Postoperative Ileus Clinical Trial
Official title:
Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?
Verified date | March 2019 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem Region |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First postoperative flatus | The time in hours from end of surgery to first flatus. | Throughout hospital stay for a maximum of 30 days | |
Secondary | First bowel movement | The time in hours from end of surgery to first bowel movement. | Throughout hospital stay for a maximum of 30 days | |
Secondary | Tolerance of solid diet | The time in hours from end of surgery to first solid meal tolerated (the first time the patient is able to eat any food requiring chewing, without vomiting or going back to liquid diet) | Throughout hospital stay for a maximum of 30 days | |
Secondary | Length of postoperative hospital stay. | The postoperative hospital stay is the number of hours from surgery until discharge. The criteria for hospital discharge include stable vital signs with no febrile morbidity for =24 hours, passage of stool, toleration of a solid diet and the absence of other complications. | Throughout hospital stay for a maximum of 30 days |
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