NCT07176715招募中不适用
Same-Day Colectomy: is it Safe for Patients?
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Hospital Readmission
研究概览
简要总结
This is a prospective cohort study of outcomes of patients undergoing outpatient colorectal surgery at a single institution to study outpatient colectomy as a viable treatment option for a select group of patients requiring colon and rectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70
- •Undergoing robotic-assisted right colectomy, sigmoidectomy, or low anterior resection.
- •Able to perform greater than 4 metabolic equivalents (METS) without shortness of breath
- •Must have a designated adult who can care for them at home postoperatively until their in-person clinic visit
- •Access to a cell phone or computer and running water.
- •Successfully completed pre-operative and post-operative education
- •Medical criteria:
- •Well controlled hypertension with systolic blood pressure < 140 controlled by less than two medications which they are compliant with
- •Well controlled diabetes on oral agents only with blood glucose level < 180 on daily checks
- •Anti-platelet agents including aspirin, clopidogrel, prasugrel, ticagrelor or ticlopidine will be stopped 7 days preoperatively and restarted on postoperative day
排除标准
- •7 for specific exclusion criteria regarding antiplatelet agents.
- •Exclusion Criteria:
- •Medical criteria:
- •Neurocognitive deficits not allowing for adequate preoperative education
- •Congestive heart failure with EF < 45%
- •Symptomatic aortic stenosis causing heart failure, syncope, dyspnea or angina
- •Pulmonary fibrosis or pulmonary hypertension
- •COPD or home oxygen use > 2L
- •Chronic kidney disease of any stage.
- •Lack of a caregiver at home or functionally bed-bound
- •Ultralow pelvic resection
- •Need for ostomy creation intraoperatively
- •Operative time greater than 5 hours as this likely indicates a complex case and dissection necessitating closer monitoring in the hospital
- •Conversion to open procedure intraoperatively
- •Patients receiving antiplatelet agents such as clopidogrel, prasugrel, ticagrelor or ticlopidine within one year of coronary or carotid stent implantation, TAVR or LAAO placement.
- •Patients on therapeutic anticoagulation medications such as warfarin, Eliquis, Xarelto, Enoxaparin
- •Current tobacco use
- •Patients who were unable to complete preoperative education, do not feel comfortable with care at home, or do not have an available caregiver for the first 7 postoperative days
- •Any surgical history that would preclude safe abdominal entry for robotic surgery
研究组 & 干预措施
Same Day Colectomy
Experimental
干预措施: Same-Day Colectomy (Other)
结局指标
主要结局
Hospital Readmission
时间窗: 30-Days post-procedure
The primary outcome of this study is the 30-day rate of readmission to the hospital following same day colectomy
次要结局
- rate of surgical site infection(30-days Post Procedure)
- rate of deep surgical infection(30-days Post Procedure)
- rate of anastomotic leak(30-days Post-procedure)
- rate of bleeding requiring transfusion(30-Days Post-Procedure)
- rate of postoperative ileus(30-Days Post-Procedure)
- rate of reoperation(30-Days Post-Procedure)
- reintervention(30-Days Post-Procedure)
- rate of acute kidney injury or renal failure(30-Days Post-Procedure)
- rate of reintubation or need for prolonged ventilation(30-Days Post-Procedure)
- Rate of mortality(30-Days Post Procedure)
研究者
Eugene Kim
Assistant Clinical Professor, Clinical Series
University of Arizona
研究点 (2)
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