Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)
试验速览
- 阶段
- 不适用
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- The frequency of complications occurring in patients with a temporary high-output double enterostomy.
研究概览
简要总结
In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Aged over 18 years
- •Temporary high-output double enterostomy (≥1500ml/24 hours)
- •Total small bowel length ≥ 120 cm
- •Downstream small bowel consisting of at least 25 cm of healthy bowel, accessible by a stoma, and suitable for chyme reinfusion
- •Oral feeding resumed for at least 5 days
- •Parenteral nutrition or hydration required until the surgical reestablishment of digestive continuity
- •Affiliation to an health insurance (general Social Security scheme or an equivalent scheme)
- •No current or planned participation in another biomedical research
- •Signature of an informed consent form
排除标准
- •Expected duration of parenteral nutrition or chyme reinfusion less than 2 weeks
- •Refusal by the patient to have a mixed texture diet,
- •Chemotherapy or radiotherapy before the surgical reestablishment of digestive continuity,
- •Not drained intra-abdominal collection,
- •Fever, uncontrolled infection, or infection treated for less than 72 hours,
- •Shock of any cause,
- •Creatinine clearance ≤ 60 ml/min
- •Patients under guardianship.
研究组 & 干预措施
parenteral nutrition
Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.
干预措施: parenteral nutrition (Drug)
chyme reinfusion
Chyme reinfusion consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump.
干预措施: Entéromate™ (Device)
结局指标
主要结局
The frequency of complications occurring in patients with a temporary high-output double enterostomy.
时间窗: From the day which the patient no longer requires surgical care after the surgical placement of a temporary double enterostomy (Day 0) and up to 30 days after the reestablishment of digestive continuity (Month 4 (minus) - Month 9 (plus))
The reestablishment of digestive continuity is possible between Month 3 and Month 8 (it is patient-dependent) The complications, and their severity, will be classed using the Dindo-Clavien classification.
次要结局
未报告次要终点