Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

NCT03097900 | Completed Phase 2

• 1 other identifier: CAFFEINE-HMO-CTIL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Ileus

Keywords

Postoperative Ileus; Caffeine Citrate

Outcome Measures

Primary Outcomes (1)

• First postoperative flatus

  The time in hours from end of surgery to first flatus.

  Throughout hospital stay for a maximum of 30 days

Secondary Outcomes (3)

• First bowel movement

  Throughout hospital stay for a maximum of 30 days

• Tolerance of solid diet

  Throughout hospital stay for a maximum of 30 days

• Length of postoperative hospital stay.

  Throughout hospital stay for a maximum of 30 days

Study Arms (2)

Treatment (Caffeine Citrate) group

ACTIVE COMPARATOR

25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day 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.

Drug: Caffeine Citrate

Placebo (Water) group

PLACEBO COMPARATOR

25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day 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.

Other: Water

Interventions

Caffeine Citrate DRUG

25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day 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.

Also known as: Cafcit

Treatment (Caffeine Citrate) group

Water OTHER

25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day 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.

Placebo (Water) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
• Males and females, 18 to 80 years of age inclusive at the time of study screening;
• Due to undergo large partial / total bowel resection via laparotomy or laparoscopy with primary anastomosis.

You may not qualify if:

• Scheduled for a colon resection with stoma creation or multi-visceral resection.
• Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
• American Society of Anesthesiologists (ASA) Class IV or V
• History of abdominal carcinomatosis
• History of radiation enteritis
• Children \<18 or adults \> 80 years of age
• Pregnant women
• Known allergy to caffeine
• Consumption of more than 800 milligrams of caffeine (8-10 cups of coffee) daily on a regular basis
• Complete abstention of caffeine consumption on a regular basis
• 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
• Postoperative ventilation, pressor requirement or ICU stay
• Liver failure or/and liver cirrhosis (MELD\>15)
• Urgent surgery e.g. emergent laparotomy, sepsis, diverting stoma.
• Opioid treatment for at least a week before surgery.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem Region, Israel

Location

Related Publications (20)

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• Parnasa SY, Marom G, Bdolah-Abram T, Gefen R, Luques L, Michael S, Mizrahi I, Abu-Gazala M, Rivkind AI, Mintz Y, Pikarsky AJ, Shussman N. Does caffeine enhance bowel recovery after elective colorectal resection? A prospective double-blinded randomized clinical trial. Tech Coloproctol. 2021 Jul;25(7):831-839. doi: 10.1007/s10151-021-02450-7. Epub 2021 Apr 26.

  PMID: 33900493 DERIVED

Related Links

• Ref 11. Mayo Clinic staff. Caffeine content for coffee, tea, soda and more. \[Accessed March 14, 2017\]

MeSH Terms

Interventions

caffeine citrate; Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Noam Shussman, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 31, 2017
• Study Start: November 2, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 11, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)