Same Day Discharge After Minimally-invasive Sacrocolpopexy

Enhanced recovery after surgery (ERAS) pathways play a critical role in the delivery of
high-quality surgical care. These protocols incorporate multiple perioperative patient
interventions including preemptive analgesia, measures to reduce postoperative nausea and
emesis, fluid balance aimed at euvolemia, and both early ambulation and oral intake. ERAS
pathways are significant because they have been shown to shorten recovery, decrease hospital
stay, reduce complications/nosocomial infections, and conserve resources.1-20 Same-day
discharge (SDD) is a central aspect of enhanced recovery pathways.

SDD and ERAS protocols are part of a new initiative within the Women's Health Institute, and
their application for gynecologic surgery is of increasing interest across the country.1-19
To date, the focus of studies has largely been on laparoscopic and robotic hysterectomy in
the benign and gynecologic oncology literature. Studies have consistently demonstrated both
feasibility and safety of SDD after laparoscopic and robotic hysterectomy, with no
significant increase in complications or readmissions as compared to discharge on
postoperative day (POD) 1. In fact, a recent systematic review by Korsholm et al of 15
observational studies with nearly 12,000 patients revealed SDD is feasible, at a rate of
nearly 80%, when patients are properly selected and careful surgical planning is performed.3
Studies have also demonstrated high patient satisfaction10,12 and less cost18 with SDD after
minimally invasive hysterectomy. SDD has been applied in other minimally invasive gynecologic
procedures, such as minimally invasive myomectomy, with low readmission rates (0.6% within 48
hours, 1.4% over 3 months).20

ERAS pathways can have an important role in other areas of gynecologic surgery. In the field
of urogynecology, quality of life reconstructive surgery is often performed to address
symptoms of pelvic organ prolapse, urinary incontinence, and/or fecal incontinence. A
prospective study by Kalogera et al evaluated the impact of an ERAS pathway for patients
undergoing vaginal reconstructive surgeries for pelvic organ prolapse versus historical
controls.21 In this cohort, patient satisfaction with perioperative care was high, mean
duration of hospital stay was significantly reduced, and there were no differences in 30 day
outcomes. In a case series by Zakaria and Levy, an ERAS pathway was utilized after vaginal
hysterectomy, which permitted SDD in 96% of patients.19 Notably, only 5 of the 1071 patients
required readmission or emergency room evaluation within 30 days of surgery. Taken together,
these studies provide support for the application of ERAS pathways in urogynecology, where
well-selected surgical candidates are undergoing surgeries appropriate for SDD.

Yet, to date, only one research study has investigated the role of SDD after minimally
invasive sacrocolpopexy. A sacrocolpopexy is a surgery for pelvic organ prolapse in which a
bridging piece of mesh is utilized to suspend the vaginal cuff to the anterior longitudinal
ligament overlying the sacral promontory. This is an extensively studied and highly effective
surgical technique to correct pelvic organ prolapse and is a mainstay in the field of
urogynecology. A study by Faucheron et al evaluated SDD for robotic and laparoscopic ventral
rectopexy, a similar mesh-augmented procedure that is performed for rectal prolapse, and
concluded that SDD is feasible and safe.22 A preliminary study by Lloyd et al performed at
the Cleveland Clinic within the Female Urology division investigated SDD after minimally
invasive sacrocolpopexy (article in press). In this study, SDD was achieved in 10 of 12
patients (83.3%). The two patients who did not have SDD were due to case completion after
6PM, a preset case completion requirement. Outcomes were also retrospectively compared
between patients who underwent SDD (N= 10) and patients who stayed overnight (N=30). Only one
patient had an emergency department visit on POD 20, due to an unrelated mechanical fall.
Importantly, there were no major complications in either group requiring procedural
interventions, new prescriptions, or additional interventions. Recently, a study by Kisby et
al was published examining SDD after robotic-assisted sacrocolpopexy. In this retrospective
study, 80 women underwent SDD compared to 192 who were discharged on >/=POD 1.23 This study
found no difference in unplanned provider visits, emergency department visits or readmissions
between the groups.

The investigators hypothesize that an ERAS protocol utilizing SDD for minimally invasive
sacrocolpopexy is as safe as those that utilize discharge on POD 1 while incurring less total
procedure-related costs and being acceptable as a post-op management plan for patients. The
objective of this study is to provide data which are necessary to widely implement SDD after
a minimally invasive sacrocolpopexy. The results of this research will have a significant
impact on increasing patient satisfaction, minimizing resource utilization, and improving
clinical practice patterns in the field of urogynecology, both for this procedure and
potentially other surgeries within our subspecialty.

Specific Aims Aim 1. To compare the incidence of adverse events in patients following a SDD
protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD
1.

The investigators hypothesize that there is no difference in the incidence of adverse events
between SDD compared to discharge on POD 1 after minimally invasive sacrocolpopexy. Using the
Epic electronic medical record (EMR), the investigators will evaluate 1) the number of
unscheduled office visits, patient-initiated calls for a surgery-related complication,
emergency department visits, and readmissions/reoperations of patients who had a SDD protocol
and 2) the severity of any adverse events using the Clavien Dindo Scale. The investigators
will utilize patient phone calls to inquire about any of the aforementioned events outside of
our institution. The investigators will compare incidence of postoperative adverse events
between patients undergoing SDD versus a historical control group who were discharged on POD
1.

Aim 2. To compare the total procedure-related costs associated with SDD compared to discharge
on POD 1 for minimally invasive sacrocolpopexy.

The investigators hypothesize that the total costs associated with SDD following minimally
invasive sacrocolpopexy is less than the same procedure with discharge on POD 1. The
investigators will utilize data from the billing function of Epic EMR to compare total
procedure-related costs for each approach to minimally invasive sacrocolpopexy.

Aim 3. To determine patient satisfaction with SDD after minimally invasive sacrocolpopexy.

The investigators hypothesize that patients will be satisfied with SDD after minimally
invasive sacrocolpopexy. The investigators plan to address this aim using a series of
validated measures.

Inclusion Criteria:

- Age <80 years old

- Preoperative American Society of Anesthesiologists grade I (normal healthy patient) or
II (mild systemic disease)

- Access to ancillary care, including phone advice, nurse and outpatient clinic numbers

- Caretaker at home for at least 24 hours post-operatively

- Able to speak and read English

- Has decision-making capacity and able to provide consent for research participation

Exclusion Criteria:

- Laparoscopic, robotic, or open abdominal surgical procedures that require an overnight
admission. This may be due to unanticipated additional intraoperative procedures or
surgical complications such as unintentional cystotomy or enterotomy, hemorrhage, or
anesthetic complication.

- Patients undergoing concomitant laparoscopic colorectal procedures or anal
sphincteroplasty

- Surgery start time after 1:00PM, as previous studies have determined this is
associated with a decreased likelihood of SDD3,14

- Pregnancy or positive hCG testing, which is standard of care preoperative testing