Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 168
- 试验地点
- 4
- 主要终点
- Total length of hospital stay
研究概览
简要总结
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.
详细描述
Rationale :
Loop ileostomy is defined by bringing a loop of small bowel out onto the surface of the skin to allow diversion of the fecal stream. It is a common procedure that is conjointly done with colorectal surgeries with the objective to protect intestinal anastomosis at high risk of leaking. Loop ileostomy closure is then performed in the months following the initial surgery when the anastomosis has healed. Often thought of as a simple procedure, it is still associated with a significant postoperative morbidity rate consisting mostly of postoperative ileus. In the CHU de Québec-Université Laval, patients are hospitalized for a median of five days until their bowels open up while no active care is given. This represents 645 days of hospitalization each year for Hôpital Saint-François d'Assise (HSFA), Hôtel-Dieu de Québec (HDQ) and Centre Hospitalier de l'Université Laval (CHUL). Hence, there is a clear need to determine if the investigator can improve the outcomes following ileostomy closure by applying a standardized enhanced recovery pathway specific to ileostomy closure to the point where the surgery can be performed in a twenty-three hours hospitalization setting.
Objective :
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.
Hypothesis :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Aged 18 years and older
- •Able to provide informed consent
- •ASA I and II (American Society of Anesthesiologists)
- •Staying less than 50 kilometers from a hospital after surgery
- •Being accompanied by an adult able to assist the patient in his recovery and to intervene in case of an emergency for the first 48 hours after surgery
- •No anastomotic leak proven on preoperative water soluble enema
排除标准
- •Language barrier or significant communication problem
- •Immunosuppression
- •Therapeutic anticoagulation
- •Previous proctocolectomy
- •Previous ileal pouch anal anastomosis
- •Technical factors during surgery (conversion to midline laparotomy or other, at surgeon's discretion)
研究组 & 干预措施
Intervention group (23-hour stay)
Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
干预措施: Early discharge from hospital (Other)
Control group (conventional hospitalization)
Patients randomized to the group conventional hospitalization will be hospitalized as per the current conventional care after ileostomy closure.
结局指标
主要结局
Total length of hospital stay
时间窗: 30 days after surgery
The number of days spent in the hospital from the time of the surgery to the time of the discharge as well as any day spent in the hospital after any readmission in the 30 days following the ileostomy closure.
次要结局
- Postoperative ileus rate(30 days after surgery)
- Postoperative complication rate(30 days after surgery)
- Postoperative mortality rate(30 days after surgery)
- Readmission rate(30 days after surgery)
- Postoperative surgical site infection rate(30 days after surgery)