Preoperative Oral Carbohydrate-rich Solution in Colorectal Cancer Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in HOMA-IR levels
研究概览
简要总结
Elective colectomy procedures typically require bowel preparation starting 2 days prior to the surgery. Osmotic laxatives such as Colyte® are administered 2 days prior, and Nothing by mouth (NPO) is required 1 day prior to ensure no fecal residue is left in the bowel. Though it may ensure a cleaner and safer surgery, this longer period of starvation increases insulin resistance and may increase post-op complications. However, there is evidence that administration of oral rehydration solution(ORS) prior to surgery reduces insulin resistance. Our purpose is to evaluate the difference of insulin resistance in those who received ORS 1 day prior to surgery and those who did not.
详细描述
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Enhanced Recovery After Surgery (ERAS) Enhanced Recovery After Surgery(ERAS) was introduced in the early 2000s by Kehlet et.al., and was applied primarily to patients receiving colectomy. As the knowledge and understanding of this concept continues to grow, we are now able to change the way we treat pre- and post- operative patients. In Europe, it has been proven that applying this concept to patients resulted in decreased length of post-operative hospital stay, post-op complications and overall hospital costs.
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The change in HOMA-IR with shorter preoperative Nothing by mouth (NPO) period in ERAS patients
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HOMA-IR Index equation (evaluation of Insulin resistance)
= Insulin (μU/ml) X blood glucose (mg/dl) / 405 2. HOMA-IR was statistically proven to have been lowered in patients who received ORS 2hr prior to surgery. 3. Reference
- Increased insulin resistance induces hyperglycemia
- Toxicity of post-op hyperglycemia and their relation to post-op complications
- Insulin resistance increases in procedures such as herniorrhaphy or laparoscopic cholecystectomy. Administration of preoperative carbohydrates decrease post-op nausea and vomiting
- Conventional pre-op 8hr fasting increases insulin resistance and influences increased glucose levels
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Additional benefits of shorter preoperative fasting
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Relieve of stress of fasting
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Help stabilize post-op triglyceride, cortisol, and glucose levels
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Reduce infectious complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA grade I~II (DM, CVA, COPD, ESRD, MI, TIA etc. excluded)
- •Age: adults age 19~75
- •Patients undergoing elective colon cancer surgery
- •Able to take the ORS per orally. Able to swallow without trouble of aspiration tendencies
- •BMI of less than 27.5
- •Child-Turcotte-Pugh Classification score of less than 6
排除标准
- •emergency cases such as obstruction or perforation
- •food allergy
- •abdominal distension at present
- •prior gastric surgery
结局指标
主要结局
Changes in HOMA-IR levels
时间窗: 6hr, 24hr, 48hr
HOMA-IR = Insulin (μU/ml) X blood glucose (mg/dl) / 405 insulin and glucose levels are obtained 6hrs, 24hrs, 48hrs post-op Derive the value using the obtained sample variables into the HOMA-IR equation and comparison using statistical analytic methods
次要结局
- Changes in triglyceride level(0hr (induction of general anesthesia), 24hr)
- Changes in Insulin levels(0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr)
- Changes in cortisol level(0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr)
- Reduction of postoperative complications(Participants will be evaluated daily till discharge, an expected average of 6 days)
- Assessment of patient pain via Visual Analogue Scale(Participants will be evaluated daily till discharge, an expected average of 6 days)
- Changes in glucose level(0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr)
研究者
Sung-Bum Kang
Associate Professor
Seoul National University Bundang Hospital