Outpatient Management of Patients With a Left Laparoscopic Colectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 30-day readmission rate
研究概览
简要总结
The success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. To this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. The objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.
详细描述
In France, colectomy represents about 40,000 interventions per year, most of them scheduled, and 2/3 in a context of neoplasia. This surgery is associated with numerous postoperative complications. Since the start of Enhanced Recovery After Surgery (ERAS) in 1997, complications have been steadily reduced by optimizing surgical and anaesthetic techniques. At the same time, the average length of post-operative stay has decreased. In 2014, ERAS was the subject of recommendations by the French Society of Anaesthesia and Resuscitation, taken up by the French Health Authority (HAS) in 2016, and which are now an integral part of surgical management in colorectal surgery. More recently, two teams have set up an outpatient colectomy program. The three studies published on this subject show encouraging results, in a private structure, with no increase in postoperative complications.
In accordance with the recommendations on ERAS published by the HAS, a program involving pre-, per- and post-interventional investment, has been put in place. Patients are discharged on D0, followed by close monitoring by a home care nurse twice daily. This nurse is in charge of collecting clinical data in order to detect possible early signs of post-operative complications that would justify re-hospitalisation after a medical-surgical decision.
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
- •American Society of Anesthesiologists Classification (ASA) score I and II,
- •Patient with an indication for scheduled left colectomy due to neoplastic (stage 1) or diverticulitis,
- •Patient residing less than 30 minutes from La Rochelle hospital,
- •Presence of a companion from the anaesthesia consultation onwards,
- •Presence of an attendant at the patient's discharge,
- •Perfect understanding of outpatient care, pathology and surgical procedure of the patient and accompanying person,
- •Informed of the study.
排除标准
- •ASA score 3 et 4,
- •Indication for a straight or transverse colectomy,
- •Neoplasia evolution > stage 1,
- •Presence of anticoagulant treatment,
- •Intraoperative bleeding > 500ml,
- •Conversion to laparotomy,
- •Severe anesthetic complication (Anaphylaxis, Difficult Intubation),
- •Persons deprived of their liberty by a judicial or administrative decision,
- •Persons of full age who are subject to a legal protection measure,
- •Persons unable to consent,
- •Persons who are not members of or beneficiaries of a social security scheme,
- •Patient's refusal to participate in the study.
结局指标
主要结局
30-day readmission rate
时间窗: 30 days after surgery
Number of re-hospitalisation after a medical-surgical decision due to post-operative complications
次要结局
- Pain measurement: pain rating scale(7 days after surgery)
- Mobilization(Day 0)
- Ileus(up to 7 days after surgery)