Vaginal Energy-Based Devices.

This clinical consensus statement on vaginal energy-based devices (EBDs) reflects statements drafted by content experts from the American Urogynecologic Society's EBD writing group. The American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus.

Impact of Obesity on Surgeon Ergonomics in Robotic and Straight-Stick Laparoscopic Surgery.

STUDY OBJECTIVE: Work-related musculoskeletal symptoms (WMSs) are reported to be increasing in surgeons performing minimally invasive procedures. Therefore, we investigated the use of inertial measurement units (IMUs) and electromyography (EMG) sensor recorders to record real-time information on the muscle movement/activity required to perform training exercises in simulated in normal and high body mass index (BMI) models. DESIGN: Prospective study. SETTING: University hospital. PARTICIPANTS: Four consultant gynecologic oncology surgeons experienced in complex straight-stick (SS) laparoscopic and robotically assisted (RA) surgery. INTERVENTIONS: Three exercises (hoops onto pegs and wire chase) using SS and RA surgery on 2 abdominal models: normal BMI and high BMI. MEASUREMENTS AND MAIN RESULTS: We measured time to complete exercise and surgeon muscle movement/activity. The time to complete all exercises was significantly lower for RA surgery as compared with SS laparoscopy (p <.05 or better). The movement of the surgeons' core was significantly greater in high BMI SS laparoscopy compared with normal BMI SS laparoscopy for exercises 1 and 2 (p <.001). Muscle usage, as determined by EMG peak, was significantly higher in normal BMI SS laparoscopy and even higher in high BMI SS laparoscopy but was generally flat for all normal and high BMI RA surgery exercises (p <.05 or better). CONCLUSION: Detailed real-time information can be collected through IMUs/EMG sensors. Our results indicate that RA surgery requires less surgeon movements and muscle activity to complete tasks compared with SS laparoscopy, particularly in a high BMI model. The implications of these results are that RA surgery in high BMI patients may therefore have less physical impact on the surgeon compared with SS laparoscopy and may result in lower WMS rates.

The Morcellation "Debate" and the FDA 510(k) Process-A Call for Further Reform.

IMPORTANCE: Few gynecologic surgeons understand the mechanism by which surgical instruments are approved for human use and marketing or do they appreciate the central role they play in postmarket surveillance and reporting after instruments have come to market. OBJECTIVE: Using the experience with the uterine morcellator, this review will detail the Food and Drug Administration (FDA) system for approving surgical instruments and the potential pitfalls of this process. EVIDENCE ACQUISITION: Literature review and public documents from the FDA. RESULTS: The FDA 510(k) approval process for surgical instruments relies largely on postmarket surveillance as exemplified by the uterine power morcellator, which was approved before sufficient evidence was available regarding its potential harms. CONCLUSIONS: The current system currently transfers the responsibility of ensuring safety and efficacy to the public, patients, and providers. To minimize potential harm, the FDA needs to incorporate a greater standard of evidence into its framework for the approval and regulation of medical devices. The burden of these requirements should be borne at least in part by the companies bringing equipment to market. RELEVANCE: It is incumbent on all surgeons to be vigilant in their objective critical assessment of new instrumentation and report their outcomes after they come to market.

Experiencias adquiridas por los residentes de Ginecología y Obstetricia en la instrumentación obstétrica del parto / Experiences acquired by Gynaecology and Obstetrics residents regarding delivery obstetrics instrumentation

Introducción: Los obstetras siempre han tratado de sujetar la cabeza del feto de la manera más segura posible para acelerar el parto y reducir el difícil trabajo de la mujer. La historia del uso de instrumentos obstétricos para facilitar el parto (ya sean fórceps o espátulas) es una parte pintoresca y particular de la historia de la medicina. Objetivos: Identificar la experiencia adquirida por los residentes en la instrumentación obstétrica. Métodos: Para cumplir los objetivos propuestos se revisó el plan temático de la residencia de Ginecobstetricia y posteriormente fueron seleccionados los aspectos referidos al tema en estudio. Resultados: Los resultados encontrados a partir de las encuestas realizadas y los datos aportados por los tutores de formación y la revisión de los libros de partos aportaron el nivel de aprendizaje de los residentes. Conclusiones: Se aprecia en los estudiantes demora en la aprehensión de los conocimientos relacionado con la instrumentación obstétrica(AU)

Introduction: Obstetricians have always tried to hold the fetus head as safely as possible to accelerate delivery and reduce the women's difficult work. The history of usage of obstetric instruments to facilitate labor (whether forceps or spatulas) is a colorful and particular passage in the history of medicine. Objectives: To identify the residents' acquired experience regarding the obstetric instrumentation, for which we decided to determine their received practical theoretical training. Methods: In order to meet the proposed objectives, we reviewed the system of contents for the Gynecology residence and, thereafter, we selected the aspects regarding the subject under study. Results: The results obtained from the surveys conducted and the data provided by the training professors and the review of delivery books contributed to the residents' level of learning. Conclusions: The students show delay in the apprehension of knowledge regarding obstetric instrumentation(AU)

Motion control skill assessment based on kinematic analysis of robotic end-effector movements.

