Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04205149 |
| Other study ID # |
2019P000821 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2020 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Beth Israel Deaconess Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The enhanced recovery after surgery (ERAS) pathway is a well-described evidence-based
protocol to optimize patient post-operative recovery. Patients undergoing cesarean
hysterectomies are a unique surgical population. These procedures are most commonly performed
for patients with placenta accreta spectrum or severe postpartum hemorrhage. In recent
studies examining the effectiveness of the ERAS pathway, post-operative cesarean patients
experienced decreased average inpatient opioid exposure without an increase in pain scores,
early mobilization and nutrition targets without increases in adverse outcomes after program
implementation. Post-operative hysterectomy patients with gynecologic indications experienced
shorter lengths of stay and decreased opioid consumption. Additionally, patients have
significantly higher satisfaction scores. The investigators suspect that this population may
also benefit similarly.
This research is a pre- and post- study to assess and describe surgical outcomes and
parameters surrounding patients' post-operative recovery and experience before and after the
ERAS pathway is implemented at a high volume placenta accreta spectrum Center of Excellence.
Description:
The enhanced recovery after surgery (ERAS) pathway has emerged as an evidence-based protocol
to optimize patient post-operative recovery. It utilizes multimodal analgesia to decrease
narcotic use and promote streamlined patient-centered care that helps to reduce blood loss,
expedite patients' return to baseline function, and prepare patient expectations around
surgery. This pathway has been well studied in several surgical populations, including
gynecologic (post hysterectomy) and obstetric (post cesarean) patients.
Patients undergoing cesarean hysterectomies are a unique surgical population. These
procedures are most commonly performed for patients with placenta accreta spectrum or severe
postpartum hemorrhage. Ideally, women with suspected placenta accreta spectrum diagnosed
antenatally should be delivered at a level III or IV center with placenta accreta spectrum
Centers of Excellence accreditation to improve outcomes. With the rates of placenta accreta
spectrum increasing, these Centers of Excellence could consider applying principles of the
ERAS pathway to the operative management of these patients. Other populations have seen
decreases in opioid use, quicker baseline recovery, shorter hospital stays and overall
improved patient satisfaction with the use of the ERAS pathway.
In recent studies examining the effectiveness of the ERAS pathway, post-operative cesarean
patients experienced decreased average inpatient opioid exposure without an increase in pain
scores, early mobilization and nutrition targets without increases in adverse outcomes after
program implementation. Post-operative hysterectomy patients with gynecologic indications
experienced shorter lengths of stay and decreased opioid consumption. Additionally, patients
have significantly higher satisfaction scores. The investigators suspect that this population
may also benefit similarly.
This research is a pre- and post- study to assess and describe surgical outcomes and
parameters surrounding patients' post-operative recovery and experience before and after the
ERAS pathway is implemented at a high volume placenta accreta spectrum Center of Excellence.
The study design involves a retrospective analysis of variables related to postpartum
recovery. The primary outcome will be oral morphine equivalents as a proxy for narcotic use
in the first 72 hours post-operatively, comparing pre- to post-ERAS implementation.
Investigators will also collect data on pain scores, time to ambulation, time to foley
catheter removal and first void, and length of stay. Investigators will also collect data on
post-operative complications including surgical site infection, urinary tract infection,
transfusion, unplanned return to OR, pneumonia, pulmonary embolism, unplanned intubation,
cardiac arrest, readmission within 30 days, sepsis, and death within 30 days.
