Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Tolerating Low Residue Diet
研究概览
简要总结
Postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients. Stomas are frequently created in conjunction with major colorectal surgery. Obstruction at the level of the stoma is a common cause of bowel obstruction or ileus. This is often manifested by decrease or delay in stoma output and is often attributed to edema at the level of the stoma. Thus, a temporary tube (red robinson catheter) is placed into the stoma at bedside, which often relieves the obstruction until the edema at the level of the stoma resolves and stoma function occurs around the temporary tube. At this time, the tube is removed and the stoma continues to function normally.
The purpose of this study is to evaluate whether a stoma tube (red-robinson catheter) placed at the time of stoma creation would reduce the incidence of postoperative ileus in patients undergoing major colorectal surgery with creation of a stoma.
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
- •Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- •Males or females, 18> years of age and older inclusive at the time of study screening;
- •American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
- •Due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy;
排除标准
- •Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
- •American Society of Anesthesiologists (ASA) Class IV or V;
- •Children <18 years
研究组 & 干预措施
Stoma tube
Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
干预措施: Stoma Tube (Device)
Standard Stoma
Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postoperative if the patient is felt to have postoperative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
结局指标
主要结局
Tolerating Low Residue Diet
时间窗: by postoperative day 3( 3rd day after surgery)
% of patients tolerating a low residue diet on postoperative day 3 will be assessed
次要结局
- Time to Flatus (Passing Gas Into Stoma Bag)(during 30 day postoperative period)
- Time to Passage of Stool(during 30 day postoperative period)
- Hospital Discharge(30 day postoperative period)
- Time to Discharge Based on GI Function(30 day postoperative period)
- Major and Minor Medical and Surgical Complications(30 day postoperative period)
- Any Insertion of Nasogastric Tube(30 day postoperative period)
- Episodes of Vomiting(during postoperative hospital admission (30 day period))
- Diagnosis of Postoperative Ileus(30 day postoperative period)
研究者
Phillip Fleshner MD
Director of Colorectal Surgery Residency
Cedars-Sinai Medical Center