The Effectiveness of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery in Preserving Innate Immune Homeostasis by Reducing Peritoneal Mesothelial Cell Injury.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mononuclear cell responsiveness ex vivo
研究概览
简要总结
Substudy of the RECOVER trial (a randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery) investigating innate immune homeostasis after laparoscopic colorectal surgery.
详细描述
Rationale: increased intra-abdominal pressure can cause peritoneal mesothelial cell injury either directly or by compression of the capillary vessels, causing a variable degree of ischemia reperfusion injury. The immune system can identify damage to host cells by recognising Danger-Associated Molecular Patterns (DAMPs) that are released upon cell death in an uncontrolled fashion, such as during surgical trauma. DAMPs elicit an immune response similar to the response to invading pathogens and induce an anti-inflammatory immune response strongly related to postoperative recovery, infectious complications and mortality. Low pressure PNP is associated with lower levels of serum pro- and anti-inflammatory cytokines and better preservation of innate immune function.
Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and innate immune function after laparoscopic colorectal surgery.
Study design: a multi-center, blinded, randomized controlled clinical trial.
Study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis.
Intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group A): low pressure PNP (8 mmHg) with deep NMB (PTC 1-2) or the control group (group B): normal pressure PNP (12 mmHg) with moderate NMB (TOF count 1-2).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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 laparoscopic colorectal surgery with a primary anastomosis
- •Obtained informed consent
- •Age over 18 years
排除标准
- •Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
- •Primary colostomy
- •Neo-adjuvant chemotherapy
- •Chronic use of analgesics or psychotropic drugs
- •Use of NSAIDs shorter than 5 days before surgery
- •Known or suspected allergy to rocuronium of sugammadex
- •Neuromuscular disease
- •Indication for rapid sequence induction
- •Severe liver- or renal disease (creatinine clearance <30ml/min)
- •BMI >35 kg/m²
- •Deficiency of vitamin K dependent clotting factors or coagulopathy
研究组 & 干预措施
Low pressure PNP, deep NMB
Low pressure pneumoperitoneum of 8 mmHg with deep neuromuscular block (post tetanic count of 1-2) reached by titration with continuous infusion of Rocuronium bromide.
干预措施: Low pressure pneumoperitoneum (Procedure)
Low pressure PNP, deep NMB
Low pressure pneumoperitoneum of 8 mmHg with deep neuromuscular block (post tetanic count of 1-2) reached by titration with continuous infusion of Rocuronium bromide.
干预措施: Rocuronium bromide (Drug)
Normal pressure PNP, moderate NMB
Normal pressure pneumoperitoneum of 12 mmHg with moderate neuromuscular block (TOF count of 1-2) reached by titration with bolus or continuous infusion of a low dose of Rocuronium bromide.
干预措施: Rocuronium bromide (Drug)
结局指标
主要结局
Mononuclear cell responsiveness ex vivo
时间窗: Before surgery, 24 and 72 hours after surgery
TNFalpha release upon LPS stimulation
次要结局
- Mononuclear cell responsiveness ex-vivo(Before surgery, 24 and 72 hours after surgery)
- HLA-DR mRNA expression(Before surgery, 24 and 72 hours after surgery)
- Serum DAMPs and cytokines(Before surgery, at the end of surgery and 24 hours after surgery)
- Peritoneal histology and HIF1alpha expression(At the start and end of surgery)