Evaluation of Microporous Polysaccharide Hemospheres (MPH) Agent in Preventing Postoperative Complications After Rectal Surgery (EPHAS Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- postoperative pelvic sepsis including anastomotic leakage, pelvic abscess and peritonitis.
研究概览
简要总结
Multi-center, prospective, cohort study, of patients scheduled for elective rectal surgery who received absorbable hemostatic powder to assess whether it can improve patient postoperative outcomes, reduce usage of drains and prove to be cost-effective. This cohort will be compared to a previously studied cohort using drains (Power and IMPRICA study) with comparable patient characteristics.
The primary endpoint of the study is: postoperative pelvic sepsis within 60 postoperative days including anastomotic leakage, pelvic abscess and peritonitis.
Secondary endpoints: postoperative morbidities, rate of reoperation and length of hospitalization.
详细描述
Multimodal surgical rehabilitation, also known as Enhanced Recovery After Surgery, entails the application of a series of perioperative procedure measures and strategies aimed at patients who are going to undergo a surgical procedure with the objective of reducing secondary stress caused by the surgical intervention and thus achieve enhanced recovery of the patient and decrease complications and mortality.
ERAS protocols are care programs based on scientific evidence, encompassing all aspects of patient care and requiring multidisciplinary management, with the participation of diverse specialists1. Starting at the diagnosis, their aim is to recognize patients' individual needs to optimize their treatment before, during and after surgery. The close collaboration of all specialists participating in the process, as well as of the actual patients and their relatives has proved to be essential.
The Multimodal Rehabilitation Programmes (MRP) or Enhanced Recovery Programmes (ERAS) review traditional perioperative procedure practices, evaluating the specific key points of each type of surgery and analysing their scientific evidence. MRPs have shown, in cents that have routinely adopted them, a significant improvement in the patient's quality of life. Furthermore, MRPs significantly reducing the hospital stay and potential complications associated with hospitalisation2, being the anastomotic leak (AL) the most serious of them.
Total mesorectal excision (TME) and bowel restoration is currently the standard treatment for middle to low rectal cancer. However, TME has been shown to be associated with high anastomotic leakage with a reported incidence of up to 24%, reaching 50% when clinically silent radiographic leaks are considered3.
Despite a large number of studies in the literature that have investigated risk factors, the fundamental causes of AL remain unclear. In this sense, according to enhanced recovery after surgery (ERAS) protocols4, pelvic drain should not be used routinely as it may cause patient discomfort and prolong hospitalization. Moreover, drain itself is also a potential site of infection especially if open or passive drainage system is used.
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
- •All adult patients (aged >18 years) with a diagnosis of malignant rectal cancer who are scheduled for radical surgery (anterior resection). Informed consent will be obtained from all subjects, who will participate in the study voluntarily.
排除标准
- •Patient refusal, patients undergoing emergency surgery, patients under 18 years of age, existence of other concomitant surgical processes. Previous chemo-radiotherapy. Ileostomy or colostomy. Patients that have receive a drain.
结局指标
主要结局
postoperative pelvic sepsis including anastomotic leakage, pelvic abscess and peritonitis.
时间窗: 60 days
% patients with organ-space infection or anastomotic leak
次要结局
- rate of reoperation(60 days)
- Hospital stay(60 days)
- postoperative morbidities(60 days)