Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain
研究概览
详细说明
Post-operative ileus is a common surgical complication occurring in with up to 20% of patients, with a significant clinical and economical effect.
Many preventative measures have been tested to promote gastrointestinal motility following intestinal surgery have been suggested.
The medical intervention in the proposed study includes administration of a selective COX-2 inhibitor, specifically Celecoxib, in the peri-operative period following an elective colon resection. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic therapeutic effects.
The drug is approved for use in by the ministry of health in Israel and in the United states. The study aims to assess the use of this widely used medication for evaluation of the clinical effect on post-operative bowel transit, as well as the drugs' effect on post-operative pain.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
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:
- Patients between the age of 18 and 80
- Patients planned for elective colorectal surgery with primary anastomosis
- ASA score of 1-3
- Patients that are able to sign an informed consent and comply with the protocol
Exclusion Criteria:
- Patients with inflammatory bowel disease
- Patients that require emergency surgery
- Patients with renal failure, measured by Creatinine level > 1.5 mg/dL (>106.1 micro mol/l)
- Patients with significant liver failure (known cirrhosis, Bilirubin level>2 mg/dL or 34.2 µmol/L)
- Patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group.
- Patients treated chronically with any type of COX inhibitor.
- Patients treated with NSAIDS including Aspirin 7 days prior to the date of surgery.
- Patients with active peptic disease
- Patient expected to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics or neuroleptics in the postoperative period
- Patient with dysphagia or that have a difficulty swallowing capsules or tablets, or is unable to tolerate oral medication
- Pregnant / lactating women.
- Patients participating in any other interventional clinical trial
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Celecoxib
Celecoxib will be given orally to patients participating in the study and allocated to the treatment group, for an intervention period of 6 days, starting from the day of surgery. Celecoxib will be given throughout the intervention period of the study orally at a dose of 400 mg per day divided into two doses, a dose which is within the recommended and a widely used dosage and is expected to induce a significant inhibition of prostaglandin synthesis by the COX2 pathway. Celecoxib will be given throughout the intervention period of the study orally at a dose of 400 mg per day divided into two doses. |
NSAIDS
|
|
安慰剂比较：Placebo
Placebo will be given orally to patients participating in the study and allocated to the control group that will receive placebo, for an intervention period of 6 days, starting from the day of surgery. Placebo will be given throughout the intervention period of the study orally in capsules that resemble the drug, twice a day. |
安慰剂
|
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 |
|---|---|---|
|
First flatus/bowel movement (questionnaire)
大体时间：48 to 72 hours after surgery
|
Reduction of time for first flatus/bowel movement from 48 hours to 72 hours in average following surgery.
|
48 to 72 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction of post operative ileus (questionnaire)
大体时间：First week after surgery
|
Reduction of post-operative ileus rate in patients following colorectal surgery, treated with Celecoxib when compared with patients treated with placebo.
|
First week after surgery
|
|
Post operative pain reduction (VAS score)
大体时间：First week after surgery
|
Post-operative pain reduction quality in patients treated with Celecoxib when compared with patients treated with placebo following surgery.
|
First week after surgery
|
|
Reduction of opoids consumption (registration of all medications)
大体时间：First month after surgery
|
Reduction the amount of opioids consumed in patients treated with Celecoxib when compared with patients treated with placebo following surgery.
|
First month after surgery
|
|
Post operative complication rate (patients follow up)
大体时间：First month after surgery
|
Post-operative complication rate, more specifically the rate of anastomotic leakage in patients treated with Celecoxib compared with patients treated with placebo.
|
First month after surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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