A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction Based on Time of Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Number of Participants with Post-operative hospital readmissions
研究概览
简要总结
The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.
详细描述
Traditionally patients undergoing mastectomy with immediate implant-based breast reconstruction were admitted to the hospital overnight. However, recent retrospective studies utilizing ERAS protocols have reported same day discharge as a possibility for this patient population. ERAS protocols for breast cancer surgery and reconstruction are becoming more popular. This along with the increasing utilization of prepectoral breast reconstruction that is associated with less postoperative pain and opioid use, are promising avenues to decrease the need for overnight hospital stay. If it can be shown that discharge on the same day of surgery does not pose any major risks compared to discharge on post-operative day one, there is the potential to decrease length of hospital stay, improve hospital capacity and dramatically decrease costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo immediate, (unilateral or bilateral)implant-based breast reconstruction following mastectomy for breast cancer or prophylaxis at the University of Colorado Anschutz Medical Campus and Highlands Ranch Campus.
- •Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
- •All adult (>18 years old), female patients who will undergo mastectomy for breast cancer or prophylaxis and immediate implant-based reconstruction who are able to complete surveys independently will be eligible for the study.
- •English and Spanish speaking
- •Patients will be included regardless of their current chemoradiation plan
排除标准
- •Age > 80 years
- •suboxone use
- •documented substance use disorder as defined by the DSM-5 (I.e. alcohol use disorder, opioid use disodrer, cocaine use disorder, etc). Marijuana use will not be considered a substance use disorder
- •OSA requiring CPAP
- •recent pneumonia (within 6 weeks)
- •BMI > 45 kg/m2 with any co-morbid condition that is not well controlled
- •poorly controlled diabetes (HgbA1c > 9)
- •Not English or Spanish speaking
结局指标
主要结局
Number of Participants with Post-operative hospital readmissions
时间窗: Up to 30 Days
Assessed by patient report
Number of Participants with Post-operative re-operation
时间窗: Up to 30 Days
Assessed by patient report
Rate of post-operative complications surgical site infection
时间窗: Up to 30 Days
Assessed by patient report
Number of Participants with Post-operative hematoma
时间窗: Up to 30 Days
Assessed by patient report
Number of Participants with Post-operative blood clots
时间窗: Up to 30 Days
Assessed by patient report
Number of Participants with Post-operative emergency department visits
时间窗: Up to 30 Days
Assessed by patient report
次要结局
- Pain Score(Up to 30 Days)
- Opioid adverse effects(Up to 30 Days)
- Quality of life perceptions: QoR-15(Up to 30 Days)
- Quality of life perceptions: PROMIS-29(Up to 30 Days)
- Opioid Consumption(Post-Operative day 7)
- Discharge perceptions(Post-Operative day 7)