Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food
研究概览
简要总结
The purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.
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
- Triple (Participant, Care Provider, Investigator)
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
- •All patients with postoperative ileus after colorectal surgery, defined as the presence from the third postoperative day, abdominal distension, nausea, vomiting with or without abdominal pain or discomfort by dilation of bowel loops, confirmed radiology of the abdomen, and which are: Age > 18 years Patients undergoing laparotomy or laparoscopy for the following variants of colorectal disease with or without stoma:
- •Inflammatory disease.
- •Diverticular disease. Patients who have been treated with standard PCA as postoperative analgesia. Signed informed consent. Undergoing elective or scheduled
排除标准
- •Patient's refusal to sign informed consent
- •Pregnancy or lactation
- •Hypersensitivity to iodinated contrast agents (it´s the only contraindication to oral Gastrografin) Presence of other problems that justify the etiology of postoperative ileus:
- •Anastomotic leakages.
- •Mesenteric vascular disease.
- •Incarcerated hernias.
- •Intra-abdominal abscesses or collections.
- •Metabolic or electrolyte disturbances. If during the course of the study one of the reasons previously cited as the etiology of postoperative ileus is present, the patient shall also be excluded. Also excluded patients undergoing emergency surgery.
研究组 & 干预措施
Gastrografin
Patients located in this group will be treated with the administration of 100 ml of gastrografin by the nasogastric tube, only once, after the diagnosis of postoperative ileus.
干预措施: Gastrografin (Drug)
physiological serum
Patients included in this group will be treated with 100 ml of physiological serum 0,9% by the nasogastric tube, only once, after the diagnosis of postoperative ileus.
干预措施: physiological serum (Drug)
结局指标
主要结局
Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food
时间窗: While the patient is admitted to the hospital. An average of 11 days since the intervention.
次要结局
- Presence of postoperative pain and analgesic required(While the patient is admitted to the hospital. An average of 11 days since the intervention)
- Percentage of mortality during hospitalization.(While the patient is admitted to the hospital. An average of 11 days since the intervention)
- Hospital stay after diagnosis of ileus(While the patient is admitted to the hospital. An average of 11 days since the intervention.)
- Percentage of patients requiring total parenteral nutrition.(While the patient is admitted to the hospital. An average of 11 days since the intervention)
研究者
Sebastiano Biondo
Principal investigator
Hospital Universitari de Bellvitge