Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Hospitalisation stay measured in days
研究概览
简要总结
This study wants to address the question of whether or not oral alimentation should be begun early in patients following colorectal surgery compared to the classical diet which depends on reappearance of functional intestinal transit. Early oral alimentation following colorectal surgery may decrease hospitalisation stay duration.
详细描述
Following intestinal surgery, the classical protocol indicates the use of a naso-gastric tube and starvation more or less prolonged of the patient dependent of surgeon's view. Decision to feed the patient is based on gas and feces reappearance after surgery. However, prolonged starvation might be uncomfortable for the patient as well as increasing his hospitalization stay. Moreover, delayed feeding effect on anastomosis and wound healing is controversial and naso-gastric tube use is known to be uncomfortable and may generate secondary adverse events.
Some studies in opened surgery observed that early alimentation was beneficial against post-surgery mortality, infection risk and anastomosis dehiscence. In addition, early feeding seemed to decrease patient hospitalisation stay.
In order to conduct this study, patients having a colorectal surgery will be randomly attributed to the nil per os group, which is based on the reappearance of a functional intestinal transit, or to the experimental group, which will begin alimentation 12 hours after colorectal surgery.
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
- •Patient 18 years old or more
- •Class ASA (American Society of AnaesthesioIogy) I, II or III, +/- E
- •Patient willing to participate in the study
- •Patient who understands and accepts to sign the informed consent form
- •Patient who will undergo elective or urgent colic resection using laparoscopy or opened surgery defined in section B
- •Section B: patient must meet one of the following inclusion criterion:
- •segmental or total colorectal resection with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
- •ileal resection in continuity with total or a segment of the colon with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
- •Closing of a terminal or loop colostomy
排除标准
- •Class ASA IV or V patient
- •Documented problem of gastro-intestinal motility
- •Pregnancy
- •Any acute or recent (<10 days) septic event
- •Chemotherapy during the 4 weeks preceding surgery
- •Previous irradiation surrounding the planned anastomosis location
- •Small intestine iatrogenic transparietal laceration done during surgery
- •Small intestine synchrone resection without continuity with the colon
- •Intra-peritoneal chemotherapy administered during or following surgery
- •Presence of residual peritoneal carcinosis at the end of surgery
- •Colic surgery associated with another major intra-abdominal surgery
- •Creation of a colo-anal or ileo-anal anastomosis
- •Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery
- •Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery
结局指标
主要结局
Hospitalisation stay measured in days
次要结局
- Gastro-intestinal signs and symptoms
- Treatment of gastro-intestinal signs and symptoms
- Post-surgery complications