Prospective Randomized Evaluation of FOOT Gel Pads for Operating Room Staff COMFORT During Laparoscopic Renal Surgery

Prospective Randomized Evaluation of FOOT Gel Pads for Operating Room Staff COMFORT During Laparoscopic Renal Surgery

Laparoscopy and Robotics Prospective Randomized Evaluation of FOOT Gel Pads for Operating Room Staff COMFORT During Laparoscopic Renal Surgery Georgio...

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Laparoscopy and Robotics Prospective Randomized Evaluation of FOOT Gel Pads for Operating Room Staff COMFORT During Laparoscopic Renal Surgery Georgios Haramis, Juan Carlos Rosales, Jorge Moreno Palacios, Zhamshid Okhunov, Adam C. Mues, Diana Lee, Ketan Badani, Mantu Gupta, and Jaime Landman OBJECTIVES METHODS

RESULTS

CONCLUSIONS

We evaluated the comfort level of our laparoscopy team during and after laparoscopic renal surgery, with or without the use of gel footpads. Between September 2008 and April 2009 we prospectively randomized 100 consecutive laparoscopic renal procedures to examine whether the use of a foot gel pad altered the surgical team’s comfort level. A questionnaire was used to measure the discomfort in 18 different subjects before and during surgery, and one day postoperatively. The procedures performed with or without the foot gel pads were compared. One hundred laparoscopic procedures were randomized to being performed with and without gel pads. In 50 procedures, the foot gel pad was used. The mean age of the subjects was 36 years (range 25-52). The mean surgical experience was 7 years. The characteristics of the participants in procedures with and without the gel pad were similar. In the immediate postoperative period, there were significantly more breaks taken (P ⫽ .001), number of stretches (P ⫽ .001), foot pain (P ⫽ .003), knee pain (P ⫽ .001), back discomfort (P ⫽ .001), overall discomfort (P ⫽ .001), and diminished level of energy (P ⫽ .049) in the group not using the gel pad. Of the 24-hour postoperative time point, evaluation significantly favored the gel pads regarding foot pain (P ⫽ .004), overall amount of discomfort (P ⫽ .001), and energy level of the participants (P ⫽ .044). The use of foot gel pads improves surgeon comfort and ergonomics during laparoscopy. The pads have been incorporated into our routine operating room set-up and may improve surgical performance by diminishing fatigue and discomfort. UROLOGY 76: 1405–1408, 2010. © 2010 Elsevier Inc.

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omparison of general ergonomics between open and laparoscopic surgery have demonstrated increased surgeon discomfort during laparoscopic procedures.1-4 Even among experienced laparoscopic surgeons, significant musculoskeletal complaints related to the neck and arms appear to be common.5-7 It has been demonstrated that surgeons and scrub nurses exhibited frequent static body postures that were “distinctly harmful” and contributed to physical fatigue during surgery.8,9 Several minimally invasive surgery components including long-shaft instruments, access ports, and endoscopic image display systems have been identified as contributing to ergonomically unfavorable postures that are assumed and maintained by laparoscopic surgeons.3,6,10 As such, it is clear that maintaining correct posture is very important in minimizing physical risks associated The authors want to declare that they have no financial relationship with the manufacturer of the foot pads. From the Columbia University School of Medicine, Department of Urology, New York, NY, USA Reprint requests: Jaime Landman, 161 Fort Washington Avenue, Room 1154, New York, NY 10032. E-mail: [email protected]

© 2010 Elsevier Inc. All Rights Reserved

with the performance of complex tasks.11 Using a detailed questionnaire, we evaluated a foot gel pad to determine whether it offered any advantage to surgeons and operating room staff in the setting of laparoscopic renal surgery.

MATERIAL AND METHODS Permission for evaluation was obtained from our institutional review board. Between September 2008 and April 2009, we performed a pilot study and evaluated 100 procedures incorporating 18 different subjects using a foot gel pad to assess comfort and fatigue level during and after surgery. The study group included 5 attending physicians with more than 10 years of experience in minimally invasive surgery, 6 urology residents, 2 minimally invasive urology fellows, and 5 scrub nurses from our surgical team. All subjects were interviewed through a questionnaire minutes before the start of each procedure. All participants reported to be in good general health. A computergenerated randomization sheet was used to prospectively establish whether the Gelmat was to be used on a particular procedure. All members of the surgical team were tested under the same condition for each case. All subjects received an equal number of evaluations with or without the use of gel pads. Gel 0090-4295/10/$36.00 doi:10.1016/j.urology.2010.01.018