BACKGROUND: The performance of robotic end-effector movements can reflect the user's operation skill difference in robot-assisted minimally invasive surgery. This study quantified the trade-off of speed-accuracy-stability by kinematic analysis of robotic end-effector movements to assess the motion control skill of users with different levels of experience. METHODS: Using 'MicroHand S' system, 10 experts, 10 residents and 10 novices performed single-hand test and bimanual coordination test. Eight metrics based on the movements of robotic end-effectors were applied to evaluate the users' performance. RESULTS: In the single-hand test, experts outperformed other groups except for movement speed; in the bimanual coordination test, experts also performed better except for movement time and movement speed. No statistically significant difference in performance was found between residents and novices. CONCLUSIONS: The kinematic differences obtained from the movements of robotic end-effectors can be applied to assess the motion control skill of users with different skill levels.

A Classical Wooden Vaginal Speculum Mentioned in Old Medical Manuscripts.

The subject of this paper is the story of an ancient medical instrument. This instrument is a wooden vaginal speculum used in classical and Islamic medicine. Its drawings can be found in Abulcasis al-Zahrawi's and Serefeddin Sabuncuoglu's illustrated books of surgery.

Design and testing of a phantom and instrumented gynecological applicator based on GaN dosimeter for use in high dose rate brachytherapy quality assurance.

PURPOSE: High dose rate brachytherapy (HDR-BT) is widely used to treat gynecologic, anal, prostate, head, neck, and breast cancers. These treatments are typically administered in large dose per fraction (>5 Gy) and with high-gradient-dose-distributions, with serious consequences in case of a treatment delivery error (e.g., on dwell position and dwell time). Thus, quality assurance (QA) or quality control (QC) should be systematically and independently implemented. This paper describes the design and testing of a phantom and an instrumented gynecological applicator for pretreatment QA and in vivo QC, respectively. METHODS: The authors have designed a HDR-BT phantom equipped with four GaN-based dosimeters. The authors have also instrumented a commercial multichannel HDR-BT gynecological applicator by rigid incorporation of four GaN-based dosimeters in four channels. Specific methods based on the four GaN dosimeter responses are proposed for accurate determination of dwell time and dwell position inside phantom or applicator. The phantom and the applicator have been tested for HDR-BT QA in routine over two different periods: 29 and 15 days, respectively. Measurements in dwell position and time are compared to the treatment plan. A modified position-time gamma index is used to monitor the quality of treatment delivery. RESULTS: The HDR-BT phantom and the instrumented applicator have been used to determine more than 900 dwell positions over the different testing periods. The errors between the planned and measured dwell positions are 0.11 ± 0.70 mm (1σ) and 0.01 ± 0.42 mm (1σ), with the phantom and the applicator, respectively. The dwell time errors for these positions do not exhibit significant bias, with a standard deviation of less than 100 ms for both systems. The modified position-time gamma index sets a threshold, determining whether the treatment run passes or fails. The error detectability of their systems has been evaluated through tests on intentionally introduced error protocols. With a detection threshold of 0.7 mm, the error detection rate on dwell position is 22% at 0.5 mm, 96% at 1 mm, and 100% at and beyond 1.5 mm. On dwell time with a dwell time threshold of 0.1 s, it is 90% at 0.2 s and 100% at and beyond 0.3 s. CONCLUSIONS: The proposed HDR-BT phantom and instrumented applicator have been tested and their main characteristics have been evaluated. These systems perform unsupervised measurements and analysis without prior treatment plan information. They allow independent verification of dwell position and time with accuracy of measurements comparable with other similar systems reported in the literature.

Bits and pieces: the ethics of uterine morcellation.

Intensive media and policy attention has been focused on the ongoing controversy surrounding uterine morcellation in gynecologic surgery. What has been missing from this impassioned discourse is an objective analysis of the ethical implications of uterine power morcellation in gynecologic surgery. This article discusses competing ethical duties of physicians, industry, the U.S. Food and Drug Administration, and the media to develop a more robust and nuanced understanding of informed consent for the use of morcellation in benign gynecologic surgery. Ultimately, as physicians, we must remain steadfast in our dedication to the use of evolving technologies to better patient health in a safe and ethical manner that is well-studied, informed, and implemented with appropriate training and precautions.

Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial.

