The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Anastomotic leakage rate between treatment arms
研究概览
简要总结
There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery. The available evidence is based on studies with methodological differences. Most of the studies exclude patients with a diverting ileostomy, which are those patients who have a higher risk of anastomotic leak, so the real effect of transanal decompressive tube could have been masked. For this reason we believe that to assess the true effect of rectal decompression, patients with diverting stoma should be included.
详细描述
One of the complications of performing the colorectal anastomosis is the anastomotic leak, which sometimes entails the need for reinterventions and stoma formation (provisional or definitive). In recent decades, the improvement in surgical techniques together with the knowledge of the causes that predispose to the anastomotic failure have allowed to reduced the rates.
The placement of a tube probe through the anus in the postoperative period that decompresses the contents of the interior of the intestine (liquid or air) has been proposed as a factor that could influence the healing between intestines.
In studies carried out in other centers, with the same characteristics as the present one, differences have been shown in the probability of anastomotic leakage, but these results are not conclusive and do not allow us to know the effectiveness of this procedure.
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
- Single (Outcomes Assessor)
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 undergoing scheduled laparoscopic, robotic or laparotomic colorectal cancer surgery who undergo colorectal anastomosis.
- •Both mechanical and manual colorectal anastomosis with or without diverting ileostomy.
- •Negative intraoperative air-leak test.
- •Height of the anastomosis: promontory or distal to it.
- •Age≥18 years.
- •Histology of Adenocarcinoma with or without prior neoadjuvant treatment.
- •Any T, any N, any M.
- •Informed consent signed by the patient and by the researcher.
排除标准
- •No performance of colorectal anastomosis.
- •Colorectal tumor with histology other than adenocarcinoma or adenoma.
- •Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of surgery.
- •Inability to read or understand any of the informed consent languages (Catalan, Spanish).
- •Emergency surgery.
- •Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
结局指标
主要结局
Anastomotic leakage rate between treatment arms
时间窗: Within 30 days after surgery
Anastomotic leakage (No/Yes), degree of anastomotic leakage (A, B or C), days of anastomotic leak diagnosis after colorectal surgery
次要结局
- Reintervention rate(Within 30 days after surgery)
- Postoperative complication rate(Within 30 days after surgery)
- Definitive and / or temporary stoma rate after anastomotic leakage(Within 30 days after surgery)
研究者
Ander Timoteo Delgado
General and digestive surgeon
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta