Exposure of Surgeons to Magnetic Fields during Laparoscopic and Robotic Gynecologic Surgeries

Exposure of Surgeons to Magnetic Fields during Laparoscopic and Robotic Gynecologic Surgeries

Accepted Manuscript Exposure of Surgeons to Magnetic Fields during Laparoscopic and Robotic Gynecologic Surgeries Jee Soo Park, B.S., Jai Won Chung, B...

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Accepted Manuscript Exposure of Surgeons to Magnetic Fields during Laparoscopic and Robotic Gynecologic Surgeries Jee Soo Park, B.S., Jai Won Chung, B.S., Soo Beom Choi, M.S., Deok Won Kim, Ph.D., Young Tae Kim, M.D., Ph.D., Sang Wun Kim, M.D., Ph.D., Eun Ji Nam, M.D., Ph.D., Hee Young Cho, M.D. PII:

S1553-4650(15)00531-2

DOI:

10.1016/j.jmig.2015.07.009

Reference:

JMIG 2621

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 10 June 2015 Revised Date:

6 July 2015

Accepted Date: 10 July 2015

Please cite this article as: Park JS, Chung JW, Choi SB, Kim DW, Kim YT, Kim SW, Nam EJ, Cho HY, Exposure of Surgeons to Magnetic Fields during Laparoscopic and Robotic Gynecologic Surgeries, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.07.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Exposure of Surgeons to Magnetic Fields during Laparoscopic and Robotic Gynecologic

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Surgeries

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Jee Soo Park, B.S.1,2, Jai Won Chung, B.S.1,3, Soo Beom Choi, M.S.1,3, Deok Won Kim,

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Ph.D.1,3, Young Tae Kim, M.D., Ph.D.4, Sang Wun Kim, M.D., Ph.D.4, Eun Ji Nam, M.D.,

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Ph.D.4, Hee Young Cho, M.D.4

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Department of Medical Engineering, Yonsei University College of Medicine, Seoul, Korea

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Department of Medicine, Yonsei University College of Medicine, Seoul, Korea

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Graduate Program in Biomedical Engineering, Yonsei University, Seoul, Korea

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Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul,

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Korea

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Corresponding author:

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Deok Won Kim, Ph.D.

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Department of Medical Engineering, Yonsei University College of Medicine, CPO Box 8044,

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Seoul, Republic of Korea

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Tel: +82-10-3433-5402

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Fax: +82-2-364-1572

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E-mail: [email protected]

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Conflicts of Interest and Source of Funding: The authors report no conflict of interest.

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Précis

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This is the first study to measure and report on levels of exposure to extremely low-frequency

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magnetic fields to surgeon in during gynecologic surgeries.

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Study Objective: To measure and compare levels of extremely low-frequency magnetic field

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(ELF-MF) exposure to surgeons during laparoscopic and robotic gynecologic surgeries.

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Design: Prospective case-control study

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Design Classification: Canadian Task Force I

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Setting: Gynecologic surgeries at the Yonsei University Health System in Seoul, Korea from

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July to October in 2014.

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Study Subjects: 10 laparoscopic gynecologic surgeries and 10 robotic gynecologic surgeries.

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Intervention: The intensity of ELF-MF exposure to surgeons was measured every 4 seconds

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during 10 laparoscopic gynecologic surgeries and 10 robotic gynecologic surgeries using

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portable ELF-MF measuring devices with logging capability.

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Measurement and Main Results: The mean ELF-MF exposures were 0.1 ± 0.1 mG for

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laparoscopic gynecologic surgeries and 0.3 ± 0.1 mG for robotic gynecologic surgeries. ELF-

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MF exposure levels to surgeons during robotic gynecologic surgery were significantly higher

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than those during laparoscopic gynecologic surgery (p < 0.001) after adjustment for duration

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of measurement.

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Conclusion: The present study demonstrated low levels of ELF-MF exposure to surgeons

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during robotic gynecologic surgery and conventional laparoscopic surgery, hoping to relieve

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concerns on the hazards of magnetic field exposure posed to surgeons and hospital staff.

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Keywords: Magnetic field hazard; Robotic gynecologic surgery; Laparoscopic gynecologic

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surgery; da Vinci Surgical System

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Introduction Electronic devices offer humans a number of conveniences. However, there are concerns

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for the hazards electromagnetic fields pose to human health. Electromagnetic fields are

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composed of electric and magnetic fields (MFs), each of which influence our bodies in

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different ways. Conducting objects, including human skin, can easily shield our bodies from

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electric fields, while MFs cannot be so easily protected against [1]. Therefore, researchers

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have set out to investigate the effects of MFs on humans, as MFs cannot be readily blocked

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[2].

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Wertheimer and Leeper [3] first reported on increases in the development of childhood

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cancer in association with the distance of their house to power lines. This research provoked

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many groups to outline associations between MF and its biological effects. Among the

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spectrum of MFs, extremely low-frequency (ELF)-MFs are emitted at frequencies from 3Hz

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to 3000Hz; power lines and electric appliances typically use frequencies of 50 or 60Hz [2].

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ELF-MFs are classified as possibly carcinogenic to humans (Group 2B) by the International

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Agency for Research on Cancer (IARC) [4]. Guidelines for limiting exposure among the

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general public to MFs, issued by the International Commission on Non-Ionizing Radiation

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Protection (ICNIRP) in 2010, restricted MF exposure to 2 Gauss (G) at 60 Hz for any length

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of time to limit current density to prevent effects on nervous system function [5]. However,

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many epidemiologic studies reported that 2 mG is the maximum level at which it is

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considered safe for long-term exposure [6-8]. The Swedish Board for Technical Accreditation

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has also issued guidelines for computer monitors that restrict computer monitors from

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producing ELF-MFs of more than 2 mG at 30 cm [9].

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The associations between ELF-MF and diseases have been reported by many groups.

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Sastre et al. [10] and Savitz et al. [11] demonstrated that ELF-MF alters human cardiac

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rhythm and arrhythmia-related cardiovascular disease, respectively. ELF-MF has also been

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shown to be associated with breast cancer [12-15]. The most recent study by Davanipour et al.

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in 2014 described an association between ELF-MF and cognitive dysfunction [16]. Nevertheless, despite increased interest on the effects of ELF-MFs on human health, not

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many studies have been conducted to assess ELF-MF levels in hospitals. As many electrical

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devices and equipments are used and becoming essential for treatment and diagnosis of

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diseases, surgeons and hospital staffs have been exposed to these devices producing ELF-MF.

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However, a few studies have been considered the hazard of ELF-MFs to surgeons and

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hospital staffs. Two studies have reported on ELF-MF exposure levels posed to

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anesthesiologists in operating rooms by spot measurement and periodic measurement during

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surgery, respectively [17-18], and ELF-MFs above 2 mG were measured from infant

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warming systems and incubators in neonatal intensive care units by Riminesi et al. [19].

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Meanwhile, laparoscopic and robotic surgeries, which provide benefits of better surgical

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outcomes and efficiency, also expose surgeons and hospital staff to ELF-MFs. Due to the

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characteristics of limited spaces in the operating room with full of medical apparatus, the

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ELF-MF in operating room was expected be high. Moreover, since surgeons and hospital

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staffs stay in the operation room for a long period of time, the long exposure time of ELF-MF

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would increase the hazards of ELF-MFs. Thus, we set out to measure and compare levels of

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ELF-MF exposure at the surgeon’s heart during laparoscopic gynecologic surgery and robotic

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gynecologic surgery using the IS3000 da Vinci Si Surgical System (all from Intuitive Surgical,

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Inc., Sunnyvale, CA). By comparing the ELF-MF during laparoscopic and robotic

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gynecologic surgeries with the stringent suggestion of 2 mG, we identified the hazards of

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exposure in surgeons to ELF-MF in the operating rooms.

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Methods Levels of ELF-MF exposure to surgeons in 10 laparoscopic and 10 robotic gynecologic

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surgeries were measured at the Yonsei University Health System (YUHS) in Seoul, Korea. In

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all robotic gynecologic surgeries, the da Vinci Surgical System was used. To minimize the

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confounding factors, almost the same equipments, such as electrosurgical units, were used in

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laparoscopic and robotic surgery, except the robot system. In gynecologic surgery,

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myomectomy, hysterectomy, and salpingo-oophorectomy were chosen. All subjects were

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informed of the purpose and procedures of the experiments and provided written consent

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before joining the study. The Institutional Review Board of the YUHS approved the study

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protocol (project no: 4-2014-0398) on July 24, 2014.

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To measure levels of ELF-MF exposure to surgeons during the laparoscopic and robotic

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gynecologic surgeries, an EMDEX Lite (Enertech Consultants, Campbell, CA, USA) portable

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measuring device was fitted at the position of each surgeon’s heart to periodically measure

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the intensities of ELF-MFs during surgery. This portable device can measure ELF-MFs

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between 40 and 1000 Hz, ranging from 0.1 to 700.0 mG, with a resolution of 0.1 mG and an

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accuracy of ± 2%; the device samples and stores ELF-MF intensity data inside the device

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every 4 s. Exposure level data for each surgeon, from the beginning to the end of each surgery,

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were retrieved by connecting the device to a personal computer equipped with EMCALC

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2000 (Enertech Consultants) analysis and graphical software.

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The mean and standard deviation of ELF-MF exposures during each surgery were

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obtained from EMCALC 2000. The proportions of exposure levels equal to or exceeding 2

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mG in each surgery were also obtained. The Mann-Whitney U test was used to compare the

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mean exposures to ELF-MFs for each surgeon during laparoscopic and robotic gynecologic

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surgery. We used analysis of covariance (ANCOVA) to adjust for confounding factors

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affecting ELF-EMF exposures. All reported P-values are two-sided; those under 0.05 were

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considered statistically significant. All statistical analyses were performed with the Statistical

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Package for the Social Sciences software (version 20, IBM SPSS Statistics; IBM Corp.,

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Armonk, NY, USA).

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Results

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Table 1 shows details, including exposure levels to ELF-MFs, on the laparoscopic and

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robotic gynecologic surgeries. Table 2 shows comparisons of the mean ELF-MF exposures of

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surgeons in the laparoscopic and robotic gynecologic surgeries. In the 10 laparoscopic and 10

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robotic gynecologic surgeries, the mean exposures to ELF-MFs were 0.1 ± 0.1 mG for

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laparoscopic gynecologic surgeries, with a measuring time between 0.8 and 2.1 hours, and

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0.3 ± 0.1 mG for robotic gynecologic surgeries, with a measuring time between 1.3 and 2.6

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hours. There were almost no level changesof ELF-MF intensity with time both in

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laparoscopic and robotic gynecologic surgeries. The ELF-MF exposure level when not

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performing surgery was 0.08 ± 0.1 mG. The ELF-MF exposure levels to surgeons during

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robotic gynecologic surgery were significantly higher than those during laparoscopic

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gynecologic surgery (p < 0.001); nonetheless, levels for both types of surgery were much

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lower than the stringent recommendation of 2 mG for considering ELF-MF exposure

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hazardous. In addition, the ELF-EMF exposure levels were significantly different after

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adjustment for the confounding factor (duration of measurement) by ANCOVA (Table 2). The

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proportions of exposure levels equal to or greater than 1 mG and below 2 mG in the

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laparoscopic and robotic gynecologic surgeries were 0.05% and 0.23%, respectively. The

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proportions of exposure levels below 1 mG were 99.93% for laparoscopic gynecologic

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surgeries and 99.76% for robotic gynecologic surgeries.

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Discussion Surgeons and hospital staff are unprotected against potentially hazardous levels of ELF-

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MF exposure in operating rooms equipped with numerous electronic devices in an enclosed

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area. Nonetheless, this is the first study to provide data on the intensities of ELF-MF

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exposure during laparoscopic and robotic gynecologic surgery. Herein, while ELF-MF

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exposure levels during robotic gynecologic surgery were significantly higher than those

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during laparoscopic gynecologic surgery after adjustment for the confounding factor

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(duration of measurement), the levels for both types of surgery were much lower than the

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recommended level of 2 mG for considering ELF-MF exposure hazardous, which is

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considered stringent by many studies [6-9]. Therefore, there is no limit of time for ELF-MFs

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to become a risk during one surgery since ELF-MFs were much lower than the recommended

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level of 2 mG.

