The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.

NCT02639728 | Completed

• 1 other identifier: Pro00030891
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee stimulates colonic activity, most notably in the transverse/descending colon, in magnitude similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. \[1\] Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is significantly higher than after water intake. This may result in an earlier desire to defecate. \[2\] Coffee has also been shown to have an effect on defecation by increasing rectal tone by 45% (measured with a barostat) thirty minutes after consumption. \[3\]

Conditions

Postoperative Ileus

Keywords

Bowel surgery; Postoperative bowel recovery

Outcome Measures

Primary Outcomes (1)

• GI Function

  Time to first flatus and/or bowel movement as assessed twice per day by inquiry from the primary team and study investigators.

  30 days

Secondary Outcomes (6)

• Hospital Days

  30 days

• Vomiting

  30 days

• Nasogastric tube

  30 days

• Anastomotic leak

  30 days

• Wound Infection

  30 days

Study Arms (3)

Regular coffee

EXPERIMENTAL

Will receive a 4oz cup coffee, three times daily (at 8:00, 12:00, and 16:00 hours)and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first.

Other: Regular Coffee

Decaffeinated coffee

EXPERIMENTAL

Will receive a 4oz cup of decaffeinated coffee (at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first.

Other: Decaffeinated coffee

Warm water

EXPERIMENTAL

Will receive a 4oz cup of warm water at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first.

Other: Warm water

Interventions

Regular Coffee OTHER

Regular coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.

Regular coffee

Decaffeinated coffee OTHER

Decaffeinated coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.

Decaffeinated coffee

Warm water OTHER

Warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.

Warm water

Eligibility Criteria

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

You may qualify if:

• Patients due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy with primary anastomosis. Planned postoperative care includes removing the NG tube at the end of surgery and clear liquid diet of POD #1.
• Patients, both male and female, must be between the ages of 18-85.
• Patients must be able to freely give written informed consent to participate in the study and have signed the Informed Consent Form.

You may not qualify if:

• Patients with a history of prior intestinal surgery, excluding appendectomy.
• Patients who require an ostomy during their elective colorectal surgery.
• Patients who require postoperative ventilation, pressors, or ICU stay.
• Those who are mentally incompetent, unable, or unwilling to provide informed consent or comply with study procedures.
• American Society of Anesthesiologist (ASA) class IV or V.
• Those with a history of carcinomatosis.
• Those with a history of radiation enteritis.
• Women who are pregnant.
• Patients who have a history of epilepsy.
• Patients with prior cardiovascular disorders including uncontrolled hypertension, prior myocardial infarction, or heart failure.
• Patients with peptic ulcers.
• Patients with glaucoma.
• Non-English Speakers.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Yosef Nasseri, MD

Los Angeles, California, 90048, United States

Location

Related Publications (5)

• Rao SS, Welcher K, Zimmerman B, Stumbo P. Is coffee a colonic stimulant? Eur J Gastroenterol Hepatol. 1998 Feb;10(2):113-8. doi: 10.1097/00042737-199802000-00003.

  PMID: 9581985 BACKGROUND

• Lohsiriwat S, Kongmuang P, Leelakusolvong S. Effects of caffeine on anorectal manometric findings. Dis Colon Rectum. 2008 Jun;51(6):928-31. doi: 10.1007/s10350-008-9271-y. Epub 2008 Mar 19.

  PMID: 18350336 BACKGROUND

• Sloots CE, Felt-Bersma RJ, West RL, Kuipers EJ. Stimulation of defecation: effects of coffee use and nicotine on rectal tone and visceral sensitivity. Scand J Gastroenterol. 2005 Jul;40(7):808-13. doi: 10.1080/00365520510015872.

  PMID: 16109656 BACKGROUND

• Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.

  PMID: 22987303 BACKGROUND

• Nasseri Y, Kasheri E, Oka K, Zhu R, Smiley A, Cohen J, Ellenhorn J, Barnajian M. Does coffee affect bowel recovery following minimally invasive colorectal operations? A three-armed randomized controlled trial. Int J Colorectal Dis. 2023 Jul 20;38(1):199. doi: 10.1007/s00384-023-04494-7.

  PMID: 37470901 DERIVED

Study Officials

• Yosef Nasseri, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 24, 2015
• Study Start: November 1, 2013
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

US (1)