Enhanced Recovery After Cesarean Hysterectomy

Withdrawn

• Conditions: Post-operative Recovery for Cesarean Hysterectomy Patients
• Interventions: Other: ERAS post-operative pathway

• Registration Number: NCT04205149
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

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 Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-02-13
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Underwent a cesarean hysterectomy at Beth Israel Deaconess Medical Center

Exclusion Criteria

• Patient records not accessible at Beth Israel Deaconess Medical Center

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-ERAS implementation arm	ERAS post-operative pathway	-

Primary Outcome Measures

Name	Time	Method
Oral morphine equivalents	Until study completion, expected 2 years	Oral morphine equivalent use during first 72 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Pain scores	Until study completion, expected 2 years	Likert scale 0-10 (0=no pain, 10=most pain) during first 72 hours after surgery
Time to urinary foley removal	Until study completion, expected 2 years	Hours from surgery to foley catheter removal
Length of stay	Until study completion, expected 2 years	Days of inpatient hospitalization after surgery
Time to ambulation	Until study completion, expected 2 years	Hours from surgery to first ambulation

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States