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Patients after laparoscopic colectomy will receive 3 times daily capsules with 100 mg caffeine together with the meals.

First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.

Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.

Caffeine (100 mg)

Patients after laparoscopic colectomy will receive 3 times daily capsules with 200 mg caffeine together with the meals.

First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.

Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.

Caffeine (200 mg)

Patients after laparoscopic colectomy will receive 3 times daily capsules with 250 mg corn starch together with the meals.

First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.

Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.

corn starch (250 mg approx.)

On the morning of the first, second and third day after surgery patients will take 1 capsule each day with radiopaque markers .

On day 4 after surgery an abdominal X-ray will be performed to localize the markers.

Each gelatin capsule contains 10 markers consisting of polyurethane encapsulated barium sulfate (40%).

Radiopaque marker

Thomas Steffen, MD

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.

Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?

Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial

Questionnaire evaluation the caffeine consumption of patients (type of beverages, amount etc)

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).

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 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.

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).

Number of days from surgery until actual discharge.

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)

Amount, type, and time of application of analgetics will be obtained from medical and nursing records.

evaluated on the numeric rating scale (0 - 10, steps of 1)

Scoring:

* 0: 24 h in bed
* 1: Out of bed only to go to bathroom
* 2: Out of bed on free will

3 times daily (or more often if required)

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)

Leeds Sleep Evaluation Questionnaire (LSEQ) on day 2 and 4 after surgery. (Parrott 1986)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?	NCT02510911	Postoperative I... Laparoscopic Co... Colorectal Neop... Diverticulitis	Caffeine (100 m... Caffeine (200 m... corn starch (25... Radiopaque mark...	18 Years -	Cantonal Hospital of St. Gallen
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?	NCT02510911	Postoperative I... Laparoscopic Co... Colorectal Neop... Diverticulitis	Caffeine (100 m... Caffeine (200 m... corn starch (25... Radiopaque mark...	18 Years -	Cantonal Hospital of St. Gallen

Spots Global Cancer Trial Database for caffeine (200 mg)