Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Primary postoperative ileus (POI)
研究概览
简要总结
Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.
It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.
详细描述
Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)
Two arms:
GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.
Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.
ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program
排除标准
- •Age <18 yr
- •Emergency surgery
- •Patients who do not understand, read or communicate in either French or English
- •Patients who had undergone esophageal or gastric surgery
- •Esophageal pathology (esophageal varices or cancer)
- •Patients with coarctation of the aorta or aortic stenosis
- •Chronic atrial fibrillation
- •Preoperative bowel obstruction
- •Coagulopathies
- •Chronic use of opioids
结局指标
主要结局
Primary postoperative ileus (POI)
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 days
Patients will be considered having primary POI if at least one symptom, for each of the following criteria, will be reported: i. vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet.
次要结局
- Intraoperative hemodynamic measurements(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Intraoperative and postoperative fluids and blood products required(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Vasoactive agents required(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Urinary output(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Intraoperative and postoperative urinary output(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Intraoperative and Postoperative opioid consumption(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Postoperative nausea and vomiting (PONV)(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Time spent out of bed(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Postoperative complications (Clavien Classification)(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Patients' weight(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Quality of surgical recovery score(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Readiness to be discharged(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Length of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
研究者
Gabriele Baldini, MD, MSc, Assistant Professor
MD, MSc, Anesthesiologist, Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre