28 results on '"Malcolm G. Munro"'
Search Results
2. Office versus Institutional Operative Hysteroscopy: An Economic Model
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Malcolm G. Munro, Jamie L. Kasiewicz, and Vrunda B. Desai
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Operating Rooms ,Models, Economic ,Ambulatory Surgical Procedures ,Pregnancy ,Humans ,Obstetrics and Gynecology ,Female ,Hysteroscopy ,Anesthesia, Local - Abstract
Model and compare estimated health system costs and gynecologic practice revenues when hysteroscopic surgery is performed in the office or institutional setting, either an ambulatory surgical center (ASC) or a traditional operating room (OR).Economic modeling exercise.Nonclinical.An economic model was developed that included US reimbursement rates for the office and institutional settings and the inherent expenses required for office hysteroscopic surgery. For Current Procedural Terminology code 58558, hysteroscopic biopsy and/or polypectomy, total health system costs were estimated as follows: office, $1382.48; ASC, $1655.31; OR $2918.10. In the modeled office setting, costs for the same procedure were estimated from instrumentation and supply list prices obtained from vendors and staffing costs from national databases. Revenue and cost modeling were performed and compared both for 1 to 10 monthly procedure volumes and by hysteroscopic systems, whereas other elements of the procedure were standardized, including technique, staffing, generic supplies, and the use of local anesthesia. Four vendors provided system price information: 1 purpose built, 1 electromechanical, and 2 traditional. The projected office-based, per case net revenue with the purpose-built system was always greater than in the ASC or OR and relatively independent of monthly procedure volume (1 per month $743.59; 10 per month $876.17). For the traditional and electromechanical systems, it took from 2 to 5 monthly procedures to realize a net revenue greater than $239.39. Using 3 sets of vendor matched instruments, at 10 cases per month, the per case net revenue for the electromechanical system was $514.00, and for the 2 traditional systems $564.02 and $693.72.Performance of office-based hysteroscopic surgery is associated with reduced health system costs compared with the institutional environment. The net revenue for the practice was dependent on both the volume of procedures performed and the hysteroscopic system and technique selected.
- Published
- 2022
3. Excision of an Occult, Obstructed Hemivagina Under Laparoscopic Ultrasound Guidance in a Patient with Ohvira Syndrome
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Malcolm G. Munro, C Templeman, and H. Wirth
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Obstructed hemivagina ,medicine.medical_specialty ,business.industry ,Obstetrics and Gynecology ,Medicine ,Laparoscopic ultrasound ,Radiology ,business ,Occult - Published
- 2021
4. Iub™ Sead™ - A Novel Intra Uterine Ball: Spherical Endometrial Ablation Device
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Morris Wortman, Malcolm G. Munro, and Sergio Haimovich
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Uterus ,Obstetrics and Gynecology ,Surgery ,medicine.anatomical_structure ,Blood loss ,Cohort ,medicine ,Endometrial ablation ,Outpatient clinic ,Uterine cavity ,Intra uterine ,Adverse effect ,business - Abstract
Study Objective The aim of this study is to assess the safety and efficacy of the IUB SEAD™ (Intra Uterine Ball: Spherical Endometrial Ablation Device) introducing silver nitrate to the uterus in women suffering from abnormal uterine bleeding. We present results of 6 months follow up period post treatment. Design Open-label multicenter study to assess the safety and efficacy of the IUB SEAD™ device in premenopausal women with predictable menstrual cycles, who suffer from AUB. Women with HMB were enrolled who had an average pictorial blood loss assessment chart (PBAC) score ≥ 150 over for 3 months. Setting The study was performed in the outpatient clinics of 2 Bulgarian medical centres between September 2019 and December 2020. Patients or Participants 16 women with HMB (PBAC>150) at least 3 months before inclusion were enrolled. Interventions Eligible subjects who met all the inclusion/exclusion criteria were treated during the first 7 days following the cessation of menses. The SEAD™ device was inserted into the uterine cavity via vaginal approach. The device was left in the uterus for 30 (±5) minutes and then removed. Measurements and Main Results A total of 16 participants aged 37-50 (mean = 43) were enrolled with a mean baseline PBAC score of 424; 14 of 16 completed follow up requirements and were evaluable at 6 months. All procedures were completed successfully without device/procedure-related adverse events. At 6 months post-treatment the mean PBAC score was 95 with 55% of the overall cohort ≤75 and 72% ≤ 100 and a mean percentage of 83% reduction. The mean procedure related pain score was ≤2 (mild).* Conclusion The IUB SEAD™ device is safe and effective in treating HMB in an outpatient environment. Future studies with larger number of patients are planned. *Results may vary until presentation date.
