Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative ileus is a frequently occurring surgical complication. It is defined as temporary inhibition of propulsive bowel activity and is manifested by abdominal distention, nausea, vomiting and diet intolerance. It may lead to a prolonged hospital stay, hospital-acquired infections or complications that may require additional treatments (e.g. analgesia, fluids, electrolyte replacement, nasogastric tube decompression), and as a result increase medical costs.

Previous studies showed that postoperative coffee consumption shortens the time to first bowel movement after colorectal resections. However, none could explain the mechanism by which coffee stimulates intestinal motility and the determinant agent for this action is still up for discussion (either caffeine or another coffee component).

Coffee has a negligible caloric content; It has a pH that varies from 5 to 6 (less acidity than other beverages that have no similar effect on bowel motility) and it is hypotonic. Therefore, it is highly unlikely that bowel motility is due to the physical properties of the coffee. Much more likely, that one (or more) of the numerous phytochemicals of the coffee bean are responsible for this effect, when the most obvious candidate seems to be caffeine. However, as mentioned above, very little evidence exists that caffeine was responsible for the observed effect on colonic function in previous studies.

The purpose of this single-centered, prospective, single blinded, randomized clinical trial is to evaluate whether the use of caffeine in the post-operative period significantly reduces the duration of postoperative ileus, and therefore, improves recovery and shorten the hospital stay.

The study hypothesis is that post-operative use of caffeine will reduce time to recovery of GI function (post-operative ileus) by at least 15 hours and thus reduce hospital length of stay by at least 15 hours in patients undergoing elective colorectal operations.

50 patients due to undergo large bowel resection via laparotomy or laparoscopy will be enrolled and randomized (1:1) to those who will receive caffeine (100 mg 3 times per day) and those who will receive placebo (tap water) starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Caffeine; Caffeine citrate; Citric Acid

Criteria

Key Inclusion Criteria

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;

2. Males and females, 18 to 80 years of age inclusive at the time of study screening;

3. Due to undergo large partial / total bowel resection via laparotomy or laparoscopy with primary anastomosis.

Key Exclusion Criteria

1. Scheduled for a colon resection with stoma creation or multi-visceral resection.

2. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures

3. American Society of Anesthesiologists (ASA) Class IV or V

4. History of abdominal carcinomatosis

5. History of radiation enteritis

6. Children <18 or adults > 80 years of age

7. Pregnant women

8. Known allergy to caffeine

9. Consumption of more than 800 milligrams of caffeine (8-10 cups of coffee) daily on a regular basis

10. Complete abstention of caffeine consumption on a regular basis

11. Consumption of drugs which are either substrates or inhibitors of CYP1A2 enzyme (Ciprofloxacin, Fluvoxamine or Clozapine( at the time of the study, due to expected change of caffeine metabolism it these patients

12. Postoperative ventilation, pressor requirement or ICU stay

13. Liver failure or/and liver cirrhosis (MELD>15)

14. Urgent surgery e.g. emergent laparotomy, sepsis, diverting stoma.

15. Opioid treatment for at least a week before surgery.

16. Prior extensive abdominal surgery (not including caesarean section, appendectomy, cholecystectomy or hernia repair).

17. Known impaired mental status or language difficulties.

18. Participation in another interventional trial.