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Use of a low fidelity contained manual tissue extraction simulation to improve gynecology resident competence and confidence

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Use of a low fidelity contained manual tissue extraction simulation to improve gynecology resident competence and confidence

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Content Saad, 1

Use of a Low Fidelity Contained Manual Tissue Extraction Simulation to Improve Gynecology
Resident Competence and Confidence

Christina Adel Saad, MD, MBA
Clinical, Biomedical, and Translational Investigations
Master of Science
University of Southern California, Keck School of Medicine
August 6, 2016

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Table of Contents
Background Page 3
Materials and Methods Page 4
Results Page 5
Discussion Page 6
References Page 8
Figure Legends Page 10

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Background
Uterine fibroids are extremely common among women, some studies indicate that their prevalence is up
to 70% in white women and 80% in black women by 50 years of age.
1
There are medical and surgical
treatment options for symptomatic uterine fibroids, surgical options including myomectomy (surgical
resection of the fibroids) or hysterectomy (removal of the uterus). Hysterectomy is one of the most
commonly performed surgical procedures in the United States; a study conducted in 2000-2004 revealed
that approximately 600,000 hysterectomies were performed annually, and that symptomatic uterine
fibroids were the most common indication for this procedure (40.7%).
2
Minimally invasive approaches
have several benefits when compared to traditional open approaches to hysterectomy. Laparoscopic
hysterectomies when compared to abdominal hysterectomies have faster return to normal activity, shorter
duration of hospital stay, smaller drops in hemoglobin, lower intraoperative blood low, and fewer wound
or abdominal infections.
3
In order to extract larger fibroid or uterine specimens laparoscopically, a tool
called the power morcellator was developed to mince the tissue and allow for its removal through the
small laparoscopic incisions.
Recent controversy surrounding the use of power morcellators triggered an FDA black-box warning that
was released in November 2014 which limited the indications for the use of this device.
4
This notice was
mainly based on the risk of disseminating cancer in the rare instance that the tissue contains an
unrecognized malignancy such as leiomyosarcoma – a risk which was considered miniscule at about 1 in
10,000 due to the rarity of the tumor.
5
The FDA quoted the risk of an underlying malignancy to be much
higher at 1 in 498 for leiomyosarcoma and 1 in 352 for uterine sarcomas,
6
but these numbers have been
criticized by experts as being inaccurate and too high.
7
Additionally, a decision-tree analysis revealed that
the risks of abdominal hysterectomies, including procedure-related deaths, were greater than the risks of
laparoscopic hysterectomies, including the risks of death due to morcellating an underlying malignancy.
8

Since the FDA’s black-box warning, multiple hospitals have banned power morcellators altogether
9
and
several insurance companies have refused to compensate physicians for procedures using this device.
10
In
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order to continue to provide minimally invasive options for women, gynecologists have had to revert to
alternate tissue extraction techniques for large specimens, such as contained manual morcellation also
known as contained manual tissue extraction. This technique uses a traditional scalpel, as opposed to a
power morcellator, to mince the tissue into smaller fragments to allow for removal of the specimen
through the small laparoscopic incisions. In order to avoid the theoretical possibility of dissemination of
an undiagnosed underlying malignancy, this technique is performed in a “contained” fashion where the
specimen is placed within a retrieval bag so that all fragments of the tissue remain within the bag and
completely separated from the abdominal cavity. With the adoption of this technique, we found that
contained manual tissue extraction of large specimens can be difficult and time consuming, and that there
was a learning curve associated with acquiring this skill. We also found that certain techniques
11
allowed
for easier extraction of the specimens, and that few retrieval bags were FDA approved for this
indication.
12
Once we felt that we had perfected our technique, we sought to develop a simulation to
allow physicians to practice contained manual tissue extraction outside of the operating room setting.
Given the rapidity in which the standard of care for this procedure had changed, we found that there were
no scholarly reports on the effectiveness of a simulation for this skill. Our objective was to improve
resident competence and confidence while performing contained manual tissue extraction through a low
fidelity simulation. We sought to create a simulation that was low cost and easy to reproduce in any low
resource setting.
Materials and Methods
This is a prospective cohort study which was deemed IRB exempt (HS-16-00225) at our institution. We
created a low fidelity simulator out of a cardboard box, foam, and liquid latex to simulate an abdomen
with an umbilical incision. (Figure 1) We then filmed an instructional video depicting how to build the
model as well as techniques for contained manual tissue extraction. We ran the simulation on four
different days with each of the four classes of our gynecology residents. Each simulation day started with
our gynecology residents answering a questionnaire assessing their baseline exposure to different tissue
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extraction techniques as well as their level of confidence with contained tissue extraction measured on a
5-point Likert scale. Following the baseline survey, each resident extracted a standardized beef tongue
specimen (355 grams) from our simulator, and the extraction time was recorded. Residents then viewed
the instructional video, and we discussed techniques for more efficient contained manual tissue
extraction. After the video, each resident once again extracted another standardized beef tongue specimen,
and the times were again recorded. Following the simulation, all residents answered another survey
question regarding their level of confidence measured on a 5-point Likert scale. Pre-intervention and post-
intervention extraction times and levels of confidence were then compared using a paired t-test.
Results
28 residents participated, and all levels of residency training were represented. There were six 4
th
year,
six 3
rd
year, eight 2
nd
year, and eight 1
st
year residents. When assessing the tissue extraction time data, we
excluded the 4th year class because during their extractions there was a structural defect in the model,
which was repaired for the remaining classes. Among the 1st, 2nd, and 3rd year residents (Post Graduate
Year [PGY] – 1, 2, 3), the mean tissue extraction time improved by 4 minutes and 1 second (95% CI 2
min 36 sec to 5 min 25 sec) from 8 minutes and 56 seconds before the intervention to 4 minutes and 55
seconds after the intervention (p=0.0001), essentially decreasing the tissue extraction time by 45%.
(Figure 2) Analyses stratified by year of training revealed that residents in all classes experienced
statistically significant improvement in mean tissue extraction time. (Figure 3) Moreover, in the full set
of residents, mean level of confidence with contained manual tissue extraction of a large specimen
increased by 2.19 points (95% CI 1.808 to 2.571) from 1.897 to 4.086 (p=0.0001) on a 5-point Likert
scale after the intervention. (Figure 4) These observed increases in level of confidence after the
intervention were statistically significant even within strata defined by year of training (PGY-1, PGY-2,
PGY-3, PGY-4). (Figure 5)

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Discussion
This low fidelity simulation statistically significantly improved tissue extraction time by 45%, with an
improvement in extraction times noted among gynecology residents at all stages of training. Their level of
confidence in regard to contained manual tissue extraction of a large specimen improved in a statistically
significant fashion as well.
We created this low fidelity simulation in order to help our residents overcome the learning curve
associated with contained manual tissue extraction. Given the abrupt changes within the last two years in
the standard of care for this extremely common procedure, we felt that resident education was not
adapting fast enough to allow graduating residents to competently adopt this newly required skill set. The
same sentiment can be applied to the practice of gynecologists as a whole. One study showed that since
the release of the FDA’s first safety communication, laparoscopic hysterectomies decreased by 4.1% and
both abdominal and vaginal hysterectomies increased. The same study also found that major surgical,
nontransfusion complications as well as 30-day hospital readmissions increased during this time
interval.
13
Thus it appears that some gynecologists have reverted to open procedures rather than risk
proceeding with a laparoscopic approach without the use of a power morcellator, and that this adaptation
is resulting in higher surgical complication rates. Additionally, residents are not being exposed to the
skill sets required to safely proceed with a minimally invasive approach. Residents’ not being
appropriately trained in these techniques has the potential to compound the risks of open procedures in the
future. We hope that this low fidelity simulation can be adopted by other residency training programs as
well as practicing gynecologists to allow larger numbers of gynecologists to offer minimally invasive
approaches to their patients.
Longer term impact of this simulation training warrants evaluation. We hope to learn whether
improvement in confidence initially reported by residents in our cohort will result in their offering
minimally invasive surgical options to their patients during the remainder of their residency and in their
future careers, without tissue extraction being a barrier. Additionally, we would like to see if the 45%
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decrease in tissue extraction time for the smaller specimens used in this intervention will translate to a
decrease in operating room time when our residents are performing tissue extraction of larger specimens.
We intend to investigate these questions in future studies.

