Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.
详细描述
Primary Objectives:
Our study will investigate the feasibility of an accelerated recovery program to minimize length of stay (LOS) and facilitate outpatient surgery for patients undergoing minimally invasive, lower complexity (Kawaguchi-Gayet grade I) liver resection. This program (ARAMIS Hep) will combine minimally invasive surgical (MIS) approaches (robotic OR laparoscopic), enhanced recovery after surgery (ERAS) protocols, and Telehealth to liberalize discharge criteria in a safe manner.
Secondary Objectives:
In addition to demonstrating a reduction in LOS, our study will also provide preliminary data to aid in the broader implementation of this approach. Specifically, we will gain insight into the patient experience, measure patient-reported outcomes on recovery trajectories, and understand barriers to integrating a novel pathway into existing institutional frameworks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor amenable to MIS Kawaguchi-Gayet grade I hepatectomy (see figure 1 below)
- •No evidence of cirrhosis (based on imaging, evidence of portal hypertension, clinical features, or laboratory results)
- •No significant cardiopulmonary disease that would prevent patients from undergoing MIS resection
- •Ability to stay within 50 miles of medical center for immediate postop period
- •Age of 18 years or above - because no adverse event data are currently available on enhanced recovery and early discharge after hepatic resection for patients <18 years of age, children are excluded from this study
- •Ability to understand and the willingness to sign a written informed consent document
- •Non-English-speaking patients are eligible for participation
排除标准
- •Patients who will be excluded include those with:
- •Tumors NOT amenable to MIS Kawaguchi-Gayet grade I hepatectomy
- •Tumors not amenable to MIS or Robotic-assisted surgical resection
- •Evidence of Cirrhosis on imaging, clinically, or lab testing
- •Inability to stay within 50 miles of the Cancer Center in the immediate post-operative period
- •Age below 18 years
- •Inability to consent for trial/protocol
- •Patients who are pregnant
研究组 & 干预措施
Accelerated Recovery Protocol
Accelerated Recovery after Minimally Invasive Hepatic Surgery (ARAMIS-Hep)
Participants randomized to this arm will undergo a recovery pathway that potentially allows for discharge on the day of surgery (post-operative day 0).
- You will receive a clear liquid diet, be encouraged to ambulate independently, and opioid use will be minimized in the recovery unit.
- You will be assessed in the post-operative recovery unit. If you meet discharge criteria, you will be discharged the afternoon/evening of surgery. If you do not, you will be admitted for overnight observation.
- You will have a telehealth video visit on post-operative days 1 and 2
- You will have in-person clinic visit within 14 days of discharge.
You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery
干预措施: Questionnaires (Behavioral)
Comparison/Control Arm
Standard Post-operative recovery pathway after minimally invasive hepatic surgery.
Participants randomized to this arm will undergo our institution's standard recovery pathway for minimally invasive liver surgery.
- You will be transferred to the Transitional PACU for overnight observation.
- Your diet will be advanced to gastrointestinal "first food" diet on Post-operative Day 1, with opioid weaning and frequent ambulation.
- You will be discharged once criteria are met.
- You will have an in-person clinic visit within 14 days of discharge.
You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; an average of 1 year.
次要结局
未报告次要终点