Enhanced Recovery After Cesarean Hysterectomy

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04205149
Collaborator
(none)
92
1
27.6
3.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: ERAS post-operative pathway

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
92 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Operative Recovery After Cesarean Hysterectomy Using the Enhanced Recovery After Surgery (ERAS) Pathway
Actual Study Start Date :
Feb 13, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Pre-ERAS implementation arm

Post-ERAS implementation arm

Other: ERAS post-operative pathway
ERAS Pathway

Outcome Measures

Primary Outcome Measures

  1. Oral morphine equivalents [Until study completion, expected 2 years]

    Oral morphine equivalent use during first 72 hours after surgery

Secondary Outcome Measures

  1. Pain scores [Until study completion, expected 2 years]

    Likert scale 0-10 (0=no pain, 10=most pain) during first 72 hours after surgery

  2. Time to ambulation [Until study completion, expected 2 years]

    Hours from surgery to first ambulation

  3. Time to urinary foley removal [Until study completion, expected 2 years]

    Hours from surgery to foley catheter removal

  4. Length of stay [Until study completion, expected 2 years]

    Days of inpatient hospitalization after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Underwent a cesarean hysterectomy at Beth Israel Deaconess Medical Center
Exclusion Criteria:
  • Patient records not accessible at Beth Israel Deaconess Medical Center

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ai-ris Collier, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT04205149
Other Study ID Numbers:
  • 2019P000821
First Posted:
Dec 19, 2019
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 2, 2022