- Published
- 2021
5. Elagolix with Add-Back Therapy in Women with Heavy Menstrual Bleeding, Uterine Fibroids, and Anemia: Subgroup Analysis of Two Phase 3 Trials
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Malcolm G. Munro, Ayman Al-Hendy, S. Eichner, Linda D. Bradley, M. Kumar, Z. Xue, J.H. Kim, and Veronica Gillispie
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Weakness ,medicine.medical_specialty ,Uterine fibroids ,business.industry ,Anemia ,Obstetrics and Gynecology ,Subgroup analysis ,medicine.disease ,Placebo ,Gastroenterology ,Quality of life ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Clinical endpoint ,Hemoglobin ,medicine.symptom ,business - Abstract
Study Objective Heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) often leads to anemia, which may cause fatigue and weakness in affected women. This analysis evaluated clinical improvements in menstrual blood loss (MBL), anemia, and quality of life (QoL) in elagolix-treated women who had HMB, UF, and severe or mild anemia at the time of Elaris UF-1 or UF-2 study entry. Design Pooled subgroup analysis of UF-1 and UF-2, two replicate double-blind, randomized, placebo-controlled, 6-month phase 3 studies. Setting Outpatient. Patients or Participants Subgroup of premenopausal women with HMB (>80mL alkaline hematin-measured MBL/cycle), ultrasound-confirmed UF, and severe (hemoglobin [Hgb] Interventions Elagolix 300mg BID with add-back therapy (estradiol 1mg/norethindrone acetate 0.5mg QD) (elagolix+E2/NETA), compared with placebo. Measurements and Main Results In UF-1 and UF-2, a total of 426/591 (72%) women who received elagolix+E2/NETA or placebo had severe (n=189) or mild anemia (n=237) at study entry. Women with severe anemia had a numerically greater mean baseline MBL (301.6±204.1mL) than women with mild anemia (225.8±128.2mL). Of the elagolix+E2/NETA-treated women with severe anemia at study entry, 74.1% met the study's primary endpoint (had both 2g/dL from baseline to month 6, and 51.1% achieved Hgb≥12g/dL at month 6 (P Conclusion Women with HMB, UF, and severe or mild anemia at study entry demonstrated clinical improvements in MBL, anemia, and QoL with elagolix+E2/NETA treatment.
- Published
- 2020
6. Classification and Reporting Systems for Adenomyosis
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Malcolm G. Munro
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Diagnostic Imaging ,medicine.medical_specialty ,Psychological intervention ,Clinical correlation ,03 medical and health sciences ,0302 clinical medicine ,Clinical decision making ,Image Interpretation, Computer-Assisted ,Medicine ,Humans ,Medical physics ,Adenomyosis ,Ultrasonography ,030219 obstetrics & reproductive medicine ,business.industry ,Microsoft excel ,Obstetrics and Gynecology ,Subject (documents) ,medicine.disease ,Magnetic Resonance Imaging ,Transvaginal ultrasound ,Research Design ,030220 oncology & carcinogenesis ,Data Interpretation, Statistical ,Female ,business - Abstract
Objective To conduct a review of the available histologic and image-based classification systems to determine which of these systems, if any, provide clinical utility for prognosis or the selection of appropriate therapeutic interventions. Data Sources PubMed in addition to the bibliographies of identified publications. Methods of Study Selection One investigator searched PubMed using Medical Subject Headings terms that included “Adenomyosis,” “Classification,” “Ultrasound Classification,” “MRI Classification,” and “Diagnosis,” Tabulation, Integration and Results Search results were tabulated in a Microsoft Excel workbook that facilitated the identification of duplicate entries. Publications were allocated into separate categories that included histopathologic, ultrasound, and MRI classifications. Identified systems associated with clinical outcomes were separately tabulated. Abstracts of 1669 articles were reviewed and 278 were identified for review of full text. Twenty-five were considered potentially relevant from the PubMed review and an additional 17 were found in bibliographies. In the 42 full-text articles that were reviewed in detail, 9 histologic classifications were identified, 4 of which were accompanied by an attempt at clinical correlation, 1 of which described a correlation with the outcome of medical, procedural, or surgical intervention. There were 9 image-based reporting or classification systems, 2 using transvaginal ultrasound and 7 using MRI, 3 of which included correlations with intervention outcomes, although these were surrogate (imaging) and not clinical outcomes. Conclusion There is inconsistency in histopathologic definitions, and there is no uniformly accepted or validated system of image-based reporting or classification that can inform clinical decision making. There exists a need for harmonized classification systems for both ultrasound and MRI that agree with the histopathologic features of the disorder.
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- 2019
7. Essentials in Minimally Invasive Gynecology Manual Skills Pilot Validation Trial
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Nadia Gomez, Kim Thayn, Erica Stockwell, David L. Howard, Arnold P. Advincula, Amy N. Brown, Malcolm G. Munro, Saba Saadat, W. Volker, and Bruce S. Kahn
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Laparoscopic surgery ,Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Psychological intervention ,Pilot Projects ,Certification ,Hysteroscopy ,Likert scale ,Gynecologic Surgical Procedures ,Specialty Boards ,Medicine ,Humans ,Minimally Invasive Surgical Procedures ,Prospective Studies ,Fellowships and Scholarships ,Simulation Training ,Face validity ,Gynecology ,Surgeons ,business.industry ,Obstetrics and Gynecology ,Construct validity ,Internship and Residency ,Reproducibility of Results ,Hand ,United States ,Sample size determination ,Female ,Laparoscopy ,Clinical Competence ,Surgical simulation ,business - Abstract
Study Objective To evaluate the Essentials in Minimally Invasive Gynecology (EMIG)- Fundamentals of Laparoscopic Surgery Laparoscopic Simulation System and the EMIG Hysteroscopy Simulation System for face validity and functionality in a pilot testing environment. Design A prospective controlled pilot study. Setting Three teaching institutions in the US Southwest. Subjects Twenty-seven residents and gynecologists, with 22 fitting who fit 1 of 4 categories of exposure to hysteroscopic and laparoscopic surgery and surgical simulation. Eleven were postgraduate year 1 and 5 postgraduate year 3, 1 was American Board of Obstetrics & Gynecology certified, and 5 were either fellows in-training or had completed a fellowship in minimally invasive gynecologic surgery. Interventions After completing a screening survey, each subject was exposed to a structured orientation to the 2 simulation systems and then tested with proctor supervision on the 5 laparoscopic and 2 hysteroscopic exercises. A short 5-point Likert questionnaire designed to determine face validation and question clarity was administered to each subject at sites 2 and 3. Measurements and Main Results Face validity was high for each of the 7 exercises (means ranged from 4.8 to 4.9 of 5), and subjects considered instructions to be clear (means from 4.7 to 4.9). The recorded exercise times generally reduced with increasing levels of training, although the sample sizes were not designed to determine significance given the pilot design. Similarly, exercise errors were generally less frequent with increasing experience. The systems, including the devices and recording mechanisms, performed well, and proctor evaluation and training were satisfactory. Conclusion The EMIG laparoscopic and hysteroscopic simulations systems were considered to have good face validity and appear to be suitable for a construct validation trial to confirm their utility in distinguishing among trainees and practitioners with a wide spectrum of endoscopic surgical experience. The recording and specimen storage mechanisms will allow for multiple proctors to rate a candidate's performance, thereby enhancing evaluation consistency and quality.
