To: Dr.

Merryweather
From: John Lackey, Jon Browne
Date: February 24, 2017
Subject: Semester Project Proposal

Background:
Laparoscopic surgery is a non-invasive technique physicians around the globe use in order to decrease
scar size and probability of hernia post-procedure. Due to these benefits, the popularity of the
procedure increases year after year. Physicians may use this method for any surgery within the
abdomen or pelvic region and use a laparoscope as their viewing mechanism for the different cases.
During the procedure, the laparoscopic lens becomes soiled or fogged. This soiling blinds the operating
team and halts the procedure. This soiling occurs usually six times per hour [1] costing the surgeons,
hospitals, and patients, time and money. The purpose of this study is to show additional data that a
medical device currently being developed will be save the hospital thousands of dollars a year.

Hypothesis:
We hypothesize that a device that obviates the need to clean laparoscope lens would save on average
at least $100 per procedure. As the device is expected to cost the hospital $20, we will test this
hypothesis by determining if the cost associated with needing to clean lenses is greater than $120.

Experimental Design:
To test our hypothesis, we will use data from two sources to determine the time and money cost lost
due to cleaning lenses. We will first collect data by observing laparoscopic procedures. The variables
recorded from this observational study will be: the physician performing operation, procedure type,
number of times lens was cleaned, and total time taken to clean lenses. We plan on observing at least
10 procedures, but will observe as many as possible to get the largest possible sample size. There is
various literature on the frequency of fogging events. One conservative estimate is an average of 1.4 (
= 1.0) fogging events per hour [2], while another source reports an average of 6 times per hour [1]. The
University of Utah estimates their operating room costs at $60/min. For an average surgery time of 90
min and the conservative estimate of 1.4 fogging events per hour, this translates to an average cost of
3.15 min and $189. For the given effect size of $69, we would need to collect 11 samples to have a
power level of 0.8. We will then use data provided by the University of Utah Hospital to determine the
actual cost per minute of laparoscopic procedures, which will be used to calculate to cost associated
with lost time to cleaning lenses. A one-tailed 1-sample t-test with an alpha of 0.05 will be used to
determine if the average cost associated with cleaning lenses is greater than $120. If enough samples
are able to be collected, we will group the samples by the other factors such as individual physicians or
procedures, and perform an ANOVA test to see if the groups differ.

Data Collection:
An observational study will be done to determine the number of times the laparoscope lens must be
cleaned in each procedure and the total time it takes to perform those cleanings. The expected
procedure for this test method is as follows:
 1. A member of the team will be present in the OR observing laparoscopic procedures and note
the physician performing the operation and the type of surgery
2. Each time the operating team withdraws the laparoscope to clean the lens, the team member
will record the event. The total number of cleaning events will be recorded for each procedure
3. The team member will start a timer the instant the scope is removed, and stop the timer once
the operation is resumed. This time will be recorded for each individual cleaning, and the total
time will be recorded for each surgical procedure.

Description of Dataset:
The University of Utah Hospital will provide a dataset on laparoscopic procedures. As we do not yet
have the dataset, we do not know exactly what variables are included nor the size of the dataset. We
expect it to include the following variables:
Length of procedures
Cost of procedures
Cost per minute of procedure
Cost of different physicians

Literature Review
While there are numerous articles in the literature describing various methods at reducing laparoscope
fogging, these articles for the most part simply describe methods and do not report on the cost-
effectiveness of the methods themselves [2, 3]. For example, Runia et al. describe a simple method of
cleaning a laparoscope lens but provide no data or statistical analysis to validate the effectiveness of
their method [4]. This highlights the need for observational studies that report the actual frequency of
scope withdrawals and operating time lost due to the operating team becoming blind.

References

[1] McKenna D, Burchett M, Choi J, Mattar S, Selzer, D; Indiana University Medical Center; A
Novel Device Maintaining Clear Optics During Surgery; SAGES 2013, Session: Poster
Presentation, Program number: ETP033, April 17-20, Baltimore MD.

[2] A. Drysch et al., Comparative analysis of techniques to prevent laparoscopic fogging, Minim
Invasive Ther Allied Technol, vol. 25, pp. 319-322, 2016.

[3] N. Lawrentschuk et al., Laparoscopic Lens Fogging: A Review of Etiology and Methods to
Maintain a Clear Visual Field, J Endourol, vol. 24, pp. 905-913, 2010.

[4] Runia, A.J., Zengerink, J.F. & Mannaerts, G.H.H. Surg Endosc (2009) 23: 2849.
doi:10.1007/s00464-009-0648-3