Amy L. Brien, MD
Mayo Clinic Health System MANKATO, MINNESOTA, United States
This study was conducted after obtaining Institutional Review Board
approval.
Financial disclosure : The authors report no conflict of
interest.
Funding : The study was funded by the Mayo Clinic OBGYN Quality
Committee grant for department quality improvement projects. Awarding
body had no role in the study design, collection and analysis of data,
interpretation or writing of the report.
Corresponding author: Tarek Khalife, MD; email:
khalife.tarek@mayo.edu;
1025 Marsh Street, Mankato, MN 56001. Cell phone: 313-680-4224
Word count: 497
Keywords: Hysterectomy, Infection, Uterine Manipulator,
Rectovaginal, contamination.
Objective: About 538,793 hysterectomies are performed annually
in the US alone and 62% of those are done
laparoscopically.1 Surgical site infection (SSI)
following a hysterectomy is a recognized complication and rates range
from 1.8-3.9% with a lower rate being associated with minimally
invasive surgery (MIS) routes. 2 Surgical site
infection is associated with significant morbidity, mortality, and high
healthcare expenditure. Thereby, its closely scrutinized by the Centers
for Disease Control and the National Surgical Quality Improvement
Program (NSQIP).3 Research endeavors with a focus on
the reduction of surgical infectious morbidity resulted in several
bundles and care pathways that are aimed to minimize that risk.
Laparoscopic benign hysterectomy surgeons commonly use a uterine
manipulator to reduce the risk of genitourinary tract injuries and
improve visualization during the procedure, especially in patients with
complex pathology. Nonetheless, the utilization of the tool is not
without risks.4
Due to the proximity of the uterine manipulator handle and shaft from
the anal orifice during the manipulation maneuvers, contact
contamination of the tool by coliform bacteria from the anus is highly
likely. A recent study reported that 60.7% of bacteria causing
intra-abdominal infections are from intestinal or vaginal bacteria which
highlights the rectovaginal contamination hypothesis as a risk
factor.5
In this pilot study our aim was to evaluate the effect of applying an
anal occlusive drape (AOD) prior to the laparoscopic hysterectomy prep
to decrease the risk of potential rectovaginal contamination and
resultant risk of infectious morbidity after laparoscopic hysterectomy.
Study Design: A quality improvement study using a
pre-post-intervention study design was conducted at a community health
system in Minnesota. The study was reviewed and approved by the
Institutional Review Board. Figure 1 demonstrates the AOD components and
application instructions. Baseline SSI rates were calculated from
January 1st, 2020, till December
31st,2021 through chart review and the National
Surgical Quality Improvement Program data registry for 178 patients. All
total laparoscopic or robotic hysterectomy patients done between March
1st, 2022, and March 1st, 2023, were included and
followed for the 30-day surveillance period (post-intervention group).
The primary outcome measure was the reduction of the risk of SSI by
20%. A similar reduction in urinary tract infections (UTI) and use of
antibiotics in the 30-day postoperative period would be expected.
Results: Eighty-one patients were included in the study period.
SSI rates dropped from 3.4% to 1.2% (63%) (Fischer exact test P=
0.4397). Similar decreases in UTI rates from 4.5 to 2.5% (45%) and the
use of post-operative antibiotics prescribing from 17.4% to 6.2% were
noted. No perianal skin irritation or allergic reaction was reported.
The preparation process did not increase the average In-Room to Incision
time of 35 min.
Conclusion : Rectovaginal contamination may be a factor in the
pathogenesis of hysterectomy-related infectious morbidity. Applying an
Anal Occlusive Drape may help reduce this risk. The study is
underpowered to detect statistical significance and plans for
accumulating additional patients are underway Future research efforts
will focus on the widespread implementation of the AOD prep across the
health system sites to confirm validity and generalizability.