- Published
- 2019
8. Assessment of Gynecologic Laparoscopy Simulation Curriculum for Development of Fundamentals of Laparoscopy Surgery Psychomotor Skills
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V.H. Yu and Malcolm G. Munro
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Psychomotor learning ,medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Psychological intervention ,Obstetrics and Gynecology ,Endoscopy ,Surgery ,Obstetrics and gynaecology ,Gynecologic laparoscopy ,medicine ,Laparoscopy ,business ,Curriculum ,Cohort study - Abstract
Study Objective To investigate the utility of a gynecologic laparoscopy simulation curriculum designed for mid-level obstetrics and gynecology (OBGYN) residents in the five Fundamentals of Laparoscopy Surgery (FLS) skills. The hypothesis was that residents would demonstrate significant improvement in all tasks. Design A cohort study. Setting A community based OBGYN residency education program. Patients or Participants A total of 51 2nd and 3rd year residents. Interventions A comprehensive, 10 – week-long gynecologic endoscopy program, comprising both cognitive and manual skills. After an orientation week, formal assessment of baseline time and accuracy for each of the 5 FLS exercises was obtained on each resident by an FLS-certified faculty. Each week thereafter comprised a 3-hour training session with the same faculty that included approximately 90 minutes of hands-on psychomotor training using the FLS Laparoscopic System. All residents had 24 hour a day access to a training facility. On week 9, formal testing was repeated by the same faculty and the data entered into an Excel database. Measurements and Main Results There were 51 residents in the 10-year period and between 38 and 46 pairs of data for the 5 skills were evaluable. The baseline and week 9 completion times in seconds (SD) were as follows: Peg transfer 90.8 (40.1) and 59.4 (20.5); Pattern cut 190.7 (87.9) and 113.8 (51.0); Ligating loop 92.1 (39.6) and 65.1 (31.2); Extracorporeal tie 230.9 (88.3) and 137.8 (42.2); Intracorporeal tie 249.3 (97.9) and 134.1 (69.5). All differences were significant P Conclusion Mid-level OBGYN residents exposed to this gynecologic laparoscopy simulation training program significantly improved performance in the five FLS skills. Consequently, it may serve as a model for residency training programs. However, the absence of a cognitive and psychomotor hysteroscopic component in FLS is noteworthy and a shortcoming for OBGYN training programs.
- Published
- 2020
9. The Surgical 'Robot' in Benign Gynecology: Surgical Advance or a Set of Costly Training Wheels?
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Malcolm G. Munro
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medicine.medical_specialty ,medicine.medical_treatment ,MEDLINE ,Hysterectomy ,Article ,Uterine Cervical Diseases ,03 medical and health sciences ,0302 clinical medicine ,Robotic Surgical Procedures ,medicine ,Humans ,030212 general & internal medicine ,Set (psychology) ,Laparoscopy ,Gynecology ,030219 obstetrics & reproductive medicine ,medicine.diagnostic_test ,business.industry ,General surgery ,Obstetrics and Gynecology ,Surgery ,Female ,business ,Surgical robot - Abstract
We conducted a systematic review and meta-analysis to assess the safety and effectiveness of robotic versus laparoscopic hysterectomy in women with benign uterine disease, as determined by randomized studies. We searched MEDLINE, EMBASE, the Cochrane Library, ClinicalTrials.gov, and Controlled-Trials.com from inception to October 9th, 2014, using the intersection of the themes “robotic” and “hysterectomy.” We included only randomized and quasi-randomized controlled trials of robotic versus laparoscopic hysterectomy in women for benign disease. Four trials met inclusion criteria and were included in the analyses. Data was extracted and studies were assessed for methodological quality in duplicate. For meta-analysis, we used random effects to calculate pooled risk ratios (RR) and weighted mean differences. For our primary outcome, we used a modified version of the Expanded Accordion Severity Grading System to classify perioperative complications. We identified 41 total complications among 326 patients. When comparing robotic to laparoscopic hysterectomy, we found no statistically significant differences in the rate of class 1 and 2 complications (RR=0.66, 95% Confidence Interval (CI) 0.23–1.89) or in the rate of class 3 and 4 complications (RR=0.99, 95%CI 0.22–4.40). Analyses of secondary outcomes were limited due to heterogeneity, but showed no significant benefit of robotic compared to laparoscopic technique in terms of length of hospital stay (weighted mean difference= −0.39 days, 95%CI −0.92–0.14), total operating time (weighted mean difference=9.0 minutes, 95%CI −31.27–47.26), conversions to laparotomy, or blood loss. Outcomes of cost, pain, and quality of life were inconsistently reported and not amenable to pooling. Current evidence demonstrates neither statistically significant, nor clinically meaningful differences in surgical outcomes between robotic and laparoscopic hysterectomy for benign disease. The role of robotic surgery in benign gynecology remains unclear.
