RECOVER Study: the Effect of Low- Versus Normal Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on the Early Quality of Recovery With Perioperative Care According to the Enhanced Recovery Principles
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 3
- 主要终点
- Total score on the Quality of Recovery-40 questionnaire
研究概览
简要总结
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.
详细描述
Rationale: the laparoscopic approach reduced trauma as compared to open surgery, however, the pressure used to create a PNP with sufficient surgical workspace still leads to significant tissue injury. Prior studies show that the use of low-pressure pneumoperitoneum (PNP) during laparoscopic surgery reduced postoperative pain scores, cumulative opioid consumption and improved bowel function recovery. Deep neuromuscular blockade (NMB) as compared to moderate NMB decreases the amount of intra-abdominal pressure required to achieve similar surgical conditions and enables the use of low-pressure PNP without compromising the quality of the surgical field and patient safety. Therefore, the use of deep NMB with low-pressure PNP could be a significant addition to the conventional Enhanced Recovery After Surgery (ERAS) protocols.
Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery 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
Total score on the Quality of Recovery-40 questionnaire
时间窗: 24 hours after surgery
The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200.
次要结局
- Intraoperative complications(During surgery)
- RAND-36 general health questionnaire(Upon admission and 3 months after surgery)
- Post-operative nausea and vomiting (PONV)(1, 8, 24 and 72 hours after surgery)
- Total score on the Quality of Recovery-40 questionnaire(Day 3 and day 7 after surgery)
- Cumulative use of analgesics and anti-emetics(1, 8, 24 and 72 hours after surgery)
- Length of hospital stay(From date of admission until date of discharge from the hospital (usually several days), assessed up to 3 months.)
- McGill pain Questionnaire(Upon admission and 3 months after surgery)
- Pain scores(1, 8, 24, and 72 hours after surgery)
- Surgical conditions(Intraoperative: after introduction of the trocars and every 15 minutes until the end of the pneumoperitoneum.)
- Time to reach discharge criteria(From date of surgery until date of actual discharge from the hospital (usually several days), assessed up to 3 months.)
- Postoperative complications(Up to 3 months after surgery)