Accepted Manuscript Comparison of Postural Ergonomics Between Laparoscopic and Robotic Sacrocolpopexy: a Pilot Study Megan E. Tarr, MD, MS Sam J. Brancato, MD Jacqueline A. Cunkelman, MD, MPH Anthony Polcari, MD Benjamin Nutter, MS Kimberly Kenton, MD, MS PII:

S1553-4650(14)01440-X

DOI:

10.1016/j.jmig.2014.10.004

Reference:

JMIG 2398

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 26 August 2014 Revised Date:

28 September 2014

Accepted Date: 7 October 2014

Please cite this article as: Tarr ME, Brancato SJ, Cunkelman JA, Polcari A, Nutter B, Kenton K, Comparison of Postural Ergonomics Between Laparoscopic and Robotic Sacrocolpopexy: a Pilot Study, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2014.10.004. 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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Comparison of Postural Ergonomics Between Laparoscopic and Robotic Sacrocolpopexy: a Pilot Study

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Megan E. TARR, MD, MS1,2; Sam J. BRANCATO, MD2; Jacqueline A. CUNKELMAN, MD, MPH1,2; Anthony POLCARI, MD2; Benjamin NUTTER, MS3; Kimberly KENTON MD, MS1,2

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1. Division of Female Pelvic Medicine & Reconstructive Surgery, Departments of Obstetrics/Gynecology and Urology, Stritch School of Medicine, Loyola University Chicago, Chicago, IL 2. Department of Urology, Stritch School of Medicine, Loyola University Chicago, Chicago, IL 3. Section of Biostatistics, Qualitative Health Sciences, Cleveland Clinic Foundation

Disclosures: Megan E. Tarr: received reimbursement for travel from Intuitive Surgical, Inc. for curriculum development meetings Financial support: none

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Meeting information: Accepted for an oral poster presentation at the 39th Annual Scientific Meeting of the Society of Gynecologic Surgeons in Charleston, SC, April 8-10, 2013

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Corresponding author: Megan E. Tarr, MD, MS Section of Urogynecology and Pelvic Reconstructive Surgery Department of Obstetrics and Gynecology 9500 Euclid Ave, A-81 Cleveland, Ohio 44195 Office phone: 216-444-9391, Office fax: 216-636-5129 Email: [email protected]

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Precis:

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Robotic surgery may offer ergonomic benefits over laparoscopy and reduce

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neck, shoulder, and back discomfort.

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Abstract:

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Study Objective:

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To compare resident, fellow and attending urologic & gynecologic surgeons’

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musculoskeletal and mental strain during laparoscopic and robotic

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sacrocolpopexy.

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Design: Prospective cohort II-2

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Setting: Academic medical center

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Patients: Patients who underwent robotic or laparoscopic sacrocolpopexy from

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October 2009- January 2011

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Intervention: The Body Part Discomfort (BPD) Survey was completed prior to

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cases, and NASA Task Load Index (TLX) and BPD were completed following

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cases. Higher scores on BPD and TLX indicate greater musculoskeletal

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discomfort and mental strain. BPD scores were averaged over body regions:

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head/neck; back; hand/wrist; arms; and knees/ankles/feet. Changes in body-

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region-specific discomfort scores were the primary outcomes.

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Measurements and Main results:

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Multivariable analysis was performed using mixed effects linear regression with

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surgeon as a random effect. 16 surgeons participated: 53% fellows, 34%

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residents,13% attendings. 33 robotic and 53 laparoscopic cases were analyzed,

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with median surgical time 231 [204,293] vs 227 [203,272] minutes (p=.31),

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median EBL 100 [50,175] vs 150 [50,200] mL (p=.22), and mean patient BMI

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27±4 vs 26±4 kg/m2 (p=.26), respectively.

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Robotic surgeries were associated with lower neck/shoulder (-0.19 [-0.32, -0.01],

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T=-2.49) and back discomfort scores (-0.35 [-0.58, 0], T=-2.38) than laparoscopic

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surgeries. Knee/ankle/foot and arm discomfort increased with case length (0.18

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[0.02, 0.3], T=2.81) and (0.07 [0.01, 0.14], p=.03), respectively).

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Conclusion:

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Surgeons performing minimally invasive sacrocolpopexy experienced less neck,

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shoulder, and back discomfort when surgery was performed robotically.

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Introduction: Recent surveys across many surgical disciplines suggest that

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performance of laparoscopic surgery may be delivered at an ergonomic cost to

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the surgeon (1, 2, 3). Survey data from general surgeons and gynecologic

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oncologists who regularly performed laparoscopic surgery shows that 86-88% of

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respondents reported physical discomfort that they attributed to minimally

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invasive surgery, especially in the neck and upper extremities (1, 2, 3). Studies

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utilizing postural analysis and upper extremity electromyographic (EMG) data

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during live and simulated laparoscopic surgery suggest that laparoscopic surgery

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induces a more static posture compared with open surgery (4, 5) and induces

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higher EMG potentials in the thumb, forearm flexor and deltoid compared with

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open surgery (6). In addition, other physiologic parameters of stress have been

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reported to be elevated during laparoscopic simulation compared with open

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surgical simulation (7). Most laparoscopic instrumentation has limited degrees of

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freedom with the motion of the operative hand scaled variably down the operative

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shaft of the instrument (8, 9). Incorrectly positioned monitors can contribute to

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eye and neck strain and can also negatively impact laparoscopic performance

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(10).

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The use of robotic assistance in laparoscopic surgery may help overcome

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some of these ergonomic challenges. Initial reports suggest that robotic surgery

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may be more ergonomically favorable and less mentally stressful than traditional

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laparoscopy with similar or greater efficiency (11, 12, 13, 14), but this potential

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ergonomic benefit may be offset by longer operative times and greater costs (15,

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16, 17). Although Lawson et al (11) utilized the Body Part Discomfort scale

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(BPD) (18), most of these studies utilize EMG data or do not utilize widely

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validated measures of ergonomic strain. A recent study of 13 surgeons with

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varying levels of minimally invasive surgical experience demonstrated that dry

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lab tasks were physically and cognitively less challenging when using robotic

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assistance compared with traditional laparoscopic techniques, as illustrated

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lower work load scores on the National Aeronautics and Space Administration

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Task Load Index (NASA-TLX) (19).

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The primary aim of this pilot study was to compare surgeons’ ergonomic

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strain and subjective workload when performing laparoscopic or robot assisted

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laparoscopic sacrocolpopexy. Our secondary aim was to determine whether

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patient body mass index (BMI) and length of surgery are related to ergonomic

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strain and subjective workload when performing sacrocolpopexy via either a

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laparoscopic or robot-assisted laparoscopic method.

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Materials and Methods:

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After obtaining IRB approval (IRB number: 202153), resident, fellow and attending urologic and gynecologic surgeons at Loyola University Medical

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Center, Chicago, IL, were approached for study participation. Participants were

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approached if they were the primary surgeon or the bedside assistant during the

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surgical case. A consent letter was given, and participants completed

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demographics and validated questionnaires assessing musculoskeletal and

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mental strain at the time of sacrocolpopexy from October 2009- January 2011.

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Our study tools were two previously validated instruments that have been applied to a variety of fields. The Body Part Discomfort scale (BPD) was

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originally developed by Corlett and Bishop in 1976 to assess postural discomfort

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throughout the workday associated with use of spot welding machines (18).

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Since its introduction, the BPD has been adapted and utilizes 15-27 body regions

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and usually uses a rating system from either 0-5 or 1-5, with 5 indicating

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intolerable pain or severe discomfort (20, 21) (Figure 1). The Body Part

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Discomfort Frequency (BPDF) is the fraction of all non-zero (no discomfort)

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ratings, and the Body Part Discomfort Severity (BPDS) is the mean severity of all

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non-zero ratings (20). Both the BPDF and the BPDS have been validated against

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physiologic parameters while performing various postural tasks (21, 22). The

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BPD has been shown to be both reliable and sensitive to postural variations (20).

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The National Aeronautics and Space Administration Task Load Index

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(NASA-TLX) which was developed for use in aircraft simulation has been applied

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to studies of human performance in a variety of settings (23). It is a multi-

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dimensional rating scale that provides an overall workload score based on a

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weighted or unweighted average of ratings on six subscales: mental demands,

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physical demands, temporal demands, own performance, effort, and frustration

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(23, 24) (Figure 2). Participants rate the amount of demand for a particular task,

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ranging from “Very Low” to “Very High” on each of the six subscales of the

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NASA-TLX, each scored from 0 to 100. Higher scores on the subscales of the

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TLX indicate greater perceived demand. These subscale scores are typically

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summed to derive a Total NASA TLX score (0-600). Although it was originally

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developed to for use in aircraft simulation, it has been used in studies assessing

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human performance in space applications, automobile operation, portable

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technologies, and robotics (19, 24, 25). Participants completed the BPD prior to each case and completed the

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NASA-TLX and BPD survey following each case. A 5-point scale was used for

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the BPD (1=no discomfort and 5=maximum discomfort) (Figure 1). A total, non-

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weighted NASA-TLX score was calculated by summing the six subscale scores

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(range 0-100) for each subject’s surgical case, with total TLX scores ranging from

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0-600.

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Data regarding surgeon demographics and operative experience was collected. In addition, surgical data for each case was collected, including

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operative time (defined as incision time until final incision closure), estimated

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blood loss (EBL), patient BMI (kg/m2), conversion to an open case, and history of

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prior abdominal and pelvic surgeries.

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Statistical Analysis

All data was collected and stored in a database, de-identified to any

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patient factors. SPSS Version 16.0 (Chicago, IL) was used for database

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management, and R statistical software with the lme4 package (Vienna, Austria)

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was used for analysis.

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BPD scores were averaged over the body regions: head/neck; back;

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hand/wrist; arms; and knees/ankles/feet. Change in body part discomfort for each

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surgeon during a particular surgical case was calculated by: BPD before- BPD

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after. Univariable summaries appear as means and standard deviations for

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normally distributed values and medians and interquartile ranges for non-

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normally distributed data. Linear regression was used to perform a multivariable analysis with

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changes in Body Part Discomfort for the five body regions as the outcome. Since

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several surgeons performed multiple surgeries within the study, random effects

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models were considered for multivariable analysis. Likelihood ratio tests and

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plots of the marginal means were used to evaluate the improvement of the fit

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when going from a traditional linear model to a mixed effects model. This was

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performed on intercept only models. If there was no evidence of significant

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variability among the surgeon marginal means, a traditional model was used.

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Model building continued by successively adding the variables of type of surgery

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(robotic or laparoscopic), length of surgery, patient BMI, NASA TLX total work

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load score, and year of surgeon training. If no improvement of model fit was

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indicated by a variable, the variable was left out of the model. Patient BMI was

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retained in the final models to determine if it was associated with changes in

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body part discomfort. Likelihood ratio test p values of < 0.10 for random effects

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and < .05 for fixed effects were considered to be a significant result for inclusion

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in the model. This process was repeated for each of the change in Body Part

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Discomfort scores for the five body regions.

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Traditional linear models are summarized by coefficients, 95% confidence

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intervals, and p-values with significance for these models determined by p-value

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≤ 0.05. Mixed effects linear models are summarized by coefficients, 95%

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bootstrapped confidence intervals, and calculated t-statistics. Because the data

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are small and unbalanced, p-values are not reported; significance is inferred from

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an absolute t-statistic greater than or equal to 2.0.

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Results:

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Sixteen surgeons participated: 53% fellows, 34% residents and 13%

attending surgeons. Mean age for surgeons was 33 years (range 27-54), the

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majority (12/16) were female, and all reported “good” or “excellent” health. Prior

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to participation in this study, surgeons had completed a mean of 49 robotic

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(range 0-200), 35 laparoscopic (range 1-125), and 149 open (range 0-1000)

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surgical cases.

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Eighty-six sacrocolpopexy cases were analyzed, including 33 robotic and 53 laparoscopic with median surgical time 231 [204,293] vs 227 [203,272]

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minutes (p=.31), median EBL 100 [50,175] vs 150 [50,200] mL (p=.22), and

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mean patient BMI 27±4 vs 26±4 kg/m2 (p=.26), respectively. There was no

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difference in the percentage of concomitant hysterectomies performed between

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the robotic and laparoscopic surgery groups, respectively (73% vs 64%, p= .38).

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The majority (73%) of the robotic cases were performed with the daVinci Si®

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Surgical System (Intuitive Surgical, Sunnyvale, CA), and the remainder with the

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daVinci S® Surgical System (Intuitive Surgical, Sunnyvale, CA).

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There was no significant difference in the six NASA TLX subcategory (all

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p>.05) or total NASA TLX workload scores between the robotic and laparoscopic

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surgery groups (335 [260,375] vs 325 [283,263] p=0.66). In addition, neither

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preoperative nor postoperative median BPD scores differed significantly between

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robotic and laparoscopic surgery groups (p>.05). After dichotomizing the BPD

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scores into “no pain” (BPD=1) and “pain” (BPD>1), the frequency of pain

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increased postoperatively in all body part areas for both the robotic and

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laparoscopic surgery groups, except for the arms (Figure 3).

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The final models for change in Body Part Discomfort each of the 5 areas

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of body included the following variables: neck/shoulder (type of surgery), back

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(type of surgery, NASA TLX score), hand/wrist (length of case, NASA TLX

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score), knee/ankle/foot (type of surgery, length of case), arms (length of case).

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Surgical modality was a significant factor in only the models for both change in

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neck/shoulder and back discomfort. Robotic surgeries were associated with

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lower neck/shoulder (-0.19 [-0.32, -0.01], T=-2.49) and back discomfort scores (-

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0.35 [-0.58, 0], T=-2.38) than laparoscopic surgeries. Knee/ankle/foot and arm

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discomfort increased with case length (0.18 [0.02, 0.3], T=2.81) and (0.07 [0.01,

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0.14], p=.03), respectively). There was a trend toward higher total TLX scores

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being associated with greater back discomfort scores (0.17 [0.05, 0.37], T=1.96).

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In addition, there was a trend toward greater discomfort in knee/ankle/foot

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discomfort in laparoscopic cases compared with robotic cases (-.20 [-0.37, 0.04],

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T=-1.97), but T was not >2.0 and, therefore, failed to achieve statistical

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significance. Patient BMI, when evaluated in these models, showed no

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relationship with changes in discomfort (in each model, the absolute T-score

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associated with BMI was less than 1.0).

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Discussion:

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This pilot study demonstrates an ergonomic benefit in the neck/shoulder and back regions when using robotic surgery to perform a minimally invasive

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sacrocolpopexy. Longer cases also resulted in higher Body Part Discomfort

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scores in the knees/ankles/feet and the arms in both minimally invasive surgical

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groups. Interestingly, the NASA TLX score did not seem to be a significant

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predictive factor in ergonomic change.

This study has several strengths. We utilized widely validated ergonomic

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and task strain indices. Unlike many studies evaluating surgical ergonomic

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parameters, our ergonomic and task strain measurements were taken during live

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surgery and not in a surgical dry lab. The majority of the sixteen surgeons in our

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study were fellow and resident trainees. Consequently, our findings should be

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generalizable to surgeons in training performing minimally invasive

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sacrocolpopexy. Finally, we compared pre and post measures of Body Part

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Discomfort for each participant, so each participant served as their own control.

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Since our work was a pilot study, no power calculation was performed;

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consequently, we cannot discern causality from our methods. This study was

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relatively small and only included 16 surgeons at a single academic medical

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center. Although there were no baseline differences between Body Part

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Discomfort scores between the surgeons in the robotic and laparoscopic groups

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and we had surgeons report on their perceived overall health status, we did not

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capture data concerning surgeons’ pre-existing musculoskeletal or pain

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disorders. Selection bias could have been present, as surgeons with pre-existing

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pain conditions could have chosen one surgical approach over the other. Our

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statistical analyses were limited by unbalanced data, limiting our ability to

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estimate the variance surrounding our measures. Consequently, our results may

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have limited generalizability. Since the number of surgeon participants was small,

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we could not do subgroup analysis between different levels of surgeon training.

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Recent survey data from minimally invasive surgeons suggests that the highest

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degrees of ergonomic strain are reported by surgeons in their earliest years of

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practice (2, 3). In addition, we did not evaluate differences in ergonomic strain as

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a function of gender or glove size. These have also been reported to be

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significant factors associated with laparoscopic strain (2). Finally, we did not

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report any concurrent physiologic parameters of ergonomic strain or physiologic

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stress, such as EMG or skin conductance testing. These measures have been

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traditionally used in laparoscopic and robotic dry lab ergonomic testing scenarios

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(6, 7, 13, 14).

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Conclusion:

Our work is one of the first studies that compares ergonomic parameters

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between robotic and laparoscopic surgery for sacrocolpopexy. Since minimally

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invasive sacrocolpopexies are commonly performed by reconstructive pelvic

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surgeons, we offer some insight to the ergonomic experience of both trainee and

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attending surgeons performing these surgeries. Given the reported laparoscopic

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strain and the purported, though not widely studied, benefits of robotic

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assistance, this is an area that warrants further research. Future work would

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include a larger, possibly multicenter trial, with the inclusion of physiologic

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parameters.

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Figure Legends:

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Figure 1. Body Part Discomfort Scale

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Reprinted with written permission from EN Corlett

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Originally published in: Corlett EN, Bishop RP. A technique for assessing

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postural discomfort. Ergonomics 1976;19(2):175-182.

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Figure 2. NASA Task Load Index

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Reprinted with permission

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http://humansystems.arc.nasa.gov/groups/TLX/downloads/TLXScale.pdf

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Originally published in: Hart SG, Staveland LE. Development of a multi-

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dimensional workload rating scale: Results of empirical and theoretical research.

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In: Hancock PA, Meshkati N, eds. Human Mental Workload. Amsterdam, The

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Netherlands; North Holland Press 1988.

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Figure 3. Frequencies in reported BPD pain by body region, before and after

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surgery

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http://www.AAGL.org/jmig-22-2-JMIG-D-14-00429

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http://www.AAGL.org/jmig-22-2-JMIG-D-14-00429

Comparison of postural ergonomics between laparoscopic and robotic sacrocolpopexy: a pilot study.

To compare resident, fellow, and attending urologic and gynecologic surgeons' musculoskeletal and mental strain during laparoscopic and robotic sacroc...
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