- Published
- 2016
10. EMIG Simulation Systems Construct Validation Trial: Hysteroscopic Component
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Arnold P. Advincula, Kim Thayn, and Malcolm G. Munro
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Laparoscopic surgery ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Obstetrics and Gynecology ,Construct validity ,Simulation system ,Obstetrics and gynaecology ,Data quality ,Cohort ,Physical therapy ,medicine ,Surgical simulation ,business ,Fellowship training - Abstract
Study Objective Construct validation of the EMIG Laparoscopic Surgery Simulation System. Design A prospective, controlled cohort comparison. Setting Thirteen teaching institutions in the US and Canada and an AAGL Congress Patients or Participants 221 subjects who fit one of 4 categories of exposure to laparoscopic surgery and surgical simulation: 77 novices within 100 days of starting posgraduate year 1 (PGY-1); 71 within the first 100 days of starting PGY-3; 30 American Board of Obstetrics and Gynecology (ABOG) certified and no additional fellowship training (“Proficient”); 43 who had completed the two-year Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS). Interventions Subjects were oriented to the simulation system and then tested under proctor supervision on the 5 EMIG laparoscopic exercises. These included the sleeve to peg transfer (L-1); the circular pattern cut (L-2); extracorporeal knotting (L-3); intracorporeal knotting (L-4); and a running suture (L-5). Time and accuracy scoring were entered electronically on site, but sessions were video recorded and study materials such as cutting and suturing targets were labeled and stored for subsequent review to optimize data quality. Measurements and Main Results Each exercise was timed, and a number of objective metrics recorded that reflected cutting and suturing accuracy and technique. Each exercise had a “time cap”; if a subject had not completed the exercise by the end of the allotted time, they were categorized “Did Not Complete” and the maximum time was entered for data analysis. Preliminary data analysis demonstrates that the novice group consistently demonstrated the poorest performance and the FMIGS cohort consistently the best. The PGY-3 and “Proficient” cohorts were generally similar to each other but each performed better than the PGY-1 group and well below the FMIGS group. Conclusion The EMIG Laparoscopic Simulation System can be used to distinguish amongst PGY-1, PGY-3, Proficient and FMIGS subjects. FMIGS-trained subjects consistently had the best results with almost no “Did not Complete” outcomes.
- Published
- 2019
11. 2663 Essentials in Minimally Invasive Gynecology (Emig) Manual Skills Pilot Validation Trial
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Erica Stockwell, Kim Thayn, Bruce S. Kahn, Malcolm G. Munro, W. Volker, S Saadat, NA Gomez, David L. Howard, and Amy N. Brown
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Laparoscopic surgery ,medicine.medical_specialty ,030219 obstetrics & reproductive medicine ,business.industry ,medicine.medical_treatment ,Psychological intervention ,Obstetrics and Gynecology ,Construct validity ,Simulation system ,Likert scale ,03 medical and health sciences ,0302 clinical medicine ,Sample size determination ,030220 oncology & carcinogenesis ,medicine ,Medical physics ,business ,Face validity ,Cohort study - Abstract
Study Objective Evaluate the EMIG-FLS Laparoscopic Simulation System and the EMIG Hysteroscopy Simulation System for face validity and functionality in a pilot testing environment. Design A pilot cohort study Setting Three teaching institutions in the US Southwest Patients or Participants Twenty-seven residents and gynecologists who fit one of three categories of exposure to hysteroscopic and laparoscopic surgery and surgical simulation. Twelve were postgraduate year 1 (PGY-1); five were PGY-3, 1 was ABOG certified, and 5 were either fellows in-training or had completed a Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS). Interventions After completing a screening survey, each subject was exposed to a structured orientation to the two simulation systems and then tested with proctor supervision on the 5 laparoscopic and 2 hysteroscopic exercises. A short 5-point Likert questionnaire designed to determine face validation and question clarity was administered to each subject at sites 2 and 3. Measurements and Main Results Face validity was high for each of the 7 exercises (means ranged from 4.8 to 4.9 out of 5) and subjects considered instructions to be clear (means ranged from 4.7 to 4.9). The recorded exercise times generally reduced with increasing levels of training although the sample sizes were not designed to determine significance given the pilot design. Similarly, exercise errors were generally less frequent with increasing experience. The systems, including the devices and recording mechanisms performed well and proctor evaluation and training were satisfactory. Conclusion The EMIG laparoscopic and hysteroscopic simulations systems were considered to have good face validity and appear to be suitable for a construct validation trial to confirm their utility in distinguishing amongst trainees and practitioners with a wide spectrum of endoscopic surgical experience. The recording and specimen storage mechanisms will allow for multiple proctors to rate a candidate's performance, thereby enhancing evaluation consistency and quality.
