Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Mean cost evaluation
研究概览
简要总结
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.
The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors.
While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.
Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.
详细描述
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.
The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors. Multiple interests have been shown:
- Equivalent mortality and/or morbidity compared with standard hospitalizations
- Medical and psychological benefits
- Individualized and less invasive health care pathways, in favor of patient's autonomy
- Multidisciplinary approach and innovative care
- Heath care costs management (decrease of hospital length of stay, optimization of operating rooms).
Ambulatory colectomies feasibility is recognized since 2013-2014 in France (Dr. Gignoux, MD in Lyon and Dr. Chasserant, MD in Le Havre). These ambulatory procedures are implemented in few expert centers with significant experience (more than 100 patients in Le Havre and more than 85 patients in Lyon) but several human and organizational limitations slow this innovative care.
The risk of complications does not seem to be increased on condition of anticipate and provide a postoperative follow-up at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Male or female over 18 years old
- •Patient able to understand the objectives and risks related to the trial
- •Patient able to give written informed consent
- •Patient able to understand and accept the health care program
- •Isolated colonic lesion located on the colon or the upper rectum
- •Any neoplastic or non-neoplastic colonic pathology
- •Colonic surgery except resection without continuity interruption (e.g. low cecum resection, partial colectomy, suture for polyp)
- •Moderate and/or controlled comorbidities
- •No history of multiple laparotomies
- •No psychosocial distress
- •No living alone patient
- •Patient registered with the French social security
排除标准
- •Patient in exclusion period of another clinical study
- •Emergency surgical procedure
- •Type 1 diabetes
- •Presence of an uncontrolled preoperative anemia
- •Effective anticoagulation treatment, impossible to suspend
- •Kidney failure (treated by dialysis)
- •Hepatic cirrhosis
- •Patient refusal
- •Patient in custody
- •Patient under guardianship
- •Pregnancy
- •Breastfeeding
- •Poor general condition
结局指标
主要结局
Mean cost evaluation
时间窗: 1 month
Mean cost evaluation, for the hospital, of the ambulatory care compared with standard hospitalization for patients who benefit from the ERAS program.
次要结局
- Mean time period required for a postoperative complication care(2 years and 3 months)
- Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale(7 and 30 days)
- Ambulatory care failure rate(2 years and 3 months)
- Complications rate(30 days)
- Complications severity classification(30 days)
- Mean hospital length of stay(2 years and 3 months)
- Ambulatory colectomies rate(2 years and 3 months)
- Hospital re-admissions rate(30 days)
- Rate of complications (Morbidity)(30 days)
- Rate of death (Mortality)(30 days)
- Evaluation of complication severity according to Clavien classification(2 years and 3 months)
- Costs related to postoperative complications(2 years and 3 months)
- Duty desk call(2 years and 3 months)
- Mean additional hospital length of stay(2 years and 3 months)
- Costs related to the management of postoperative complications(2 years and 3 months)