Enhanced Recovery After Cesarean Hysterectomy

• ClinicalTrials.gov Identifier: NCT04205149
• Recruitment Status: Withdrawn
• First Posted: December 19, 2019
• Last Update Posted: January 11, 2023
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Ai-ris Collier, Beth Israel Deaconess Medical Center

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
Post-operative Recovery for Cesarean Hysterectomy Patients	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
• Actual Enrollment: 0 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: February 13, 2020
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: June 2022

Groups and Cohorts

Group/Cohort	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 [ Time Frame: Until study completion, expected 2 years ]
   Oral morphine equivalent use during first 72 hours after surgery

Secondary Outcome Measures :

1. Pain scores [ Time Frame: 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 [ Time Frame: Until study completion, expected 2 years ]
   Hours from surgery to first ambulation
3. Time to urinary foley removal [ Time Frame: Until study completion, expected 2 years ]
   Hours from surgery to foley catheter removal
4. Length of stay [ Time Frame: Until study completion, expected 2 years ]
   Days of inpatient hospitalization after surgery

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients undergoing cesarean hysterectomy at Beth Israel Deaconess Medical Center

Criteria

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

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Ai-ris Collier, Principal Investigator, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04205149
• Other Study ID Numbers: 2019P000821
• First Posted: December 19, 2019
• Last Update Posted: January 11, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No