The Protective Role of Preoperative Stimulation of the Distal Limb of the Ileostomy Loop With GABA Before Ileostomy Closure
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- incidence of complications after ileostomy closure
研究概览
简要总结
The goal of this clinical trial is to explore whether preoperative stimulation of the distal limb of the ileostomy loop with gamma aminobutyric acid (GABA) could effectively reduce the incidence of complications after ileostomy closure.
Participants will be divided into two groups. One group included patients treated with stimulation of the efferent loop with GABA prior to transit reconstruction surgery; the other control group was stimulated without giving any substance.
Researchers will compare incidence of complications such as postoperative ileus, diarrhea and other parameters such as time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay, etc.
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 (Participant)
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
- •over 18 years of age;
- •body mass index (BMI) 18.5-28 kg/m2;
- •having protective ileostomy after colorectal carcinoma surgery free of disease;
- •with endoscopic and histological confirmation of diversion colitis;
- •no oral antibiotics within 3 months;
- •having signed the informed consent.
排除标准
- •under 18 years of age;
- •clinical history, and histological confirmation of inflammatory bowel disease with colorectal involvement;
- •history of neoadjuvant or adjuvant chemoradiotherapy;
- •other serious chronic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, etc;
- •serious perioperative complications such as anastomotic rupture after surgery;
- •oral antibiotics within three months;
- •participation in any other studies within the past 3 months.
研究组 & 干预措施
preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery
Preoperative stimulation of the distal limb of the ileostomy loop with GABA was performed during the 5 days prior to surgery every day. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool. Sterile Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline. Each preparation was made under sterile conditions and maintaining the cold chain.
干预措施: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery (Dietary Supplement)
control group was stimulated without giving any substance
Control group was stimulated without giving any substance. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool.
After 5 stimulation sessions, reconstructive surgery was performed within the following 24 h.
干预措施: preoperative stimulation of the efferent loop with only physiological saline (Dietary Supplement)
结局指标
主要结局
incidence of complications after ileostomy closure
时间窗: From date of randomization until the date of discharge, assessed up to 20 days
postoperative ileus, diarrhea, time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay.
次要结局
- glucose metabolism-related parameters(From date of randomization until the date of discharge, assessed up to 20 days)
- metabolite alteration(From date of randomization until the date of discharge, assessed up to 20 days)
- microbiota alteration(From date of randomization until the date of discharge, assessed up to 20 days)
研究者
Wei Guo
associate professor
Qilu Hospital of Shandong University