Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- To assess the impact of the stable low-pressure approach (using Airseal Insufflator) and its associated parameters into the the early rehabilitation program after colorectal surgery on length of stay.
研究概览
简要总结
The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.
详细描述
Laparoscopy is currently the gold standard for the vast majority of abdominal surgeries, and especially for colectomy for cancer or benign diseases. There are many data showing the benefits of the laparoscopic approach to colectomy in terms of morbidity, post-operative pain and analgesic consumption, length of hospital stay, cosmetic results, and improved patient satisfaction. In 2002, consensus European guidelines recommended insufflating at the lowest pressure that still provides sufficient exposure. Considering these results, low-pressure laparoscopy is one of the alternatives that have been developed to do away with the complications of the pneumoperitoneum while retaining its advantages.
However, other factors may influence the outcomes of the low-pressure pneumoperitoneum such as the use of humidification and warming gaz, robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall, ventilation-induced changes, and probably individual patient factors like obesity. These parameters could not be separately tested in randomized trial. We should consider all these parameters in a prospective international registry in order to optimize the benefit of low-pressure pneumoperitoneum in post-operative recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years old
- •Colonic resection (right or left, subtotal or total) performed for benign or malignant pathology
- •Rectal resection with or without stoma for benign or malignant pathology
- •Laparoscopic or robotic procedure
- •Surgery under low stable pressure pneumoperitoneum with AirSeal
- •Patient who benefits by medicare system
- •Oral agreement after reading information letter
排除标准
- •Laparotomy procedure
- •Associated resection (except appendectomy or liver biopsy)
- •Transverse colectomy
- •Emergency procedure
- •Pelvic sepsis
- •Pregnancy or breast feeding period
- •Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
- •Persons deprived of liberty or under guardianship
结局指标
主要结局
To assess the impact of the stable low-pressure approach (using Airseal Insufflator) and its associated parameters into the the early rehabilitation program after colorectal surgery on length of stay.
时间窗: From the surgery to the end of the hospitalization (max 30 days)
Evaluate the Length of hospital stay after colorectal surgery.
次要结局
- The impact of the anesthetic management on the feasibility and benefit of low stable pressure(From the surgery to the end of the hospitalization (max 30 days))
- The impact of stable low pressure on the postoperative pain after colorectal surgery(At 24 hours after the end of the surgery)
- The Post-operative Surgical and Medical morbidity(From the surgery to the end of the hospitalization (max 30 days))
- The impact of stable low pressure on the opioid consumption after colorectal surgery(From the surgery to the end of the hospitalization (max 30 days))
- The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure(From the surgery to the end of the hospitalization (max 30 days))
- The Surgical and Medical morbidity at 30 days(At 30 days after the end of the surgery)