Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Ileus
研究概览
简要总结
The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage. I t is most often performed after a low anterior resection indicated for lower-middle rectal cancer. A second operation is required for closure, with a morbidity of about 25%.
Many studies have been completed in order to detect possible risk factors - both patient-related and surgery-related - for complications in ileostomy closure surgery. Currently, there is a lack of research studies focused on the preoperative management of these patients.
Our purpose is to reduce the complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus.
Main objective: To assess whether efferent loop stimulation two weeks before ileostomy closure decreases the incidence of postoperative paralytic ileus.
详细描述
The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage. I t is most often performed after a low anterior resection indicated for lower-middle rectal cancer. A second operation is required for closure, with a morbidity of about 25%. Bowel obstruction is the most common complication following this procedure, with an incidence of up to 29%. There is also a risk of anastomotic leakage, observed in 2% of patients, with a reintervention rate approaching 10%. A recent meta-analysis reported up to 2% mortality after stoma reversal.
There are many structural changes in the mucosa of the small bowel after ileostomy formation, which may contribute to the observed morbidity. The distal end may be atrophied, with pathophysiological changes contributing to a reduction in absorptive function and motility.
CONTROVERSY Many studies have been completed in order to detect possible risk factors - both patient-related and surgery-related - for complications in ileostomy closure surgery. Currently, there is a lack of research studies focused on the preoperative management of these patients.
THE NEED FOR SUCH A STUDY There is a high risk of complications following ileostomy reversal (as high as 20%), including bowel dysfunction, anastomotic leakage, bowel perforation and postoperative ileus. This increases the length of hospital stay and healthcare costs.
Our purpose is to reduce this complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients over 18 years of age who undergo a scheduled protective ileostomy closure surgery, performed in rectal cancer surgery. All patients will follow a homogeneous protocol for testing the rectal anastomosis prior to closure, based on an opaque enema to rule out the presence of anastomotic leakage. Entry into the study does not affect the other surgical indications, in terms of time to ileostomy closure, type of operation or anaesthesia, or request for additional tests. Elective surgery. Patients who sign the informed consent document.
排除标准
- •Patients undergoing simultaneous abdominal procedures at the time of ileostomy closure. History of protective ileostomy for a pathology other than rectal cancer. History of surgery in the ileal region.
结局指标
主要结局
Ileus
时间窗: 1 month
Presence of paralytic ileus (defined as intolerance to oral food on or after the third postoperative day, in the absence of clinical or radiological signs of obstruction, requiring placement of a nasogastric tube or associated with two of the following: nausea/vomiting, abdominal distention and the absence of flatus).
次要结局
- Time to tolerate regular diet(1 month)
- Hospital stay(1 month)
- Time to first passage of flatus(1 month)
- Time to first passage of stool(1 month)
- General morbidity(6 months)
- Postoperative continence(6 months)
- Hospital readmission(6 months)
研究者
Dr. Jorge Arredondo
MD PhD
Universidad de León