Same Day Discharge After Minimally-invasive Sacrocolpopexy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This is a prospective cohort study evaluating safety, cost and patient satisfaction with SDD
      for patients undergoing minimally invasive sacrocolpopexy for pelvic organ prolapse. A
      prospectively collected, historical control group who underwent the same surgical procedure
      will be utilized to compare these outcomes when applicable. SDD will be facilitated in part
      by a utilizing novel patient education video created for this study and implementing an ERAS
      pathway. All patients meeting eligibility criteria will be approached for study
      participation. Outcomes will be assessed on POD 0/1 and at the routine post-operative follow
      up visit, generally at 6 weeks after surgery.
    

Detailed description: 
      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.
    

Intervention name(s): Same day discharge
Intervention type(s): Other
Intervention description(s): Patients will be discharged home from the hospital on the day of her surgery.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective cohort study with historical controls
Masking: None (Open Label)
Primary purpose: Health Services Research