Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to first bowel movement
研究概览
简要总结
Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged leading to increased cost. A recent randomized controlled trial from the University of Heidelberg showed that consumption of regular black coffee after colectomy is safe and associated with a significantly faster resumption of intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is unknown but caffeine seems to be the most likely stimulating agent.
Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy?
Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine, or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.
The study is a randomized, controlled trial, with blinding of physicians, patients and nursing stuff (evaluating the endpoints).
Primary endpoint will be the time to first bowel movement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano))
- •There will be no upper age limit. If elderly patients are considered fit for surgery, they will be included in the study.
- •Informed consent
- •Application of epidural analgesia
排除标准
- •Participation in another concurrent interventional trial
- •Need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction
- •Known hypersensitivity or allergy to caffeine/coffee
- •Expected lack of compliance
- •American Society of Anesthesiologists (ASA) Physical Status Score of IV or V
- •Impaired mental state or language problems
- •Alcoholism or drug abuse
- •Previous extensive abdominal surgery
- •Inflammatory bowel disease
- •Clinically significant cardiac arrhythmia
- •Cardiac insufficiency
- •Pregnancy, lactation, or childbearing potential without using adequate contraception
- •Intake of opioid analgesics, or steroids >5mg/d for ≥7 days before surgery
- •Under anti-depressive medication
- •Liver cirrhosis or compromised liver function (MELD score >15)
- •Emergency procedure
研究组 & 干预措施
Caffeine (100 mg)
Verum 1 with 100 mg caffeine
干预措施: Caffeine (100 mg) (Drug)
Caffeine (100 mg)
Verum 1 with 100 mg caffeine
干预措施: Radiopaque marker (Other)
Caffeine (200 mg)
Verum 2 with 200 mg caffeine
干预措施: Caffeine (200 mg) (Drug)
Caffeine (200 mg)
Verum 2 with 200 mg caffeine
干预措施: Radiopaque marker (Other)
corn starch (250 mg approx.)
approx. 250 mg corn starch as placebo
干预措施: corn starch (250 mg approx.) (Drug)
corn starch (250 mg approx.)
approx. 250 mg corn starch as placebo
干预措施: Radiopaque marker (Other)
结局指标
主要结局
Time to first bowel movement
时间窗: 7 days
Time from end of surgery (time of closing suture) until patient's first bowel movement (passage of stool) in hours. A patient is considered to have met the primary endpoint when he or she had first tolerated food (recovery of upper GI function) and experienced a bowel movement for the first time (recovery of lower GI function).
次要结局
- Blood pressure(7 days)
- Pulse(7 days)
- Intensive care(14 days)
- Time to first flatus(7 days)
- Time to tolerance of solid food(7 days)
- Postoperative vomiting events(7 days)
- Colonic passage time(4 days)
- Actual postoperative hospital stay(30 days)
- Theoretical postoperative hospital stay(30 days)
- Daily doses of analgetics(30 days)
- Postoperative pain(7 days)
- Postoperative mobilization(7 days)
- Overall fluid intake(7 days)
- Well-being(4 days)
- Sleep behaviour(4 days)
- Sleeping habits(4 days)
- Satisfaction with surgery(4 days)
- Consumption of sleep inducing drugs(7 days)
研究者
Thomas Steffen
Deputy head of department
Cantonal Hospital of St. Gallen