Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Incidence of severe postoperative complications
研究概览
简要总结
Liver resection is an important surgical treatment for patients with liver diseases. Despite advances in surgical and anesthetic management, postoperative complications remain a major concern and may affect patient recovery. Maintaining stable blood circulation during surgery is an important part of perioperative care.
Terlipressin is a vasoactive medication that may help maintain blood pressure and improve hemodynamic stability during surgery. However, the relationship between intraoperative continuous terlipressin infusion and postoperative outcomes after laparoscopic hepatectomy remains unclear.
This prospective observational cohort study aims to evaluate the association between continuous intraoperative terlipressin infusion and postoperative severe complications in patients undergoing laparoscopic hepatectomy.
Patients undergoing laparoscopic hepatectomy at the First Affiliated Hospital of Sun Yat-sen University will be enrolled and followed according to a predefined study protocol. Perioperative clinical information, anesthetic management data, terlipressin exposure, and postoperative outcomes will be collected and analyzed. The primary outcome is the occurrence of severe postoperative complications, defined as Clavien-Dindo grade III or higher complications.
详细描述
Liver resection is an important surgical procedure for the treatment of patients with various liver diseases. Although advances in surgical techniques and perioperative management have improved outcomes, postoperative complications remain a significant concern after major abdominal surgery. Perioperative hemodynamic management plays an important role in maintaining adequate organ perfusion and may influence postoperative recovery.
Terlipressin is a vasoactive medication that increases vascular tone and may help maintain hemodynamic stability during surgery. In clinical practice, terlipressin may be administered during surgery based on the judgment of the attending anesthesiologist. However, the association between intraoperative continuous terlipressin infusion and postoperative outcomes in patients undergoing laparoscopic hepatectomy remains unclear.
This prospective observational cohort study was designed to evaluate the association between continuous intraoperative terlipressin infusion and postoperative severe complications in patients undergoing laparoscopic hepatectomy. Patients undergoing laparoscopic hepatectomy will be prospectively enrolled according to predefined eligibility criteria and followed according to the study protocol.
Clinical characteristics, perioperative management information, intraoperative terlipressin exposure, and postoperative outcomes will be collected prospectively. The primary objective of this study is to assess whether intraoperative continuous terlipressin infusion is associated with the incidence of severe postoperative complications after laparoscopic hepatectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective laparoscopic partial hepatectomy
- •Provided written informed consent
排除标准
- •Inability to tolerate the planned surgical procedure based on pre-anesthetic assessment
- •Severe hepatic dysfunction (Child-Pugh class B or higher)
- •Severe renal dysfunction (blood urea nitrogen > 9 mmol/L or serum creatinine > 178 μmol/L)
- •Significant cardiovascular or cerebrovascular disease, including active coronary artery disease, severe valvular stenosis, hypertrophic obstructive cardiomyopathy, or history of extensive cerebral infarction
- •Known allergy to study medications
- •Body mass index (BMI) > 35 kg/m² or < 18 kg/m²
- •Hemoglobin level < 90 g/L
- •Pregnancy or lactation
- •Participation in another clinical trial within the preceding 3 months
- •Any other condition considered inappropriate for study participation by the investigator
研究组 & 干预措施
Terlipressin Exposure Group
Patients who received continuous intraoperative terlipressin infusion during laparoscopic hepatectomy according to the clinical judgment of the attending anesthesiologist. Terlipressin administration was not assigned by the study protocol and was determined based on routine clinical practice.
干预措施: terlipressin (Drug)
Non-Terlipressin Exposure Group
Patients who underwent laparoscopic hepatectomy and did not receive continuous intraoperative terlipressin infusion during surgery. The absence of terlipressin administration was determined by routine clinical practice.
结局指标
主要结局
Incidence of severe postoperative complications
时间窗: Within 30 days after surgery
Severe postoperative complications will be defined as Clavien-Dindo grade III or higher complications occurring after laparoscopic hepatectomy.
次要结局
未报告次要终点
研究者
Xuyu Zhang
Professor of Anesthesiology
First Affiliated Hospital, Sun Yat-Sen University