Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse II)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Change in Postoperative Quality of Recovery Scale (PQRS) Physiologic Domain
研究概览
简要总结
The purpose of this study is to assess the post-operative recovery quality of the Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery of their stay in the Post-Anaesthesia Recovery Unit.
详细描述
In the last two decades laparoscopic surgery has settled as a less invasive surgical approach compared to open surgery. It is associated with lower perioperative morbidity and hospital stay. There is growing evidence that increased intra-abdominal pressure (IAP), even for short periods of time, is associated with increased perioperative morbidity (pain, increased inflammatory markers peritoneal injury worse splanchnic perfusion abnormalities hemodynamic and ventilatory ...).
The study is a prospective multicenter randomized clinical intervention trial to assess the impact of IAP individualization strategy (IPP-Individualized pneumoperitoneum Pressure) relative to a IAP standard strategy (SPP-Standard pneumoperitoneum Pressure) using a validated scale (VAS) (PQRS- Postoperative Quality of Recovery Scale). Postoperative pain in the first 24 hours (area under VAS curve , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/lymphocyte, ratio,C-reactive protein, interleukin-6, procalcitonin) are also measured. Postoperative complications are evaluated by Clavier-Dindo classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients older than 18 years
- •Classification of the American Society of Anesthesiologists (ASA I-III)
- •No cognitive deficits
- •Signed informed consent prior to surgery
排除标准
- •Emergency surgery
- •Pregnancy or lactation
- •Immune disorders
- •Kidney or liver disease or advanced-stage cardiopulmonary
- •Patient refusal to participate in the study
- •Patients under 18 years or inability to consent
- •Associated neuromuscular disorders, contraindication for the use of rocuronium/ sugammadex, allergy or hypersensitivity to rocuronium / sugammadex
结局指标
主要结局
Change in Postoperative Quality of Recovery Scale (PQRS) Physiologic Domain
时间窗: Up to postoperative day 3. This is a longitudinal outcome.
The primary outcome of the IPPCollapse II study is the recovery of the Physiologic' component of the PQRS score over the assessed time points. The PQRS is a validated multidimensional patient Reported Outcome (PRO) tool designed to assess patients' recovery to baseline status in the postoperative period (www.postopqrs.com). In every patient a baseline measurement of PQRS is performed prior to surgery. After surgery, the measurement of the PQRS is repeated at 15 min (T15) and at 40 min (T40) after arrival in the PACU, as well as in the ward on the morning of postoperative day ( POD) one and three. Physiologic domain includes 9 variables scored from 1-3, 9 is the minimum and worse recover and 27 is the maximum and full recover. But recovery is related to baseline. Each patient is scored at the predefined time points and is classified as either 'recovered' if the score reaches at least the predetermined baseline score or 'not recovered' .
次要结局
- Spontaneous / coughing movements .(Up to 300 minutes during surgical intervention)
- Daily postoperative complications until hospital discharge (Clavien-Dindo)(Up to postoperative day 28)
- Basic features of airway pressures (plateauP, peakP, pulmonary Compliance)(Up to 300 minutes during surgical intervention)
- Intraabdominal volume(Up to 300 minutes during surgical intervention)
- Substudy- Hepatic perfusion during pneumoperitoneum.Plasma disappearance rate of indocyanine green (PDRICG)(Up to 300 minutes during surgical intervention)
- Chnge Postoperative Quality of Recovery Scale (PQRS)(Up to postoperative day 3. This is a longitudinal outcome.)
- Intraabdominal pressure(Up to 300 minutes during surgical intervention)
- Change in Surgical stress and inflammatory markers(Up to postoperative day 3. This is a longitudinal outcome)