Effects on Omission of NSAIDs on the Consumption of Opioids in the Standard Analgesic Regimen After Elective Laparoscopic Colorectal Cancer Resection in an ERAS Setting. A Retrospective Single-center Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Postoperative opioid-consumption
研究概览
简要总结
Patients undergoing an operation for colorectal cancer are normally treated with non-steroid-anti-inflammatory-drugs (NSAIDs) e.g. ibuprofen as pain medication after the operation. It is well known that NSAIDs can be harmful to kidney-and heart patients and some studies also have shown an increased risc of surgical complications after treatment with NSAIDs. On the other hand recent studies have found a preventive effect of NSAIDs on colorectal cancer recurrence thus leaving the colorectal surgeon in doubt whether NSAIDs are beneficial or harmful to colorectal cancer patients.
In the department of colorectal cancer surgery at Zealand University Hospital it was decided to leave out NSAIDs from the 1st of april 2016. This study will investigate if there is a change in consumption of opioids before and after omission of NSAIDs. This will be an important finding because opioids also have harmful side-effects as well as a risk of addiction. The investigators will also compare the blood samples and see if there is signs of impaired renal and cardiac function in the group that was treated with NSAIDs. Finally the long term outcomes will be investigated such as cancer recurrence and death in the two groups.
详细描述
Background:
Many standard analgesic regimens after colorectal cancer surgery includes a NSAID in combination with paracetamol and other non-opioid analgesics. Concerns about a risk of cardiovascular and renal impairment and the possible association with anastomotic leaks have questioned the rationale of NSAID use in the postoperative period and the need for possible alternatives. In the department of colorectal cancer -surgery of Zealand University Hospital it was decided to remove NSAIDs from the standard analgesic package from 1th of April 2016 without other analgesic substitution. This change might imply deterioration of the enhanced recovery program with an increase in the use of opioids and side effects that might cause a longer length of stay. In addition, recent studies are relaunching ibuprofen as a chemo-preventive of colorectal cancer thus leaving the colorectal surgeon in doubt whether NSAIDs are beneficial or harmful to colorectal cancer patients.
Objective:
The aim of the present study is to investigate the short- and long-term outcomes before (+ ibuprofen) and after (- ibuprofen) April 1 st 2016.
Methods Design A prospective, consecutive single-center cohort-study. Study population Patients undergoing elective laparoscopic colorectal cancer resection at Zealand University Hospital, before and after 1st. of April 2016 are eligible for the study. Patients with a preoperative use of opioids within the last 3 months, undergoing a palliative resection or had a surgical complication leading to reoperation in general anesthesia will be excluded. Palliative resection is defined as patients with symptomatic metastatic colorectal cancer that undergoes resection of the primary tumor with the aim to relieve symptoms such as obstruction, bleeding or perforation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •adults undergoing elective colorectal cancer resection before and after April 1st 2016 at Zealand University Hospital, Denmark.
排除标准
- •palliative resection
- •preoperative use of opioids within the last 3 months
- •patients with a surgical complication requiring re-operation in general anesthesia.
研究组 & 干预措施
+NSAIDs
Patients undergoing elective colorectal cancer resection before april 1st 2016 were treated with paracetamol tablets 1000 mg and ibuprofen tablets 400 mg four times a day from the day of the operation and until discharge.
干预措施: NSAID (Drug)
结局指标
主要结局
Postoperative opioid-consumption
时间窗: from the day of operation and until discharge (median 3 days)
potential changes in the total p.n. use of opioids measured in oral morphine equivalent doses in mg (omeq)
次要结局
- mortality(From the day of operation and 3 to 5 years after (at the time of data collection).)
- Postoperative renal impact(from the day of operation and 7 days postoperatively or until discharge.)
- Colorectal cancer recurrence(120 days after surgery and until data collection.)
- Postoperative cardiac impact(was measured on day 1 to 4 after surgery or intil discharge.)
研究者
Stine Turino
Principal investigator
Zealand University Hospital
