Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection: Study Protocol for 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
- 36
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
Commonly the pressure of about 14 mmHg is applied during laparoscopic liver resection (LLR) with moderate neuromuscular blockade. Lowering the pneumoperitoneum pressure combined with deep neuromuscular blockade may sustain optimal operating space with providing better short-term postoperative results. It has been proved in randomized controlled trials in colorectal or bariatric patients, however there is lack of similar data for laparoscopic liver resection. Doubts about lowering the pneumoperitoneum pressure too hasty are supported by apprehension of worse bleeding control during liver parenchyma transection and its impact on postoperative results.
The aim of the trial is to assess the impact of standard (14 mmHg; arm 1) versus low (10 mmHg; arm 2) pneumoperitoneum pressure on intraoperative blood loss, what will be the primary outcome. As secondary endpoints following outcomes will be measured: quality of operating space, intraoperative adverse events, quality of recovery, postoperative renal function, 30-day postoperative complications rate, length of hospital stay. The investigators assume that lower pneumoperitoneum provides non-inferior blood loss control during laparoscopic liver resection with better postoperative results.
详细描述
After signing the informed consent patients will be randomized into 2 groups. Randomization will be conducted by investigators via drawing a sealed envelope with computer-generated intervention code at the Department just before patient transfer to the operating theatre. There will be two study arms with 1:1 fashion
For both trial arms additional routine elements of perioperative anesthesia care will be defined:
- low central vein pressure, aimed for 5 ± 2 mmHg with restrictive fluid therapy
- ventilation in a volume-controlled mode without intraoperative high positive end-expiratory pressure (PEEP)
- invasive arterial blood pressure monitoring with maintaining mean arterial pressure ≥ 60 mmHg
- maintaining hemoglobin concentration > 8g/dl
- maintaining normothermia and normoglycemia
- maintaining oxygenation >94%, in case of hypercapnia with respiratory acidosis, the respiratory rate and tidal volume will be stepwise increased
The surgeon will be blinded to the study arm and level of pneumoperitoneum pressure.
The blood loss during liver parenchyma transection and total procedure blood loss will be reported based on the amount of sucked outside intraperitoneal fluids after liver transection and after procedure without volume inserted for intraperitoneal irrigation. The estimated blood loss will be measured in milliliters. Patients who are converted to open surgery are excluded from the analysis of the primary end-point.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients scheduled to perform elective laparoscopic major liver resection
- •Age of 18 years or older
- •Signed informed consent
排除标准
- •Severe cardiopulmonary disease
- •Severe renal disease
- •Liver cirrhosis
- •Emergency surgery
- •Pregnancy
- •Patient's refusal of participation
研究组 & 干预措施
Standard pneumoperitoneum pressure
Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure
干预措施: Pneumoperitoneum 14mmHg (Procedure)
Low pneumoperitoneum pressure
Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure
干预措施: Pneumoperitoneum 10mmHg (Procedure)
结局指标
主要结局
Intraoperative blood loss
时间窗: Intraoperative
Intraoperative blood loss in ml
次要结局
- Intraoperative adverse events(Intraoperative)
- Risk of postoperative complications(30 postoperative days)
- Quality of postoperative rehabilitation(Postoperative day 1, Postoperative day 3, Postoperative day 5)
- Quality of the operating space(Intraoperative)
- Length of hospital stay(From date of surgery until the date of disscharge or date of death from any cause, whichever came first, assessed up to 100 days)
研究者
Wacław Hołówko
Principal Investigator
Medical University of Warsaw