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Table 1. Operating room team characteristics Variables

Mean

Range

SD

Age (yrs) Surgical experience (yrs) Last day exercise d/wk exercise

36.29 7.16 6.46 1.01

25-52 1-19 1-75 1-5

4.93 3.57 10.94 1.13

pads were kindly donated (Gelpro, Austin, TX) and we used the commercially available basket weave design 20 ⫻ 60-inch mats (average price $USD200). The mats were introduced into the operating room with the permission of the operating room director and were cleaned and processed by standard technique between surgical cases. The questionnaire administered included subjects’ age, years performing operating room activities, last day vigorous exercise was performed, and day/week of exercise. A scale of discomfort/ pain was used, with values ranging from 1 (minimal discomfort or no pain) to 10 (severe discomfort or pain). The questionnaires were applied before, immediately after, and 24 hours after surgery. We also recorded the type and length of the procedure, the time spent in standing and sitting positions, and the duration of the whole process. An independent observer documented the number of intraoperative postural changes, the number of stretching events, and the number of breaks taken for discomfort during the procedure. The subjects were also asked to report whether they felt they changed their posture more or less frequently than usual and whether they were more or less fatigued. Finally, we asked them to subjectively report the number of errors made as a result of fatigue or discomfort during the procedure. A comparison was made between subjects who performed procedures with the gel pad and those who did not, in an effort to identify whether its use improved the surgical team’s performance and surgical ergonomics. Continuous and categorical variables were analyzed with Student’s t-test and the chi-square test, respectively. Two cross tabulations were made to compare both groups regarding perception of fatigue and number of errors made after each procedure. The statistical package used was SPSS 17 (SPSS, Inc., Chicago, IL). As a pilot study, no formal power evaluation was performed and we randomly assessed 100 procedures.

RESULTS A total of 100 procedures were evaluated. The characteristics of our sample are summarized in Table 1. The mean age was 36.2 years (range 25-52). Mean surgical experience was 7.1 years and the mean last day of exercise was 6.4 days. All subjects evaluated in this study did exercise at least once per week. The surgical procedures included in our study were laparoscopic partial nephrectomies (LPN; n ⫽ 31), laparoscopic cryoablations (LCA; n ⫽ 36), laparoscopic radical nephrectomies (LRN; n ⫽ 28), and robotic renal procedures (n ⫽ 5). Fifty of the above mentioned procedures were randomized to use of the gel-mat pads were applied to improve the participants’ comfort (Fig. 1). During robotic procedures, only bedside assistants were evaluated as the surgeon was sitting at the console. 1406

Figure 1. Members of the surgical team standing on the gel mat. Table 2. Preoperative evaluation of participants assigned in gel-mat and non-gel mat groups Variable No subject Age (mean) Surgical experience (years) d/wk exercise Feet Ankle Knees Hips Back Neck Overall discomfort

Gel-mat Group 50 36.3 7 1.02 1.68 1.22 1.44 1.36 1.66 1.56 1.56

Nongel-mat Group 50 31.2 7.2 1 1.42 1.26 1.44 1.20 1.94 1.52 1.96

P Value NA .06 .255 .153 .062 .458 .905 .085 .111 .935 .071

There were no differences in participants’ preoperative characteristics between the 2 groups (Table 2). Regarding the immediate postoperative evaluation, the results between the 2 groups were statistically significant for an advantage with gel pad use in the number of times stretched (P ⬍ .001), number of breaks taken (P ⬍ .001), foot discomfort/pain (P ⫽ .003), knee discomfort/pain (P ⬍ .001), and back discomfort/pain (P ⬍ .001), respectively. The overall amount of discomfort (P ⬍ .001) and level of energy (P ⫽ .049) are depicted in Table 3. We also observed differences 24 hours postoperatively in foot discomfort/pain (P ⫽ .004), overall discomfort (P ⬍ .001), and level of energy (P ⫽ .049) (Table 4). Cross tabulation regarding perception of fatigue after each procedure between gel-mat and nongel-mat groups was made. We found less fatigue in the gel-mat group (n ⫽ 41, 82%) compared with that in the nongel-mat group (n ⫽ 29, 58%) (P ⬍ .001). Finally, a cross tabulation was also performed regarding perceived surgical errors made during each procedure between gel-mat and nongel-mat groups. In accordance with the previous results, there were more errors in the nongel-mat group (n ⫽ 6, 12%) (P ⫽ .041). UROLOGY 76 (6), 2010

Table 3. Postoperative evaluation of gel-mat and nongelmat groups Variables

Gel-mat Group

Nongel-mat Group

P Value

OR time (min) Standing time (min) Sitting time (min) No postures changed No stretched No breaks taken Feet Ankle Knees Hips Back Shoulders Neck Overall discomfort Overall level of energy

106.68 76.5 30.18 1.1 1.28 1 1 1.32 1.28 1.2 1 1.6 1.56 1 8.7

110.2 95 15.2 1.42 2.8 2.8 2.26 1.62 2 1.3 3.08 1.6 1.94 2.4 8

.926 .607 .001 .873 .001 .001 .003 .281 .001 .108 .001 .731 .069 .001 .049

Table 4. Twenty-four hours postoperative evaluation of gel-mat and nongel-mat groups Variable Feet Ankle Knees Hips Back Shoulders Neck Overall discomfort Overall level of energy

Gel-mat Group

Nongel-mat Group

P Value

1.24 1.24 1.26 1.24 1.52 1.40 1.3 1.24 9.3

1.64 1.28 1.34 1.26 1.66 1.42 1.42 1.8 8.88

.004 .427 .336 .642 .394 .917 .200 .001 .044

COMMENT Laparoscopic surgery in urology is more physically challenging and demanding than traditional open surgery. Ergonomics is a relatively new field of science that has recently gained popularity.1,2 The science of ergonomics analyzes the surgical challenges and formulates guidelines for creating a work environment that is safe and comfortable for its operators while effectiveness and efficiency of the process are maintained.12 A growing amount of literature raised concerns about the ergonomic problems of video endoscopic surgery teams.3,5-7 Gofrit and colleagues reported neuromuscular and arthritic symptoms in 30% of urologists regularly performing laparoscopic procedures.13 In addition, it is also known that maintenance of correct body posture is a very important ergonomic factor credited not only with minimizing physical discomfort but also with improvement of task performance.14-16 In other words, maximizing surgeons’ comfort level results in better technical performance and reduces the margin of error. Most work done to date has been focused on the improvement of working conditions in the operating room and thus the improvement in productivity. Our main goal in this study was to see whether our dedicated UROLOGY 76 (6), 2010

surgical team could achieve an improved comfort level at the operating room by the simple application of a gel-mat pad. We evaluated our team, which consisted of 18 people with different roles, including 5 attending surgeons with more than 10 years of experience in minimally invasive surgery. The rest of the group included 6 urology residents from our department, 2 fellows from the minimally invasive urology program, and 5 scrub technicians and circulating nurses working regularly as part of our team in the operating room. All participants reported to be in good health and physical condition. Each subject was given a tutorial regarding which condition was regarded as discomfort/pain before each minimally invasive procedure. Most of the procedures were lengthy (⬎2 hours) and included multiple types of minimally invasive surgery, including complex laparoscopic ablative and reconstructive procedures, as well as robotic and endoscopic procedures. During the 5 robotic procedures, only bedside assistants were evaluated (represent more traditional laparoscopic challenges). Subjectively, our team felt strongly that the gel pad application during laparoscopic renal surgery was very advantageous. Most participants perceived a better level of energy and less discomfort in immediate postoperative time (P ⬍ .001) and 24 hours after the procedure (P ⫽ .046). Similar ergonomic studies have been performed with metrics including electromyography and other sophisticated technologies. However, these metrics are more expensive, less practical, and have never been validated and shown to be superior to subjective assessments in this capacity.11 We believe that the most important parameter is the surgical teams’ subjective evaluation of their own condition. However, although intuitively a comfortable surface would seem to optimize surgeon comfort, the “placebo effect” of the Gelmat must be considered because we did not have a control to eliminate this possibility. The posture of the surgeon and the operating team is affected by 4 major factors: the height of the operating table, the design of the instruments, the position of the monitor, and the foot pedals. Height is not always optimal for the remaining members of the team and can lead to ergonomically poor conditions. The working surface height, relative to a subject performing manual work, determines the upper extremity effort and the potential for musculoskeletal injury.5,17 Several different ergonomic body support devices have been used by laparoscopic surgeons in an effort to reduce muscle activity and diminish, over the long term, physical complaints and discomfort.18 However, these are expensive and seem less practical equipment.19 Laparoscopic surgery requires a high proportion of static neck and back postures.20 We introduced in our everyday practice a simple, cost-effective, and easily maintained device that improved the tolerability of our procedures. The use of a gel-mat pad seems to offer a 1407

better body posture, while diminishing at the same time the discomfort experienced in the back, knees, and feet. In accordance with the aforementioned findings, the overall physical discomfort in the procedures where gel pads were not used was considerably higher (P ⬍ .001). It became evident from our study that much of the postural and musculoskeletal disadvantages for the surgeon and the operating room staff related to laparoscopic surgery can be minimized using a gel-mat pad. As such, we have incorporated the gel-mat into all our laparoscopic procedures as a standard part of the operating room set-up. There were no adverse events or challenges associated with the application of the gel-mat pads.

CONCLUSIONS The application of a foot gel pad during laparoscopic renal surgery provides a simple and effective way to reduce surgical staff discomfort. References 1. Hemal AK, Srinivas M, Charles AR. Ergonomic problems associated with laparoscopy. J Endourol. 2001;15:499-503. 2. Kaya OI, Moran M, Ozkardes AB, et al. Ergonomic problems encountered by the surgical team during video endoscopic surgery. Surg Laparosc Endosc Percutan Tech. 2008;18:40-44. 3. Berguer R, Chen J, Smith WD. A comparison of the physical effort required for laparoscopic and open surgical techniques. Arch Surg. 2003;138:967-970. 4. Johnston WK 3rd, Hollenbeck BK, Wolf JS Jr. Comparison of neuromuscular injuries to the surgeon during hand-assisted and standard laparoscopic urologic surgery. J Endourol. 2005;19:377381. 5. van Veelen MA, Kazemier G, Koopman J, et al. Assessment of the ergonomically optimal operating surface height for laparoscopic surgery. J Laparoendosc Adv Surg Tech A. 2002;12:47-52.

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6. Berguer R, Forkey DL, Smith WD. Ergonomic problems associated with laparoscopic surgery. Surg Endosc. 1999;13:466-468. 7. Wauben LS, van Veelen MA, Gossot D, et al. Application of ergonomic guidelines during minimally invasive surgery: a questionnaire survey of 284 surgeons. Surg Endosc. 2006;20:1268-1274. 8. Kant IJ, de Jong LC, van Rijssen-Moll M, et al. A survey of static and dynamic work postures of operating room staff. Int Arch Occup Environ Health. 1992;63:423-428. 9. Vereczkei A, Feussner H, Negele T, et al. Ergonomic assessment of the static stress confronted by surgeons during laparoscopic cholecystectomy. Surg Endosc. 2004;18:1118-1122. 10. Carswell CM, Clarke D, Seales WB. Assessing mental workload during laparoscopic surgery. Surg Innov. 2005;12:80-90. 11. Lee G, Lee T, Dexter D, et al. Ergonomic risk associated with assisting in minimally invasive surgery. Surg Endosc. 2009;23:182188. 12. van Det MJ, Meijerink WJ, Hoff C, et al. Optimal ergonomics for laparoscopic surgery in minimally invasive surgery suites: a review and guidelines. Surg Endosc. 2009;23(6):1279-1285. 13. Gofrit ON, Mikahail AA, Zorn KC, et al. Surgeons’ perceptions and injuries during and after urologic laparoscopic surgery. Urology. 2008;71(3):404-407. 14. Lee G, Park AE. Development of a more robust tool for postural stability analysis of laparoscopic surgeons. Ann Surg Mar. 2006; 243(3):329-333. 15. Liao MH, Drury CG. Posture, discomfort and performance in a VDT task. Ergonomics. 2000;43:345-359. 16. Bhatnager V, Drury CG, Schiro SG. Posture, postural discomfort and performance. Hum Factors. 1985;27:189-199. 17. Manasnayakorn S, Cuschieri A, Hanna GB. Ergonomic assessment of optimum operating table height for hand-assisted laparoscopic surgery. Surg Endosc. 2009;4:783-789. 18. Galleano R, Carter F, Brown S, Frank T, Cuschieri A. Can armrests improve comfort and task performance in laparoscopic surgery? Surg Endosc. 2008;22(4):1087-1092. 19. Albayrak A, van Veelen MA, Prins JF, et al. A newly designed ergonomic body support for surgeons. Surg Endosc. 2007;21:18351840. 20. Nguyen NT, Ho HS, Smith WD, et al. An ergonomic evaluation of surgeons’ axial skeletal and upper extremity movements during laparoscopic and open surgery. Am J Surg. 2001;182(6):720-724.

UROLOGY 76 (6), 2010