OBJECTIVE: Although previous studies have demonstrated that a variety of local anesthetics are effective to decrease pain associated with tenaculum placement, no studies directly compare an injection with a topical anesthetic. The objective of this study was therefore to compare mean pain scores with tenaculum placement after an intracervical lidocaine injection or topical lidocaine gel. STUDY DESIGN: A randomized, single-blinded trial of women presenting for office gynecologic procedures that required a tenaculum. Women aged 18 years or older were randomized to receive either a 1% lidocaine intracervical injection or topical application of 2% lidocaine gel to the cervix immediately prior to tenaculum placement. The primary outcome was pain at the time of tenaculum placement, measured on a 100 mm Visual Analog Scale. Secondary outcomes included pain with the intervention and satisfaction with tenaculum placement. RESULTS: Seventy-four women were enrolled and randomized; 35 subjects in each group met criteria for analysis. The two groups had similar socio-demographic characteristics. Women who received the injection had lower mean pain levels at tenaculum placement [12.3 mm (S.D. 17.4 mm) versus 36.6 mm (S.D. 23.0 mm), p<.001] but higher mean pain levels with study drug application [20.4 mm (S.D. 19.4 mm) versus 5.9 mm (S.D. 8.6 mm), p<.001]. Satisfaction with tenaculum placement was similar for the two groups. CONCLUSION: Mean pain with tenaculum placement is lower after receiving a lidocaine injection than after receiving a topical lidocaine gel. Satisfaction with tenaculum placement is similar with both interventions.

Electromechanical morcellators in minimally invasive gynecologic surgery: an update.

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.

Novel application of a fecal management system for vaginal use in radiotherapy-associated rectovaginal fistula.

While highly effective for treating certain gynecologic malignancies, radiotherapy carries known risks, including fistula formation. We report a 75-year-old female with advanced cervical carcinoma who was provided a vaginally placed fecal management system after developing a rectovaginal fistula following primary treatment with chemoradiation. This report presents and discusses a novel method to palliate symptomatic RVFs in advanced-stage cancer.

[Robotic surgery in gynecologic oncology: Retrospective and comparative study with laparotomy and laparoscopy]. / Chirurgie robotique en cancérologie gynécologique: étude rétrospective comparative avec la laparotomie et la cœlioscopie traditionnelle.

OBJECTIVES: To compare robot-assisted laparoscopy with conventional laparoscopy and laparotomy in gynecologic oncology. PATIENTS AND METHODS: This is a monocentric retrospective study enrolling 92 patients who underwent a standard or radical hysterectomy (with parametrectomy) with or without pelvic lymphadenectomy between January 2008 and December 2010. All patients were diagnosed for a cervical or endometrial cancer. Laparotomy was performed for 33 patients, conventional laparoscopy for 20 patients, and robot-assisted laparoscopy for 39 patients. The main parameter was the length of hospital stay in the three groups. RESULTS: Length of hospital stay significantly decreased in the robotic group in comparison with the laparotomic group (median 5 and 8 days respectively, P<0.0001), but no differences were found between the robotic and laparoscopic groups (P=0.77). Intraoperative blood loss was lower in the robotic group. Intraoperative complications and lymph nodes removed were equal in the three groups. Regarding the data recorded, there were no significant differences between conventional and robotic laparoscopy. Hysterectomies performed after pelvic radiation, which were all made by laparotomy before the robot's arrival, were all performed with robotic laparoscopy since its arrival. CONCLUSION: Robotic surgery allows a reduced length of hospital stay and a lower blood loss in comparison with laparotomy, without any worse oncologic results. Robotic surgery changed our practice, especially hysterectomy after pelvic radiation, performed by laparotomy before.

Development of the M. D. Anderson Cancer Center gynecologic applicators for the treatment of cervical cancer: historical analysis.

PURPOSE: To provide historical background on the development and initial studies of the gynecological (gyn) applicators developed by Dr. Gilbert H. Fletcher, a radiation oncologist and chairperson from 1948 to 1981 of the department at the M.D. Anderson Hospital (MDAH) for Cancer Research in Houston, TX, and to acknowledge the previously unrecognized contribution that Dr. Leonard G. Grimmett, a radiation physicist and chairperson from 1949 to 1951 of the physics department at MDAH, made to the development of the gynecological applicators. METHODS AND MATERIALS: We reviewed archival materials from the Historical Resource Center and from the Department of Radiation Physics at The University of Texas M. D. Anderson Cancer Center, as well as contemporary published papers, to trace the history of the applicators. CONCLUSIONS: Dr. Fletcher's work was influenced by the work on gynecologic applicators in the 1940s in Europe, especially work done at the Royal Cancer Hospital in London. Those efforts influenced not only Dr. Fletcher's approach to the design of the applicators but also the methods used to perform in vivo measurements and determine the dose distribution. Much of the initial development of the dosimetry techniques and measurements at MDAH were carried out by Dr. Grimmett.

