Impact of Total Coronary Revascularization Via Left Anterior Thoracotomy (TCRAT) vs. Robotic-Assisted Harvesting of Left Internal Thoracic Artery on Hospital Stay (ITcrats)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- The length of hospital stay
研究概览
简要总结
The two types of total coronary revascularization via left anterior thoracotomy (TCRAT) might have their potential benefits and disadvantages. The proposed randomized clinical trial here will compare 'RA-TCRAT' with 'Nonrobotic TCRAT' procedures concerning effects on hospital stays, overall healthcare costs, safety, and feasibility. If the two TCRAT procedures are comparably effective and safe, the 'Nonrobotic TCRAT' procedure is probably preferred as it seems easier to use. However, if the 'Nonrobotic TCRAT' procedure is less effective and less safe than the "robotic TCRAT,' that procedure should be preferred.
详细描述
Rationale
A recent study involving 1,195 patients from the Society of Thoracic Surgeons Registry undergoing robotic-assisted-minimally-invasive direct coronary artery bypass (RA-MIDCAB) by 114 surgeons between 2014 and 2019 showed that surgeons can quickly reduce complication rates by building up the learning curve. It is yet unclear if robotic-assisted harvesting of the left internal thoracic artery (RA-LITA) would offer a benefit over total coronary revascularization via left anterior thoracotomy (TCRAT) in terms of the postoperative hospital stay and cost of healthcare. That raises the need to examine the impact of RA-LITA compared with TCRAT on these crucial clinical outcomes.
Objective
The primary objective of this prospective randomized clinical trial (RCT) is, compared with TCRAT, to examine the impact of robotic-assisted coronary artery bypass graft (RA-CABG) on the length of hospital stay in diverse patients scheduled for elective surgical coronary revascularization.
Secondary objectives include identifying the overall costs and charges of healthcare, operating room and intensive care unit (ICU) stays, postoperative bleeding, need for re-explorative surgery or transfusion, postoperative major adverse cardiovascular and cerebrovascular events (MACCE)], acute kidney injury (AKI), and surgical related complications and 30-days and 3-months need for hospital re-admission and survival after adult cardiac surgical coronary revascularization using cardiopulmonary bypass (CPB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Further minimization of bias will be achieved by involving two independent investigators. The researcher responsible for performing the surgery will perform the Randomization directly before the start of anesthesia. A second investigator, who will not be blinded for the randomization arm, will score the primary and secondary postoperative outcome measures.
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
- •Scheduled for any type of elective minimally invasive coronary revascularization surgery.
- •Using CPB.
- •General anesthesia is provided in an endotracheally intubated patient
排除标准
- •Planned for coronary revascularization surgery without CPB;
- •Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
- •LVEF less than 35%;
- •Preoperative cardiogenic shock;
- •Pregnancy;
- •Scheduled for re-do or emergency surgery;
- •Consent for another interventional study during anesthesia;
- •No written informed consent;
- •Preoperative need for mechanical circulatory support;
- •Preoperative need for invasive ventilatory support;
研究组 & 干预措施
Nonrobotic TCRAT
Nonrobotic TCRAT for CABG
干预措施: Nonrobotic TCRAT (Procedure)
Robotic TCRAT
Robotic TCRAT for CABG
干预措施: Robotic TCRAT (Procedure)
结局指标
主要结局
The length of hospital stay
时间窗: For 120 days from surgery
The primary outcome is the length of hospital stay, defined as the time from surgery until discharge or in-hospital death.
次要结局
- Any cause of in-hospital death during the same admission(For 120 days from surgery until death or hospital discharge)
- Overall costs and charges(For 120 days from surgery until hospital discharge or death)
- The operating room stay(For 12 hours from entrance to the operating rooms)
- The postoperative ICU stay(For 120 days from surgery)
- The need for re-explorative surgery during the same admission.(For 120 days from surgery)
- Perioperative need for packed red blood cells (PRBCs) transfusion(For 72 hours from surgery)
- Perioperative need for fresh frozen plasma (FFP) transfusion(For 72 hours from surgery)
- Perioperative need for platelets concentrate transfusion(For 72 hours from surgery)
- Perioperative need for cryoprecipitates transfusion(For 72 hours from surgery)
- Perioperative need for recombinant factor VII administration(For 72 hours from surgery)
- The cumulative postoperative chest tube outputs(For 48 hours after surgery.)
- Need to intraoperative conversion to sternotomy.(For 12 hours from the begining of surgery)
- Graft's pulsatility index (P.I.).(Intraoperatively after discontinuation of the CPB)
- The need for postoperative coronary revascularization(For 180 days from surgery)
- In-hospital limb ischemia(For 120 days from surgery until death or hospital discharge)
- The need for any-cause hospital re-admission within 30 days after surgery.(For 30 days after surgery.)
- The need for any-cause hospital re-admission within 90 days after surgery.(For 90 days after surgery.)
- All-cause mortality at 30 days after surgery(For 30 days after surgery)
- All-cause mortality at 90 days after surgery(For 90 days after surgery)
- In-hospital acute myocardial infarction (AMI)(For 120 days from surgery until death or hospital discharge)
- In-hospital acute ischemic stroke(For 120 days from surgery until death or hospital discharge)
- In-hospital acute kidney injury (AKI)(For 120 days from surgery until death or hospital discharge)
研究者
Mohamed R El Tahan
Consultant in Cardiac Anesthesia
Imam Abdulrahman Bin Faisal University