Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?
- Conditions
- Postoperative IleusLaparoscopic Colectomy Without Stoma FormationColorectal NeoplasmDiverticulitis
- Interventions
- Other: Radiopaque marker
- Registration Number
- NCT02510911
- Lead Sponsor
- Thomas Steffen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Caffeine (100 mg) Radiopaque marker Verum 1 with 100 mg caffeine Caffeine (200 mg) Radiopaque marker Verum 2 with 200 mg caffeine corn starch (250 mg approx.) Radiopaque marker approx. 250 mg corn starch as placebo Caffeine (100 mg) Caffeine (100 mg) Verum 1 with 100 mg caffeine Caffeine (200 mg) Caffeine (200 mg) Verum 2 with 200 mg caffeine corn starch (250 mg approx.) corn starch (250 mg approx.) approx. 250 mg corn starch as placebo
- Primary Outcome Measures
Name Time Method Time to first bowel movement 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).
- Secondary Outcome Measures
Name Time Method Blood pressure 7 days 3 times daily
Pulse 7 days 3 times daily (or more often if required)
Intensive care 14 days number of days in intensive care unit
Well-being 4 days well-being evaluating on day 2 and 4 after surgery using the Basle mental state scale as well as 5 additional items to evaluate the effects of caffeine. (Hobi 1985, Hobi 1989)
Time to first flatus 7 days Time from end of surgery until patient's first flatus in hours. The passage of flatus will be determined by questioning the patient; the passage of a bowel movement will be determined by reference to nursing records or by the clinical judgment of the investigator or designee following questioning the patient.
Time to tolerance of solid food 7 days Time from end of surgery until patient tolerates intake of solid food in hours. Tolerance of food is defined as the first time the patient is able to eat solid food (any food re-quiring chewing) without vomiting or significant nausea within 4 h after the meal, and without reversion to only enteral fluids.
Postoperative vomiting events 7 days Number of times patient has to vomit.
Colonic passage time 4 days On day 1, 2 and 3 after surgery patients take one capsule with radioopaque markers. On day 4 location and count of markers is determined by X-ray imaging and the colonic passage time is determined (Metcalf 1987).
Actual postoperative hospital stay 30 days Number of days from surgery until actual discharge.
Theoretical postoperative hospital stay 30 days Days from surgery until patient would be fit for release. Often patients stay longer in hospital than clinically required. Thus, evaluation of theoretical hospital stay.
A patient is fit for release if:
* there had been bowel movement
* solid food is tolerated
* no serious pain
* unproblematic mobilisation
* surgical wound shows no sign of inflammation, or wound can be treated well in an outpatient setting
* normal inflammatory markers (≤135 mg/l C-reactive protein (CRP), ≤9 10⁹/l white blood cell count)Daily doses of analgetics 30 days Amount, type, and time of application of analgetics will be obtained from medical and nursing records.
Postoperative pain 7 days evaluated on the numeric rating scale (0 - 10, steps of 1)
Postoperative mobilization 7 days Scoring:
* 0: 24 h in bed
* 1: Out of bed only to go to bathroom
* 2: Out of bed on free willOverall fluid intake 7 days all fluids in ml per day
Sleep behaviour 4 days Leeds Sleep Evaluation Questionnaire (LSEQ) on day 2 and 4 after surgery. (Parrott 1986)
Sleeping habits 4 days Questionnaire evaluating duration and deepness of sleep.
Satisfaction with surgery 4 days Questionnaire on day 4 about satisfaction of treatment
Consumption of sleep inducing drugs 7 days amount and type of sleep inducing drugs
Trial Locations
- Locations (1)
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
🇨🇭St. Gallen, Switzerland