[Robotic surgery in gynecology]. / Zastosowanie robotów w chirurgii ginekologicznej.

Introduction of robotic surgery in the first decade of the 21 century was one of the biggest breakthroughs in surgery since the introduction of anesthesia. For the first time in history the surgeon was placed remotely from the patient and was able to operate with the device that has more degrees of freedom than human hand. Initially developed for the US Military in order to allow surgeons to be removed from the battlefield, surgical robots quickly made a leap to the mainstream medicine. One of the first surgical uses for the robot was cardiac surgery but it is urology and prostate surgery that gave it a widespread popularity Gynecologic surgeons caught on very quickly and it is estimated that 31% of hysterectomies done in the United States in 2012 will be done robotically. With over half a million hysterectomies done each year in the US alone, gynecologic surgery is one of the main driving forces behind the growth of robotic surgery Other applications in gynecology include myomectomy oophorectomy and ovarian cystectomy resection of endometriosis and lymphadenectomy Advantages of the surgical robot are clearly seen in myomectomy The wrist motion allows for better more precise suturing than conventional "straight stick" laparoscopy The strength of the arms allow for better pulling of the suture and the third arm for holding the suture on tension. Other advantage of the robot is scaling of the movements when big movement on the outside translates to very fine movement on the inside. This enables much more precise surgery and may be important in the procedures like tubal anastomosis and implantation of the ureter Three-dimensional vision provides excellent depth of field perception. It is important for surgeons who are switching from open surgeries and preliminary evidence shows that it may allow for better identification of lesions like endometriosis. Another big advantage of robotics is that the surgeon sits comfortably with his/her arms and head supported. This results in much less fatigue and therefore increases precision and potentially may decrease the number of medical errors. The eyes of the surgeon are directed at where the hands should be, which is more natural, allows for a more natural body position and mimics open surgery Robot also enables better teaching, especially when two consoles are used. The surgeon and the student may be either sharing the instruments with two consoles or switching between one another. In a situation where the student operates, the surgeon can use the telestation to teach. Robotic simulator attached to one of the consoles allows students to practice after hours. In summary surgical robot is a great tool, especially in gynecology but also in urology cardiac surgery general surgery and laryngology The device will evolve and most likely with time will eliminate laparoscopy

Efficacy of a novel educational curriculum using a simulation laboratory on resident performance of hysteroscopic sterilization.

OBJECTIVE: To assess whether a novel educational curriculum using a simulation teaching laboratory improves resident knowledge, comfort with, and surgical performance of hysteroscopic sterilization. DESIGN: An educational prospective, pretest/posttest study. SETTING: The Montefiore Institute of Minimally Invasive Surgery Laboratory. PATIENT(S)/SUBJECT(S): Thirty-four OB/GYN residents in an academic medical center. INTERVENTION(S): Hysteroscopic sterilization simulation laboratory and a brief didactic lecture. MAIN OUTCOME MEASURE(S): Differences in scores on validated skill assessment tools: Task specific checklist, Global Rating Scale (GRS), pass fail assessment, and a multiple-choice examination to evaluate knowledge and attitude. RESULT(S): In the entire cohort improvements were observed on all evaluation tools after the simulation laboratory, with 31% points (SD+/-11.5, 95% confidence interval [CI] 27.3-35.3) higher score on the written evaluation; 63% points (SD+/-15.7, 95% CI 57.8-68.8) higher score on the task specific checklist; and 54% points (SD+/-13.6, 95% CI 48.8-58.3) higher score on the GRS. Higher PGY status was correlated with better pretest performance, but was not statistically significant in posttest scores. Residents reported an improvement in comfort performing the procedure after the laboratory. CONCLUSION(S): Simulation laboratory teaching significantly improved resident knowledge, comfort level, and technical skill performance of hysteroscopic sterilization.

Comparison of a new reusable gynecologic laparoscopic electric morcellator with a disposable morcellator: a preliminary trial.

We compared the efficiency and safety of a newly developed reusable morcellator (Olympus VarioCarve) with that of a disposable morcellator (GyneCare Morcellex) for gynecologic laparoscopic surgery. In group 1 (n=15 patients; 11 myomectomies and 4 supracervical hysterectomies), the laparoscopic disposable morcellator was used, and in group 2 (n=14; 11 myomectomies and 3 supracervical hysterectomies), the reusable morcellator was used. There were no statistical differences in total tissue weight. Morcellating time was significantly shorter in group 2, and the rate of morcellation was significantly greater in group 2. Significantly fewer and longer pieces of tissue were removed with the reusable morcellator. No iatrogenic organ damage was observed.