurgia , Feminino , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Taxa de Sobrevida , Resultado do Tratamento
12.
Surg Endosc ; 29(11): 3414-21, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25552235

RESUMO

BACKGROUND: Laparoscopic hepatectomy (LH) using many different surgical techniques has become increasingly popular for the management of hepatic tumors. The performance of surgical procedures involving the least possible impairment is expected increasingly more often by both surgeons and patients. We herein describe a clinical cohort of ten patients with hepatic cavernous hemangioma (HCH) who underwent modified LH (MLH) with a new technique. We herein present the advantages of the low level of impairment during performance of this modified procedure and compare the outcomes of MLH with those of traditional LH (TLH) for HCH. METHODS: We retrospectively evaluated the treatment outcomes in 24 patients with HCH who underwent MLH (n = 10) or TLH (n = 14) from February 2008 to January 2013. Their demographic, intraoperative, and postoperative variables were compared. RESULTS: MLH was successful in all patients. An electromechanical morcellator allowed for easy extraction of the entire HCH without the use of a cumbersome retrieval bag, enlarged incision, or hand-assisted incision. There was no conversion to an open operation or significant perioperative complications. The operation time (P = 0.037), time to removal of the HCH (P < 0.0001), visual analog scale pain score on the first postoperative day (P = 0.012), time to off-bed activity (P = 0.036), and postoperative hospital stay (P = 0.048) were significantly lower in the MLH group than in the TLH group. CONCLUSIONS: MLH involving the use of an electromechanical morcellator provides expedient recovery and minimal postoperative pain and scarring. It is a feasible, effective, and safe surgical procedure and embodies all of the benefits of minimally invasive surgery for patients with HCH.


Assuntos
Hemangioma Cavernoso/cirurgia , Hepatectomia/métodos , Laparoscopia/métodos , Neoplasias Hepáticas/cirurgia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
13.
J Minim Invasive Gynecol ; 22(2): 255-60, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25460321

RESUMO

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.


Assuntos
Histerectomia/métodos , Laparoscopia , Miomectomia Uterina/instrumentação , Útero/patologia , Adulto , Feminino , Humanos , Histerectomia/instrumentação , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos , Países Baixos , Tamanho do Órgão , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Análise e Desempenho de Tarefas , Resultado do Tratamento
14.
J Minim Invasive Gynecol ; 22(5): 820-6, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25827327

RESUMO

STUDY OBJECTIVE: To estimate the cost-effectiveness of eliminating morcellation in the surgical treatment of leiomyomas from a societal perspective. DESIGN: Cost-effectiveness analysis. DESIGN CLASSIFICATION: Not applicable. SETTING: A theoretical cohort of women undergoing hysterectomy for myoma disease large enough to require morcellation. PATIENTS: None. INTERVENTIONS: None. MEASUREMENTS: A decision analysis model was constructed using probabilities, costs, and utility data from published sources. A cost-effectiveness analysis analyzing both quality-adjusted life years (QALYs) and cases of disseminated cancer was performed to determine the incremental cost-effectiveness ratio (ICER) of eliminating morcellation as a tool in the surgical treatment of leiomyomas. Costs and utilities were discounted using standard methodology. The base case included health care system costs and costs incurred by the patient for surgery-related disability. One-way sensitivity analyses were performed to assess the effect of various assumptions. MAIN RESULTS: The cost to prevent 1 case of disseminated cancer was $10 540 832. A strategy of nonmorcellation hysterectomy via laparotomy costed more ($30 359.92 vs $20 853.15) and yielded more QALYs (21.284 vs 21.280) relative to morcellation hysterectomy. The ICER for nonmorcellation hysterectomy compared with morcellation hysterectomy was $2 184 172 per QALY. Health care costs (prolonged hospitalizations) and costs to patients of prolonged time away from work were the primary drivers of cost differential between the 2 strategies. Even when the incidence of occult sarcoma in leiomyoma surgery was ranged to twice that reported in the literature (.98%), the ICER for nonmorcellation hysterectomy was $644 393.30. CONCLUSIONS: Eliminating morcellation hysterectomy as a treatment for myomas is not cost-effective under a wide variety of probability and cost assumptions. Performing laparotomy for all patients who might otherwise be candidates for morcellation hysterectomy is a costly policy from a societal perspective.


Assuntos
Histerectomia/economia , Laparoscopia/economia , Leiomioma/economia , Leiomioma/cirurgia , Neoplasias Uterinas/economia , Neoplasias Uterinas/cirurgia , Adulto , Idoso , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Feminino , Humanos , Histerectomia/instrumentação , Histerectomia/métodos , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Percepção Social
15.
J Minim Invasive Gynecol ; 22(1): 110-4, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25128851

RESUMO

STUDY OBJECTIVE: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. DESIGN: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). SETTING N/A PATIENTS: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. INTERVENTIONS: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. MEASUREMENTS AND MAIN RESULTS: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. CONCLUSIONS: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.


