Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery? A Vanguard Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 6
- 主要终点
- Ability to deliver intervention patient is randomized to receive
研究概览
简要总结
Disruption of the normal gastrointestinal (GI) motility is a well-known consequence of major surgery. The pathophysiology behind this phenomenon is not fully understood but involves the autonomic nervous system as well as a systemic stress response to surgery. A number of factors interfere with GI motor activity, such as the direct manipulation of intestines during surgery and the use of opioid analgesia. Post-operative ileus (POI) refers to a delay in regaining GI motility beyond the anticipated normal duration of time. Signs and symptoms include nausea, vomiting, abdominal distention, the absence of flatus or stool in the preceding 24 hours, and/or an inability to tolerate oral intake. The incidence of POI in abdominal surgery is estimated to be approximately 10%-30%. Beyond increased patient discomfort and distress, the development of POI is associated with increased healthcare costs.
Coffee is a popular beverage: two thirds of Canadians are coffee drinkers, averaging approximately 3.2 cups per day. Coffee is composed of hundreds of chemicals, many with demonstrated pharmacologic effects. The most well-known of these compounds is caffeine, known to exert a stimulatory effect on the cardiovascular and nervous system. A recent systematic review of 7 randomized controlled trials (N=606 colorectal and gynecology surgical patients) determined that the consumption of coffee reduced the time of several measures of GI recovery, such as time to tolerance of food, without any increased rate of complications or adverse events although overall, the evidence was graded as low to moderate certainty, and further confirmatory studies are needed. In this trial, patients aged 18 years or higher who undergo laparoscopic or open abdominal surgery, with an estimated length of stay > 24 hours will be randomized to receive approximately one cup of either coffee, decaffeinated coffee, or warm water, three times daily. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest include: time to first flatus, time to first bowel movement, placement of an NG tube, length of stay in hospital, 30-day mortality, and 30-day postoperative complications.
详细描述
Background/rationale: The development of POI is a common complication of surgery that is detrimental to patient well-being and ultimately leads to significant healthcare costs. Coffee is a popular drink among Canadians and appears to exert a positive effect on GI motility. This beverage may provide an inexpensive, easily administered and well-tolerated intervention to accelerate post-operative GI recovery, and thus reduce POI. The current literature, while promising, is insufficient and merits further investigation in the form of a high-quality randomized controlled trial.
Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives:
- To assess our ability to accrue patients using the IMPACTS Program platform, at multiple institutions, over the course of one year.
- To assess our ability to adaptively randomize patients and deliver the randomized assignment using the IMPACTS Program platform, over the course of one year.
- To assess our ability to collect complete data directly from participants (patients and clinicians) on time to first flatus and time to first bowel movement over the course of one year.
- To examine our ability to carry out data linkages using the IMPACTS Program platform over the course of one year.
- To estimate the change in time to first flatus to inform the sample size calculation for the definitive trial.
Study design: This is a multicentre, pragmatic, 3-arm parallel group Vanguard feasibility randomized controlled trial. Patients will be randomly assigned to consume coffee, decaffeinated coffee, or warm water. If feasibility is demonstrated during the pilot trial, we will plan to conduct a definitive trial. If there are only minimal changes to the protocol, we will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design).
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Planned elective laparoscopic or open abdominal surgery
- •Patient is scheduled to remain in hospital for at least one night, post-operatively
排除标准
- •Known intolerance to coffee or caffeine
- •Unwilling to stop current caffeine consumption (coffee or tea) during trial
研究组 & 干预措施
Warm water
Warm water beverage
干预措施: Warm water (Other)
Coffee
Caffeinated coffee beverage
干预措施: Coffee (Other)
Decaffeinated coffee
Decaffeinated coffee beverage
干预措施: Decaffeinated Coffee (Other)
结局指标
主要结局
Ability to deliver intervention patient is randomized to receive
时间窗: 1 year
Feasible if \> 90% of patients receive the correct intervention
Measurement of baseline data
时间窗: 1 year
1. Median number of hours until flatus in control group 2. Median number of hours until flatus in coffee and decaffeinated coffee groups
Assessment of accrual
时间窗: 1 year
Average number of patients enrolled per month across the 3 sites for the trial: feasible if 10 or more
Ability to link data from patient-reported outcome measures with Institute for Clinical/Evaluative Sciences and National Surgical Quality Improvement Program datasets
时间窗: 1 year
Feasible if linkage is possible in \> 90% of patients
Ability to collect complete data for patient-reported outcomes
时间窗: 1 year
Feasible if \> 80% of data is collected
次要结局
未报告次要终点
研究者
Dr. Paul Karanicolas
Scientist
Sunnybrook Health Sciences Centre