- Published
- 2019
12. Uterine Sounding: Is There a Difference between Blind and Hysteroscopically Directed Measurements?
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Jacqueline M. Guerrero and Malcolm G. Munro
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Adult ,Uterine Diseases ,030219 obstetrics & reproductive medicine ,Biometry ,Uterus ,Obstetrics and Gynecology ,Hysteroscopy ,Middle Aged ,03 medical and health sciences ,0302 clinical medicine ,Cross-Sectional Studies ,Pregnancy ,030220 oncology & carcinogenesis ,Humans ,Female ,Aged - Abstract
To evaluate the accuracy of traditional blind uterine sounding in measuring uterine cavity length (UCL), compared with measurement by hysteroscopic guidance.A cross-sectional descriptive study (Canadian Task Force classification III).Academic multispecialty medical center.Fifty-eight women undergoing elective hysteroscopic procedures.UCL measurement.UCL measurements were obtained by the traditional blind sounding technique and by hysteroscopically directed measurement. Hysteroscopic measurements were assumed to represent true uterine cavity length. Differences between the 2 measurements were calculated to analyze error and bias.Mean UCL for blind sounding and hysteroscopically directed measurements were 80.81 mm and 86.55 mm, respectively. The magnitude of error between measurements was10 mm in 36.2% of cases, with underestimation of true UCL in 55.17% of cases.True UCL is underestimated by blind sounding, and the frequency, magnitude, and direction of error may be greater than are clinically acceptable.
- Published
- 2017
13. Economics and Energy Sources
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Malcolm G. Munro
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Laparoscopic surgery ,Service (systems architecture) ,Surgical instrumentation ,Minimal access surgery ,business.industry ,medicine.medical_treatment ,Electrosurgery ,Obstetrics and Gynecology ,Risk analysis (engineering) ,Costs and Cost Analysis ,medicine ,Operating time ,Humans ,Laparoscopy ,Instrumentation (computer programming) ,Energy source ,business ,Simulation ,Minimally invasive procedures - Abstract
Energy-based instrumentation has not only facilitated the rapid adoption of laparoscopic surgery, but could be considered essential for the completion of abdominal and pelvic procedures under endoscopic guidance. For decades, relatively simple and generic reusable monopolar and bipolar systems were the only options available. More recently, the available options for energy-based surgical instrumentation have become more crowded with the introduction of ultrasound-based cutting and sealing instruments and proprietary, impedance monitoring radiofrequency coagulation devices. Such instrumentation is presented as being easier to use as well as providing greater safety and efficacy. However, these new instruments typically require the expenditure of capital for proprietary energy generators and are usually designed to be for single use, a circumstance that increases per case costs, a circumstance that begs the question of value. Do the additional costs expended for the more expensive devices translate into reduced complications, faster operating time, or even wider access to minimally invasive procedures because they enable more surgeons to offer the service? Herein is explored the complex economic issues associated with the use of energy-based surgical devices as they apply to minimal access surgery in general and to laparoscopic procedures specifically.
- Published
- 2013
14. AAGL Practice Report: Practice Guidelines for the Management of Hysteroscopic Distending Media
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Karl Storz, Malcolm G. Munro, Franklin D. Loffer, Jason Abbott, Volker R. Jacobs, Ludovico Muzii, Aagl Advancing Minimally Invasive Gynecology Worldwide, Paul D. Indman, Ceana H. Nezhat, Tommaso Falcone, Olav Istre, and Togas Tulandi
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medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Hysteroscopy ,Obstetrics and Gynecology ,Medicine ,Operative hysteroscopy ,Guideline ,business ,Intensive care medicine ,Surgery - Abstract
The objective of this guideline is to provide clinicians with evidence-based information about commonly used and available hysteroscopic distending media to guide them in their performance of both diagnostic and operative hysteroscopy. While necessary for the performance of hysteroscopy and hysteroscopically-directed procedures, distending media, if absorbed systemically in sufficient amounts, can have associated adverse events, including life-threatening complications. Consequently, understanding the physical properties and the potential risks associated with the use of the various distending media is critical for the safe performance of hysteroscopic procedures. This report was developed under the direction of the Practice Committee of the AAGL as a service to their members and other practicing clinicians.
- Published
- 2013
15. Surgical Simulation: Where Have We Come From? Where Are We Now? Where Are We Going?
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Malcolm G. Munro
- Subjects
SIMPLE (military communications protocol) ,Multimedia ,business.industry ,Process (engineering) ,Software development ,Obstetrics and Gynecology ,Context (language use) ,Virtual reality ,computer.software_genre ,Dilemma ,User-Computer Interface ,Gynecologic Surgical Procedures ,Health care ,Humans ,Systems design ,Medicine ,Computer Simulation ,Laparoscopy ,Clinical Competence ,business ,computer - Abstract
It is now clear to most stakeholders that acquisition of surgical psychomotor skills is best achieved outside of the clinical operating room, in the context of a simulated environment. Endoscopic simulation can be accomplished using simple "box" simulators or video trainers, and virtual reality simulation is now possible using microprocessor-controlled systems. Structured surgical training performed outside of the operating room environment is relatively new to health care, a circumstance different from the process of pilot training, in which simulation has been a mainstay for more than 75 years and in which virtual reality simulation is now the norm. Those charged with surgical education are faced with a dilemma as, while attempting to understand the basic goals of simulation, they are simultaneously faced with choice between relatively inexpensive video trainers and the often prohibitively expensive virtual reality systems. This article explores the history of simulation, reports the results of a modified systematic review of currently available systems and performance, and identifies the gaps in current research and development. It is apparent that available video trainers provide the opportunity for skill development that at present is not surpassed by virtual reality systems. In the future, there will likely be an increasing role for virtual reality; however, challenges remain that include determination of the appropriate metrics and system design, and the fiscal resources necessary for the required hardware and related software development.
- Published
- 2012
16. Use of Local Anesthesia for Office Diagnostic and Operative Hysteroscopy
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Philip G. Brooks and Malcolm G. Munro
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Research design ,Analgesics ,medicine.diagnostic_test ,Office Visits ,business.industry ,Administration, Topical ,MEDLINE ,Obstetrics and Gynecology ,Hysteroscopy ,law.invention ,Administration, Intravesical ,Patient satisfaction ,Systematic review ,Randomized controlled trial ,law ,Anesthesia ,Anesthetic ,medicine ,Humans ,Local anesthesia ,business ,Anesthesia, Local ,medicine.drug - Abstract
Background There is a variety of potential advantages to performing hysteroscopically-directed procedures on an awake patient in an office procedure room setting that include increased safety, reduced utilization of resources, and improved patient satisfaction. However, the ideal approach to local uterine anesthesia has/have yet to be determined. Objective Identification, categorization, and evaluation of published randomized clinical trials (RCTs) comparing local anesthesia to placebo or no treatment for the performance of hysteroscopy. Methods The Cochrane database of systematic reviews, MEDLINE, and ACP Journal Club were queried for related RCTs. In addition, we located a number of additional studies by identifying and reviewing references in selected papers. These were then reviewed for appropriateness and categorized by allocating them to one of the following types of local anesthesia: Intracervical, paracervical, topical intracavitary, topical cervical, and combined approaches. Each were evaluated for patient factors as well as anesthetic location, anesthetic agent, time from application to procedure, instrument features, and the procedures performed. Results A total of 36 studies were identified of which 19 met the criteria for our review; 6 paracervical, 4 intracervical, 7 topical intracavitary, 2 topical cervical; there was also one systematic review of RCTs. Overall, there was substantial heterogeneity in technique in all groups and only with paracervical anesthesia was there a consistent anesthetic effect demonstrated. Many studies were performed with application to procedure times that were less than the time required for maximal anesthetic effect. There were no studies identified where more than one technique was used. Conclusions It appears that paracervical anesthesia is useful but the value of other techniques is difficult to evaluate because of limitations of technique and research design. Future investigation should be designed to evaluate longer application to procedure times, a variety of anesthetic agents, concentrations and volumes, and, given the complex innervation of the uterus, strategies that target more than one site. Pain outcomes should be stratified to identify the impact on various components of the procedure. Published studies have largely been limited to diagnostic hysteroscopy so there is also a need to evaluate a greater variety of hysteroscopic procedures.
- Published
- 2010
17. Endometrial hydrothermablation: A comparison of short-term clinical effectiveness in patients with normal endometrial cavities and those with intracavitary pathology
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Stacey P. Rosenbaum, Malcolm G. Munro, and Marc Fried
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Adult ,Pathology ,medicine.medical_specialty ,Time Factors ,Clinical effectiveness ,Hysteroscopy ,Risk Assessment ,Severity of Illness Index ,Patient satisfaction ,Reference Values ,Electrocoagulation ,Humans ,Medicine ,In patient ,Retrospective Studies ,Health related quality of life ,Gynecology ,Equipment Safety ,Leiomyoma ,Task force ,business.industry ,Obstetrics and Gynecology ,Uterine bleeding ,Equipment Design ,Middle Aged ,Treatment Outcome ,Case-Control Studies ,Endometrial Hyperplasia ,Uterine Neoplasms ,Cohort ,Female ,Uterine Hemorrhage ,business ,Follow-Up Studies ,Cohort study - Abstract
Study objective To evaluate preprocedure and postprocedure health related quality of life scores and patient satisfaction of women treated with hydrothermablation for abnormal uterine bleeding (AUB) with and without endometrial intracavitary pathology. Design Cohort study (Canadian Task Force classification II-2). Setting Two institutions from a large managed care organization. Patients Forty-seven English-speaking premenopausal women with AUB, both with and without leiomyomas or polyps in the endometrial cavity treated from January 2001 through March 2003. Intervention Patients had been treated with endometrial hydrothermablation. Measurements and main results A standardized system, validated in English (the Ruta score), was used for evaluating health-related quality-of-life impact of uterine bleeding. Following the index procedure, patients were asked to assess both baseline and current status. A simple five-point satisfaction scale also was administered. Outcomes from subjects with and without documented endometrial structural pathology were compared. Follow-up ranged from 5 to 25 months with a mean of 12.7 (SD 5.2). Twenty women in the cohort had normal endometrial cavities, and 27 demonstrated intracavitary pathology, most often leiomyomas. For both groups, baseline and follow-up scores were similar. Satisfaction scores also were similar with 80.0% of the subjects with normal endometrial cavities and 72.7% of those with abnormal cavities satisfied or highly satisfied with the outcome. Conclusion Endometrial hydrothermablation seemed to be effective for AUB-affected women, both with and without pathologic lesions in the endometrial cavity.
- Published
- 2005
18. Reply
- Author
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Malcolm G. Munro
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Psychotherapist ,business.industry ,Obstetrics and Gynecology ,Medicine ,business - Published
- 2015
19. Radiofrequency Electrical Energy Guidelines for Authors: What’s in a Name?
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Malcolm G. Munro, George A. Vilos, Andrew I. Brill, and Jason Abbott
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Publishing ,Technology Transfer ,Information Dissemination ,business.industry ,Electric potential energy ,Electrical engineering ,Humans ,Obstetrics and Gynecology ,Medicine ,business ,Pulsed Radiofrequency Treatment - Published
- 2015
20. Hysteroscopic sterilization: 10-year retrospective analysis of worldwide pregnancy reports
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Barbara S. Levy, John E. Nichols, S. Veersema, Malcolm G. Munro, and M.P.H. Vleugels
- Subjects
Adult ,medicine.medical_specialty ,Databases, Factual ,Pregnancy Rate ,Sterilization, Tubal ,Hysteroscopy ,Global Health ,Pregnancy ,Interim ,Outcome Assessment, Health Care ,medicine ,Humans ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,Obstetrics ,Sterilization, Reproductive ,Obstetrics and Gynecology ,Retrospective cohort study ,medicine.disease ,Pregnancy rate ,Essure ,Family planning ,Patient Compliance ,Women's Health ,Female ,business ,Medical literature - Abstract
Study Objective To identify factors that might contribute to pregnancies reported after hysteroscopic sterilization worldwide. Design Retrospective review of commercial data compiled from the MAUDE database, medical literature, and manufacturer reports received during commercial distribution of hysteroscopic sterilization micro-inserts from 2001 through 2010 (Canadian Taskforce classification III descriptive study). Measurements and Main Results From 2001 through 2010, 497 305 hysteroscopic sterilization kits were distributed worldwide, and 748 pregnancies were reported, i.e., 0.15% of the estimated user population based on the number of distributed kits. The data were sufficient to enable analysis of 508 pregnancies for potential contributing factors and showed most to be associated with patient or physician noncompliance (n = 264) or misinterpreted confirmation tests (n = 212). Conceptions deemed to have occurred within 2 weeks of the procedure and therefore too early for detection were identified in 32 cases. Conclusion Although there are limitations to the dataset and the study design is retrospective, it represents the largest body of cumulative hysteroscopic sterilization data available to date. Of the 748 pregnancies reported, it is apparent that some might have been prevented with greater patient and clinician attention to interim contraceptive use and counseling and with more rigorous evaluation and informed interpretation of the procedure confirmation tests. Although the estimated pregnancy rate based on such a dataset is likely an underestimation, it does suggest that the evaluable field performance of hysteroscopic sterilization micro-inserts is consistent with the labeled age-adjusted effectiveness of 99.74% at 5 years.
- Published
- 2013
21. A guide to manuscript review for the Journal of Minimally Invasive Gynecology
- Author
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Barbara S. Levy, Krisztina Bajzak, and Malcolm G. Munro
- Subjects
medicine.medical_specialty ,business.industry ,Gynecology ,Obstetrics and Gynecology ,Medicine ,Humans ,Medical physics ,Periodicals as Topic ,business - Published
- 2008
22. Uterine artery embolization versus occlusion for uterine leiomyomas: a pilot randomized clinical trial
- Author
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Michael Ngo, Keith Terasaki, Eve Cunningham, Lorena Barreda, and Malcolm G. Munro
- Subjects
Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Pain ,Pilot Projects ,Radiography, Interventional ,law.invention ,Catheterization ,Hospitals, University ,Postoperative Complications ,Uterine artery embolization ,Randomized controlled trial ,law ,medicine.artery ,Leiomyomatosis ,Occlusion ,medicine ,Humans ,Uterine artery ,Intraoperative Complications ,Menorrhagia ,Uterine leiomyoma ,business.industry ,Uterus ,Obstetrics and Gynecology ,Pain scale ,Perioperative ,Middle Aged ,Embolization, Therapeutic ,Community hospital ,Surgery ,Uterine Neoplasms ,Female ,business - Abstract
To compare perioperative pain and institutional use for women undergoing transcatheter uterine artery embolization (UAE) and transcatheter uterine artery occlusion (UAO) for the treatment of heavy uterine bleeding associated with uterine leiomyomas.A pilot double-blind, randomized clinical trial (Canadian Task Force classification I).Large, university-affiliated community hospital with multiple residency programs including obstetrics and gynecolgoy and radiology.Premenopausal women with heavy uterine bleeding related to uterine leiomyomas were enrolled.Either a standard UAE with microspheres or UAO using vascular coils was used. The main outcome measures were analgesic use, institutional stay, and postprocedural numeric pain scales.Sixteen women were enrolled and 14 underwent study procedures (UAE n = 8, UAO n = 6). Baseline Aberdeen Menorrhagia Severity Scale scores, also known as the Ruta scores, were similar in each group (UAE = 54, UAO = 53). Median preprocedural uterine volume was similar for each group (UAE = 557 mL, UAO = 612 mL). The median postprocedural pain scale was less for UAO than UAE (UAO 1, UAE 5; p.05). Six patients with UAE and no patients with UAO required parenteral narcotic analgesia in the recovery room (p.05) (median UAO 0 and UAE 1). Patients with UAE used 6 hospital nights and patients with UAO used 1 hospital night (p =.09) (median UAO 0 and UAE 1). Three-month Aberdeen Menorrhagia Severity Scale scores were reduced to a similar degree in each group (UAE = 58%, UAO = 63%).Transcatheter UAO is a promising alternative transcatheter technique for the treatment of symptoms related to uterine leiomyomas, with less postprocedural pain, reduced requirements for analgesics, and shorter hospital stays than transcatheter UAE. Although the results of the study are promising, larger-scale trials with longer follow-up are needed to both confirm these results and evaluate the long-term efficacy of transcatheter UAO.
- Published
- 2007
23. Mechanisms of thermal injury to the lower genital tract with radiofrequency resectoscopic surgery
- Author
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Malcolm G. Munro
- Subjects
Models, Anatomic ,medicine.medical_specialty ,Uterus ,Hysteroscopy ,Electric Capacitance ,Introitus ,medicine ,Hysteroscopes ,Animals ,Humans ,Intraoperative Complications ,Cervical canal ,Cervix ,medicine.diagnostic_test ,Thermal injury ,business.industry ,Burns, Electric ,Obstetrics and Gynecology ,Genitalia, Female ,Surgery ,Perineum ,medicine.anatomical_structure ,Vagina ,Catheter Ablation ,Female ,business - Abstract
Study objective Identification of mechanisms of thermal injury to the lower genital tract during radiofrequency (RF) resectoscopic surgery. Design Laboratory comparative study using uterovaginal tissue models. Setting University surgical laboratory. Patients No patients involved. Interventions A tissue model was created to simulate the uterus, contiguous posterior vaginal wall, and the introitus. Instrumentation included a RF electrosurgical generator; a continuous-flow resectoscope; and rollerball electrodes, both intact and with insulation defects created in a standardized fashion. The resectoscope was serially activated, varying electrode insulation defects and RF waveforms and wattage, both in open-circuit conditions, with or without cervical contact, and with variable amounts of the external sheath within the simulated cervical canal. The cervix was either overdilated or minimally dilated so that the surrogate cervical tissue was snug to the external sheath. After activation of the generator, the external sheath was brought into contact with the proximal vagina and perineum, any visible arcing was noted, and tissue effects were visually graded according to a zero-to-three scale. Measurements and main results When the resectoscope was in contact with the cervix, the prerequisites for vaginal injury included cervical overdilation, a proximal electrode insulation defect, and less than 2 cm of the external sheath in the canal. There was greater risk with larger electrode insulation defects located beside the telescope, and there was a greater degree of coupling and injury with high voltage outputs. Conclusion The incidence of vaginal and perineal burns associated with unipolar RF resectoscopes can likely be minimized by careful attention to technique.
- Published
- 2005
24. Reported Pregnancies after Essure® Hysteroscopic Sterilization: A Retrospective Analysis of Pregnancy Reports Worldwide: 2001-2010
- Author
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Malcolm G. Munro, S. Veersema, Barbara S. Levy, and M.P.H. Vleugels
- Subjects
Gynecology ,medicine.medical_specialty ,Pregnancy ,Essure ,business.industry ,Obstetrics ,Retrospective analysis ,Obstetrics and Gynecology ,Medicine ,business ,medicine.disease ,Hysteroscopic sterilization - Published
- 2011
25. Virtual Reality Resectoscopic Simulator: Face Validation and Comparative Evaluation in an Educational Environment
- Author
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Malcolm G. Munro and D.P. Behling
- Subjects
business.industry ,Human–computer interaction ,Obstetrics and Gynecology ,Medicine ,Face (sociological concept) ,Virtual reality ,business ,Comparative evaluation ,Instructional simulation - Published
- 2009
26. Retrospective Analysis of 2008 Worldwide Pregnancy Reports in Women with Essure® Micro-Inserts
- Author
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L. Casas and Malcolm G. Munro
- Subjects
Pregnancy ,medicine.medical_specialty ,Essure ,business.industry ,Obstetrics ,medicine ,Retrospective analysis ,Obstetrics and Gynecology ,medicine.disease ,business - Published
- 2009
27. Uterine Sounding: Is There a Difference between Blind and Hysteroscopically-Directed Measurements?
- Author
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Malcolm G. Munro and Jacqueline M. Guerrero
- Subjects
Uterine sounding ,Depth sounding ,medicine.anatomical_structure ,business.industry ,Task force ,medicine ,Obstetrics and Gynecology ,Uterine cavity ,business ,Nuclear medicine - Abstract
Study Objective To evaluate the accuracy of traditional blind uterine sounding in measuring uterine cavity length (UCL), compared with measurement by hysteroscopic guidance. Design A cross-sectional descriptive study (Canadian Task Force classification III). Setting Academic multispecialty medical center. Patients Fifty-eight women undergoing elective hysteroscopic procedures. Intervention UCL measurement. Measurements UCL measurements were obtained by the traditional blind sounding technique and by hysteroscopically directed measurement. Hysteroscopic measurements were assumed to represent true uterine cavity length. Differences between the 2 measurements were calculated to analyze error and bias. Results Mean UCL for blind sounding and hysteroscopically directed measurements were 80.81 mm and 86.55 mm, respectively. The magnitude of error between measurements was >10 mm in 36.2% of cases, with underestimation of true UCL in 55.17% of cases. Conclusion True UCL is underestimated by blind sounding, and the frequency, magnitude, and direction of error may be greater than are clinically acceptable.
- Published
- 2008
28. 138: Intrauterine Ultrasound-Guided Radiofrequency Ablation of Fibroids: A Pilot Feasibility and Safety Study
- Author
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Malcolm G. Munro, A.I. Brill, José Gerardo Garza-Leal, James E. Coad, and J.D. Grossman
- Subjects
medicine.medical_specialty ,business.industry ,Radiofrequency ablation ,law ,Obstetrics and Gynecology ,Medicine ,Radiology ,business ,Ultrasound guided ,law.invention - Published
- 2007
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