Assuntos
Histeroscopia/efeitos adversos , Intestinos/lesões , Leiomioma/cirurgia , Pólipos/cirurgia , Hemorragia Uterina/etiologia , Neoplasias Uterinas/cirurgia , Perfuração Uterina/etiologia , Bases de Dados Factuais , Eletrocoagulação , Feminino , Humanos , Histeroscopia/instrumentação , Estados Unidos , United States Food and Drug Administration , Miomectomia Uterina/efeitos adversos
16.
J Minim Invasive Gynecol ; 22(4): 564-72, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25623369

RESUMO

Minimally invasive gynecologic surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014, the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Despite the best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. This article is not meant to further deter gynecologists from using laparoscopic power morcellators, but rather to provide an interpretation of the FDA statement as to the patients for whom the use of power morcellation may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellation in the face of the recent FDA warning and litigation.


Assuntos
Histerectomia/efeitos adversos , Laparoscopia/efeitos adversos , Leiomioma/cirurgia , Miomectomia Uterina/efeitos adversos , Neoplasias Uterinas/prevenção & controle , Feminino , Humanos , Histerectomia/legislação & jurisprudência , Laparoscopia/legislação & jurisprudência , Inoculação de Neoplasia , Estados Unidos , United States Food and Drug Administration , Miomectomia Uterina/legislação & jurisprudência
17.
J Minim Invasive Gynecol ; 21(5): 928-34, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24780382

RESUMO

STUDY OBJECTIVE: To compare surgery-related outcomes of electric motorized morcellator (EMM) and transvaginal extraction (TVE) for myoma retrieval after laparoscopic myomectomy. DESIGN: A retrospective propensity-matched analysis of prospectively collected data (Canadian Task Force classification II-2). SETTING: A university teaching hospital. PATIENTS: One hundred women undergoing laparoscopic myomectomy. INTERVENTIONS: Laparoscopic myomectomy followed by myoma retrieval via TVE or EMM. MEASUREMENTS AND MAIN RESULTS: Fifty propensity-matched patient pairs (100 patients) undergoing laparoscopic myomectomy followed by myoma retrieval via TVE or EMM were studied. No significant differences were observed in baseline patient characteristics. Operative times were similar between groups (66 vs 73 minutes in the TVE and EMM group, respectively, p = .19). However, patients undergoing TVE experienced lower specimen retrieval time than patients undergoing extraction via EMM (5 [3-30] vs 7 [3-35] minutes, p < .001). Blood loss, transfusion, and complication rates were similar between groups. One retrieval-related complication occurred in the EMM group (bleeding from an incision using a morcellator requiring resuture). The need for an analgesic rescue dose was lower in the TVE group compared with patients in the EMM group (p = .03). Although overall satisfaction levels were similar between groups, TVE is related to higher cosmetic outcomes compared with EMM (9.5 [±0.6] vs 8.5 [±1], p < .001). CONCLUSION: TVE upholds the effectiveness of EMM, minimizing the operative time and potentially postoperative pain. Further large prospective studies are needed.


Assuntos
Laparoscopia , Leiomioma/cirurgia , Cirurgia Endoscópica por Orifício Natural , Hemorragia Pós-Operatória/prevenção & controle , Miomectomia Uterina/instrumentação , Neoplasias Uterinas/cirurgia , Adulto , Perda Sanguínea Cirúrgica , Estética , Feminino , Humanos , Tempo de Internação , Duração da Cirurgia , Satisfação do Paciente , Pontuação de Propensão , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
18.
J Minim Invasive Gynecol ; 21(3): 377-83, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24462590

