Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Minimal intra-abdominal pressure
研究概览
简要总结
Optimizing all factors that increase the intra-abdominal volume and performing an individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15 mmHg).
详细描述
In the context of multimodal rehabilitation in colorectal laparoscopic surgery (Fast Track or ERAS (Enhance Recovery After Surgery)) multiple strategies have been introduced that have managed to improve patient recovery, decrease postoperative complications, decrease hospital days and decrease the overall costs per process.
The possibility of performing individualized colorectal laparoscopic surgery with the minimum insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and this would allow us to reduce the impact of surgery on the patient, decrease perioperative morbidity and improve patient recovery.
In our study, abdominal compliance, Pv0 and maximal Pv were determined during the initial performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of intra-abdominal pressure (IAP) insufflation was stablished with evaluation by the surgeons, until reaching the minimal insufflation IAP in which optimal surgical conditions are maintained.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Over 18 years of age
- •ASA I-III (American Society of Anesthesiologists physical status classification)
- •Signed informed consent
- •Absence of cognitive deficit
排除标准
- •Urgent surgery
- •Pregnancy or breastfeeding
- •Immune Disorder
- •Advanced renal, hepatic or cardiopulmonary disease
- •Negative to participate in the study
- •Under 18 years
- •Inability to give consent
- •Associated neuromuscular disorders
- •Allergy to rocuronium/sugammadex
- •Contraindication for use of rocuronium/sugammadex
结局指标
主要结局
Minimal intra-abdominal pressure
时间窗: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
To obtain values of intra-abdominal pressure level of minimum insufflation that guarantees optimal surgical conditions following an individualized strategy \[mmHg\].
次要结局
- Ventilation pattern pressure(From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.)
- Hospital stay(The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.)
- Intra-abdominal pressures (Pv0, maximal IAP)(From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.)
- Surgeon skills and experience(Years of experience, up to 10 years.)
- Intra-abdominal pressures (abdominal compliance).(From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.)
- Duration of surgery(The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes.)
- Postoperative complications(The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.)
研究者
Oscar Diaz-Cambronero
Physician, specialist in Anesthesiology
Hospital Universitario La Fe