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References
1
Day Baird D, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine
leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol 2003;188:100–7.
2
Whiteman MK, Hillis SD, Jamieson DJ, Morrow B, Podgornik MN, Brett KM, et al. Inpatient
hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol 2008;198:34.e1–34.e7.

3
Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, et al. Surgical approach to
hysterectomy for benign gynaecological disease. Cochrane Database of Systematic Reviews 2009, Issue
3. Art. No.: CD003677. DOI: 10.1002/ 14651858.CD003677.pub4.
4
Food and Drug Administration. Updated laparoscopic uterine power morcellation in hysterectomy and
myomectomy: FDA safety communication. November 24, 2014
(http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm).
5
Hall T, Lee SI, Boruta DM, Goodman A. Medical device safety and surgical dissemination of
unrecognized uterine malignancy: morcellation in minimally invasive gynecologic surgery. Oncologist
2015;20:1274-1282
6
Food and Drug Administration. Quantitative assessment of the prevalence of unsuspected uterine
sarcoma in women undergoing treatment of uterine fibroids. Summary and key findings. April 17, 2014
(http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589.pdf).
7
Parker WH, Kaunitz AM, Pritts EA, et al. U.S. Food and Drug Administration’s guidance regarding
morcellation of leiomyomas: well-intentioned, but is it harmful for women? Obstet Gynecol 2016;127:18-
22
8
Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs
abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am
J Obstet Gynecol 2015;212:591.e1-591.e8
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9
Kamp, J. Hospital chain HCA prohibits power morcellation for uterine fibroids. The Wall Street Journal.
November 25, 2014. (http://online.wsj.com/articles/hospital-chain-hca-prohibits-power-morcellation-for-
uterine-fibroids-1416948061)
10
Kamp, J. Aetna to stop covering routine use of power morcellator. The Wall Street Journal. May 5,
2015. (http://www.wsj.com/articles/aetna-to-stop-covering-routine-use-of-power-morcellator-
1430838666)
11
Truong M, Advincula A. The Extracorporeal C-Incision Tissue Extraction (ExCITE) Technique. OBG
Manag. 2014; 26(11):56.
12
Salvay H. FDA Approved Tissue Extraction System. January 8, 2015. (https://youtu.be/kABmjlSdbaA)
13
Harris JA, Swenson CW, Uppal S, et al. Practice patterns and postoperative complications before and
after US Food and Drug Administration safety communication on power morcellation. Am J Obstet
Gynecol 2016;214:98.e1-98.e13

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Figure Legends
Figure 1. Low Fidelity Contained Tissue Extraction Simulation Model

Figure 2. Mean Extraction Times Improved by 45% After the Intervention

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Figure 3. Mean Extraction Times Improved for All Levels of Training

Figure 4. Mean Levels of Confidence Increased

1.897
4.086
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Pre-Intervention Post-Intervention
Level of Confidence (5 pt Likert scale)
PGY-1,2,3,4
p=0.0001
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Figure 5. Mean Levels of Confidence Levels Increased Among All Levels of Training

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Creator Saad, Christina Adel (author)

Core Title Use of a low fidelity contained manual tissue extraction simulation to improve gynecology resident competence and confidence

School Keck School of Medicine

Degree Master of Science

Degree Program Clinical, Biomedical and Translational Investigations

Publication Date 07/01/2016

Defense Date 06/20/2016

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag gynecology,morcellation,OAI-PMH Harvest,simulation,tissue extraction

Format application/pdf (imt)

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Cortessis, Victoria (committee chair), Kaufman, Wayne A. (committee member), Templeman, Claire (committee member)

Creator Email christinaadelsaad@gmail.com

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c40-260318

Unique identifier UC11279423

Identifier etd-SaadChrist-4498.pdf (filename),usctheses-c40-260318 (legacy record id)

Legacy Identifier etd-SaadChrist-4498-0.pdf

Dmrecord 260318

Document Type Thesis

Format application/pdf (imt)

Rights Saad, Christina Adel

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Access Conditions The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...

Repository Name University of Southern California Digital Library

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