RESUMO

STUDY OBJECTIVE: To assess all electromechanical morcellators used in gynecology to achieve an objective comparison between them and to make suggestions for improvements in future developments. DESIGN: Literature review. INTERVENTION: The PubMed, Web of Science, EMBASE, and MAUDE databases were systematically searched for all available literature using the terms "morcellator," "morcellators," "morcellate," "morcellation," and "morcellated." All articles with information on morcellation time and morcellated tissue mass or the calculated morcellation rate of electromechanical morcellators used for gynecologic laparoscopic surgery were included. For general data of an existing morcellator, the manufacturer was contacted and Google was searched. Data for morcellation rate, type of procedure, and general characteristics were compared. MEASUREMENTS AND MAIN RESULTS: Seven articles were suitable for analysis, and 11 different morcellators were found. In the past decades the morcellation rate has increased. The described morcellation rate ranged from 6.2 to 40.4 g/min. Motor peeling is currently the fastest working principle. Comparing hysterectomy and myomectomy per device, the Morcellex and Rotocut morcellators demonstrated a higher morcellation rate for myomectomy, 25.9 vs 30 g/min and 28.4 vs 33.1 g/min, respectively, although the X-Tract morcellator showed a higher rate for hysterectomy, 14.2 vs 11.7 g/min. CONCLUSION: Over the years, the morcellator has improved with respect to the morcellation rate. However, the morcellation process still has limitations, including tissue scattering, morcellator-related injuries, and the inevitable small blade diameter, which all come at the expense of the morcellation rate and time. Therefore, development of improved morcellators is required, with consideration of the observed limitations.


Assuntos
Histerectomia/instrumentação , Laparoscopia/instrumentação , Miomectomia Uterina/instrumentação , Feminino , Procedimentos Cirúrgicos em Ginecologia/instrumentação , Procedimentos Cirúrgicos em Ginecologia/métodos , Ginecologia/instrumentação , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Instrumentos Cirúrgicos
19.
J Minim Invasive Gynecol ; 21(6): 1118-20, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24865632

RESUMO

Uterine curettage may result in formation of intrauterine adhesions, which can predispose to recurrent miscarriage [1]. Herein is presented a video case report of a 24-year-old woman with recurrent miscarriages and recurrent intrauterine adhesions after treatment of non-progressive pregnancies. Targeted intrauterine pregnancy tissue removal using a hysteroscopic morcellator was performed to reduce the risk of adhesion recurrence. Successful removal of products of conception, without subsequent adhesion formation, and an ongoing viable pregnancy followed. Selective targeted removal of products of conception may offer some advantage to women with a predisposition to recurrent Asherman's syndrome.


Assuntos
Aborto Habitual/cirurgia , Ginatresia/cirurgia , Histeroscopia , Doenças Uterinas/cirurgia , Dilatação e Curetagem/instrumentação , Dilatação e Curetagem/métodos , Feminino , Ginatresia/complicações , Humanos , Histeroscopia/instrumentação , Histeroscopia/métodos , Gravidez , Recidiva , Aderências Teciduais/complicações , Aderências Teciduais/cirurgia , Doenças Uterinas/complicações , Adulto Jovem
20.
J Minim Invasive Gynecol ; 21(3): 486-91, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24333632

RESUMO

Morcellation at laparoscopy is a commonly used minimally invasive method to extract bulky tissue from the abdomen without extending abdominal incisions. Despite widespread use of morcellation, complications still remain underreported and poorly understood. We performed a systematic review of surgical centers in the United States to identify, collate and update the morcellator-related injuries and near misses associated with powered tissue removal. We searched articles on morcellator-related injuries published from 1993 through June 2013. In addition, all cases reported to MedSun and the FDA device database (MAUDE) were evaluated for inclusion. We used the search terms "morcellation," "morcellator," "parasitic," and "retained" and model name keywords "Morcellex," "MOREsolution," "PlasmaSORD," "Powerplus," "Rotocut," "SAWALHE," "Steiner," and "X-Tract." During the past 15 years, 55 complications were identified. Injuries involved the small and large bowels (n = 31), vascular system (n = 27), kidney (n = 3), ureter (n = 3), bladder (n = 1), and diaphragm (n = 1). Of these injuries, 11 involved more than 1 organ. Complications were identified intraoperatively in most patients (n = 37 [66%]); however, the remainder were not identified until up to 10 days postoperatively. Surgeon inexperience was a contributing factor in most cases in which a cause was ascribed. Six deaths were attributed to morcellator-related complications. Nearly all major complications were identified from the FDA device database and not from the published literature. The laparoscopic morcellator has substantially expanded our ability to complete procedures using minimally invasive techniques. Associated with this opportunity have been increasing reports of major and minor intraoperative complications. These complications are largely unreported, likely because of publication bias associated with catastrophic events. Surgeon experience likely confers some protection against these injuries. Understanding and implementing safe practices associated with the use of the laparoscopic morcellator will reduce these iatrogenic injuries.


Assuntos
Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Intestinos/lesões , Complicações Intraoperatórias/etiologia , Laparoscopia/efeitos adversos , Lesões do Sistema Vascular/etiologia , Cavidade Abdominal , Bases de Dados Factuais , Diafragma/lesões , Feminino , Procedimentos Cirúrgicos em Ginecologia/instrumentação , Humanos , Rim/lesões , Laparoscopia/instrumentação , Estados Unidos , Ureter/lesões , Bexiga Urinária/lesões
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