Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Recovery of gastrointestinal function
研究概览
简要总结
For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate improves postoperative recovery. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.
详细描述
Studies show that avoiding long-time fasting by oral carbohydrates 2 hours before surgery attenuates discomfort and anxiety; it also reduces stress, insulin resistance and catabolism in patients undergoing gastrointestinal surgery, resulting in earlier recovery of gastrointestinal function and short length of hospital stay after surgery. However, for diabetic patients scheduled to undergo gastrointestinal surgery, the risks and benefits of preopertive oral carbohydrate remain unclear. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.
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)
盲法说明
Outcomes assessor who perform postoperative follow-up is masked to group assignment.
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
- •Age of 18 years and beyond;
- •Diagnosed with type 2 diabetes before surgery;
- •Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more;
- •Provide signed writen informed consents.
排除标准
- •Refuse to participate in the study;
- •Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
- •Previous history of total or partial gastrectomy;
- •Preoperative New York Heart Assocition (NYHA) class IV, renal failure (requirement of renal replacement therapy), severe hepatic disease (Child-Pugh class C), or American Society of Anesthesiologists (ASA) class IV or higher;
- •Preoperative pyloric and/or intestinal obstruction;
- •Combined surgery on other intra-abdominal organs or other parts of the body.
研究组 & 干预措施
Intervention group
For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking.
For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking.
干预措施: Oral carbohydrate (Outfast) (Dietary Supplement)
Control group
For all patients, routine fasting (drinking water allowed) begins from 22:00 on the day before surgery， water fasting begins from 6:00 on the day of surgery.
For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided from 6:00. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, magnesium sulfate) are added when becessary.
干预措施: Routine fasting (Other)
结局指标
主要结局
Recovery of gastrointestinal function
时间窗: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.
Time to first flatus and defecation after surgery.
次要结局
- Blood glucose variation(From 22:00 on the day before surgery until 24 hours after surgery.)
- Subjective feelings(Before anesthesia induction and at 4-6 hours after surgery.)
- Insulin resistance (in part of patients)(Assessed at 24 hours after surgery.)
- Incidence of postoperative complications(From end of surgery until 30 days after surgery)
- Time to first walking in the ground and distance of walking after surgery.(During the first 5 days after surgery)
- Length of stay in hospital after surgery.(From end of surgery until hospital discharge, up to 30 days after surgery.)
- All cause 30-day mortality(At 30 days after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital