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临床试验/NCT04205149
NCT04205149撤回不适用

Post-Operative Recovery After Cesarean Hysterectomy Using the Enhanced Recovery After Surgery (ERAS) Pathway

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家开始时间: 2020年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Oral morphine equivalents

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Underwent a cesarean hysterectomy at Beth Israel Deaconess Medical Center

排除标准

  • Patient records not accessible at Beth Israel Deaconess Medical Center

结局指标

主要结局

Oral morphine equivalents

时间窗: Until study completion, expected 2 years

Oral morphine equivalent use during first 72 hours after surgery

次要结局

  • Pain scores(Until study completion, expected 2 years)
  • Time to urinary foley removal(Until study completion, expected 2 years)
  • Length of stay(Until study completion, expected 2 years)
  • Time to ambulation(Until study completion, expected 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ai-ris Collier

Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (1)

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