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In our study, the mean levels of ELF-MF exposure were quite low at 0.1 ± 0.1 mG for

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laparoscopic gynecologic surgeries and 0.3 ± 0.1 mG for robotic gynecologic surgeries. The

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proportions of exposure levels equal to or exceeding 2 mG were 0.02% for laparoscopic

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gynecologic surgeries and 0.01% for robotic gynecologic surgeries. The World Health

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Organization reported a mean MF exposure level of 1.1 mG in homes across North America

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[20], much higher than the mean MF exposures to surgeons in the laparoscopic and robotic

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surgeries.

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The levels of ELF-MF exposure during robotic gynecologic surgeries were significantly

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higher than those during laparoscopic gynecologic surgeries (p < 0.001). The reason why

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exposure levels were significantly higher during robotic gynecologic surgeries than

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laparoscopic gynecologic surgeries may be related to the distance from the master console to

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the surgeons. During robotic gynecologic surgery, surgeons sit close to the master console

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with their heads placed on the monitor of the master console, where the intensities of ELF-

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MFs would be high. During laparoscopic gynecologic surgeries, surgeons do not sit close to

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electronic laparoscopic surgery equipment. Since MFs rapidly decrease in intensity to

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background levels (no greater than that found in nature) at a distance of 3 to 4ft from an

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electric appliance [2], ELF-MF exposure levels during laparoscopic gynecologic surgery

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would be near to those at background levels. We found that ELF-MF intensities from the

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master console of the robot system at the position of the surgeon’s heart were approximately

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0.3 mG. Although 0.3 mG is not a considerably high level of ELF-MF exposure, we do not

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know the consequences of long-term accumulation effects of low intensity ELF-MF exposure.

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When we consider that the surgery time is usually longer than 1 hour and surgeons do not

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move much during surgery, the accumulation of ELF-MF exposure cannot be overlooked.

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It would be important to measure ELF-MF exposure levels during open surgery. For

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reference, we have once measured the ELF-MFs of open surgery, which was 0.09 ± 0.1 mG,

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slightly lower than both laparoscopic and robotic surgery. This result might be due to the

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reason that open surgery uses less number of electronic equipments. However, we could not

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be certain since there were too many confounding factors. It was difficult to minimize the

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confounding factors when comparing open surgery with laparoscopic or robotic surgery,

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since the devices used in open surgery are too much different from laparoscopic and robotic

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surgery. Therefore, this study focused on comparing between laparoscopic and robotic

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gynecologic surgeries.

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We measured ELF-MF levels at the position of the surgeons’ hearts since numerous

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studies have reported on the hazardous effects of ELF-MFs on the heart [10,11]. While the

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association of ELF-MFs with other diseases, such as breast cancer and brain associated

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diseases, are also well known [12,16,21], attachment of devices at the position of the heart

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was less distracting to surgeons than attaching the devices on other parts of the body.

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Measurement of ELF-MFs at the brain would be more meaningful since the ELF-MFs

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produced by the monitor that operator looks through during surgery would be comparatively

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high; however, this was not possible because the surgeons felt that it might drop during the

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surgeries. Moreover, the measurement device was too heavy to attach to the head. Therefore,

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the position of the heart was the only meaningful place along the body to attach the

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measurement device without interrupting the surgeons from carrying out the surgeries.

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Although this study provides basic reference data on ELF-MFs during laparoscopic and

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robotic gynecologic surgeries for the first time, a few limitations warrant consideration. First,

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the arrangement of the electronic devices and equipment were not the same for every surgery.

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However, we suspect that the difference would be too small to significantly affect the

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intensities of the ELF-MFs. Second, it would have been better if we had measured the ELF-

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MFs at surgeons’ heads; however, the surgeons would felt this would be an inconvenience

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during surgery. Thus, as this study was designed to evaluate ELF-MF levels in the operating

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room and not to interrupt or cause any disturbance during the operation that would affect any

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of the results of the surgeries, the position of the heart was chosen. Third, results in this study

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apply only to gynecologic surgeries of myomectomy, hysterectomy, and salpingo-

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oophorectomy and may not be applicable to other surgeries from other departments which

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may have different intensities of the ELF-MFs.

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Conclusions

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Levels of exposure to ELF-MFs during robotic gynecologic surgery were significantly

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higher than those during laparoscopic gynecologic surgery. This may be due to the short

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distance of the surgeon from the master console. Although levels of ELF-MF exposure for

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both laparoscopic and robotic gynecologic surgery were considerably lower than 2 mG,

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investigation of exposure times and the effect of long-term exposure of ELF-MFs to surgeons

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and hospital staff during surgery is needed. Nevertheless, this is the first study to demonstrate

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that exposure to ELF-MFs during robotic gynecologic surgery or conventional laparoscopic

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surgery does not pose a hazard to surgeons or hospital staff. We believe that this study is

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beginning to answer the question as to the importance of intra-operative exposure to ELF-

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MFs, and future long-term studies are necessary to truly answer this question.

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Acknowledgments

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This research was supported by a grant from the Basic Science Research Program

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through the National Research Foundation of Korea (NRF) funded by the Ministry of

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Education, Science and Technology (MEST) (NRF-2010-0022374).

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Table 1: Levels of extremely low-frequency magnetic field exposure to surgeons in the 10

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laparoscopic and the 10 robotic gynecologic surgeries

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Table 2: Comparisons of the mean extremely low-frequency magnetic field exposures of

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surgeons in the laparoscopic and the robotic gynecologic surgeries

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ACCEPTED MANUSCRIPT Table 1: Levels of extremely low-frequency magnetic field exposure to surgeons in the 10 laparoscopic and the 10 robotic gynecologic surgeries Number of

MF exposure (mG)

measurement (h)

Measurements*

Min

LGS 1

0.8

710

0.1

LGS 2

2.1

1934

0.1

LGS 3

1.6

1453

0.1

LGS 4

1.1

953

0.1

LGS 5

1.3

1201

LGS 6

1.3

1133

LGS 7

1.7

1511

LGS 8

1.5

LGS 9

1.4

LGS 10

1.1

RGS 1

2.4

RGS 2

1.4

RGS 3

Max

Mean ± SD

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Duration of

1.5

0.2 ± 0.1

1.1

0.2 ± 0.1

1.1

0.1 ± 0.1

1.3

0.1 ± 0.1

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Surgery

2.6

0.2 ± 0.1

0.1

0.9

0.1 ± 0.1

0.1

0.6

0.1 ± 0.1

1386

0.1

0.5

0.1 ± 0.1

1227

0.1

0.6

0.1 ± 0.1

979

0.1

0.6

0.1 ± 0.1

2158

0.1

2.6

0.3 ± 0.1

1231

0.1

0.8

0.3 ± 0.1

2.4

2189

0.1

1.9

0.4 ± 0.1

RGS 4

2.6

2333

0.1

1.7

0.3 ± 0.1

RGS 5

1.7

1525

0.2

0.6

0.3 ± 0.1

RGS 6

1.4

1287

0.1

1.0

0.4 ± 0.1

2.0

1812

0.1

0.6

0.4 ± 0.1

1.4

1298

0.2

0.7

0.4 ± 0.1

RGS 9

1.4

1242

0.1

1.1

0.3 ± 0.1

RGS 10

1.3

1130

0.2

0.6

0.3 ± 0.1

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RGS 7

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MF = magnetic field, LGS = laparoscopic gynecologic surgery, RGS = robotic gynecologic surgery. *

The number of measurements was counted on the basis of repeated measurements every 4 s within the designated time.

ACCEPTED MANUSCRIPT Table 2: Comparisons of the mean extremely low-frequency magnetic field exposures of surgeons in the laparoscopic and the robotic gynecologic surgeries Laparoscopic

Robotic gynecologic

gynecologic surgery

surgery (n=10)

(n=10) Mean MF exposure

0.1 ± 0.1

0.3 ± 0.1

1.4 ± 0.4

1.8 ± 0.5

(mG) Duration of

ANCOVA = analysis of covariance, MF = magnetic field.

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Data are shown as mean ± SD. *

P-value calculated using the Mann-Whitney U test.

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P-value for ANCOVA adjusted for duration of measurement.

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P†

<0.001

<0.001

0.073

-

SC

measurement (h)

P*

RI PT

Value

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

http://www.AAGL.org/jmig-22-6-JMIG-D-15-00356