Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance due to surgical stress.
The aim of this study is to investigate whether preoperative oral carbohydrate loading can contribute to lower incidence of postoperative discomfort and to reduce complications in elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).
研究概览
详细说明
Fasting from 6-12hours before elective surgery is still standard of care in many departements, including our departement in Oslo University Hospital.
Surgery is a trauma that triggers a catabolic stress response with high emissions of hormones and immune activation. These activations can affect brain, heart, muscles and liver. The metabolic changes may in addition influence development of pain, tissue damage, ileus, tachycardia and other hemodynamic disturbances. Preoperative fasting has shown an increase of surgical stress and to impact catabolic processes which secondarily may lead to insulin resistance and hyperglycemia in non-diabetic patients. Insulin resistance and hyperglycaemia are known to increase the incidence of postoperative infections. Previous studies have also shown that prolonged fasting increases the incidence of gastrointestinal problems. A 12 hour fast before surgery has shown delayed recovery.
Studies have shown that patients undergoing lung cancer surgery suffer from multiple symptoms and experience discomfort in the postoperative phase. Symptoms include dyspnea, fatigue, pain, weakness, cough, dry mouth, nervousness, difficulty sleeping, stomach-/intestinal-problems and lack of appetite. Carbohydrate-rich supplements have shown a positive effect on other perioperative symptoms and measures, but is to our knowledge currently not investigated in lung cancer surgery.
Therefore, there is a need to explore the possible advantages of preoperative oral carbohydrate loading in lung cancer surgery.
The primary aim of this study is to investigate whether preoperative carbohydrate loading with PreOp® provides less postoperative discomfort in the early postoperative phase measured by Quality of Recovery-40 (QoR-40), a validated and widely used measure of quality of recovery.
The secondary aim is to investigate if preoperative loading with carbohydrates affect the incidence of postoperative complications such as stomach-/intestinal problems and heart rhythm disorder, in addition to contribute to faster mobilization and to reduce hospital length of stay.
This study may provide important data regarding the lung cancer patients perioperative symptoms, complications and well-being when using a carbohydrate-rich supplement as intervention to standard of care.
In this study, the intervention group will be given 800ml of a oral carbohydrate supplement, PreOp®, the night before surgery and 400ml of the same supplement, PreOp®, 2-4 hours prior to surgery. The control group will be fasted from 24h, the night before surgery, in accordance to the departements standard of care.
Both groups, the interventional and the control group, will follow the department's perioperative course with regard to anesthetic and surgical procedures.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Oslo、挪威、0450
- 招聘中
- Oslo University Hospital
-
接触:
- Per Reidar Woldbaek, MD, PhD
- 电话号码:+4798895427
- 邮箱:uxpewo@ous-hf.no
-
接触:
- Astrid Krohn-Hansen, RN
- 电话号码:+4792270669
- 邮箱:astkro@ous-hf.no
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
adult patients undergoing elective video-assisted thoracoscopic surgery due to lung neoplasms.
- ability to understand and speak Norwegian
Exclusion Criteria:
- impaired gastric emptying
- diabetes
- ongoing treatment for pain
- ongoing infection
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Interventional group
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
|
No preoperative drink.
其他名称:
|
|
无干预:Control group
Standard of care: Fasting from 24hours (midnight), night before surgery.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
大体时间:First postoperative day
|
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
|
First postoperative day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gastrointestinal discomfort postoperatively.
大体时间:First seven postoperative days.
|
Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.
|
First seven postoperative days.
|
|
Heart rhythm disturbances postoperatively.
大体时间:First seven postoperative days.
|
Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.
|
First seven postoperative days.
|
|
Time to mobilization.
大体时间:First seven postoperative days.
|
Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.
|
First seven postoperative days.
|
|
Length of stay
大体时间:First seven postoperative days.
|
Length of hospital stay to discharge for index admission.
|
First seven postoperative days.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.