Postoperative Ileus Clinical Trial
Official title:
Prospective Study of the Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
Verified date | November 2022 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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]
Status | Completed |
Enrollment | 90 |
Est. completion date | March 23, 2022 |
Est. primary completion date | March 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - • 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. Exclusion Criteria: - • Study patients who do not meet inclusion criteria will not qualify for study inclusion. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Yosef Nasseri, MD | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
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. — View Citation
Müller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Büchler 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. — View Citation
Rao SS, Welcher K, Zimmerman B, Stumbo P. Is coffee a colonic stimulant? Eur J Gastroenterol Hepatol. 1998 Feb;10(2):113-8. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Hospital Days | Evaluation of length of postoperative hospital stay, will be recorded from medical records. | 30 days | |
Secondary | Vomiting | Evaluation of number of episodes of vomiting will be collected from medical records | 30 days | |
Secondary | Nasogastric tube | Number of nasogastric tube (re)insertion, will be collected from medical records | 30 days | |
Secondary | Anastomotic leak | Evaluation of any anastomotic leak will be collected from medical records | 30 days | |
Secondary | Wound Infection | Evaluation for any wound infection will be collected from medical records | 30 days | |
Secondary | Abscesses | Evaluation for any intra-abdominal abscess will be collected from medical records | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04205058 -
Coffee After Pancreatic Surgery
|
N/A | |
Completed |
NCT02232893 -
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
|
Phase 2 | |
Not yet recruiting |
NCT05001763 -
Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy
|
Phase 2 | |
Active, not recruiting |
NCT04547868 -
Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery
|
N/A | |
Completed |
NCT02815956 -
Tibial Nerve Stimulation and Postoperative Ileus
|
N/A | |
Completed |
NCT02947269 -
Prucalopride in Postoperative Ileus
|
Phase 3 | |
Recruiting |
NCT05512741 -
Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
|
||
Recruiting |
NCT04675606 -
Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
|
N/A | |
Completed |
NCT02161367 -
Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery
|
Phase 4 | |
Completed |
NCT01956643 -
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
|
N/A | |
Completed |
NCT00464425 -
Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery
|
Phase 3 | |
Completed |
NCT00402961 -
Trial of Acupuncture for Reduction of Post-Colectomy Ileus
|
Phase 2 | |
Terminated |
NCT04100265 -
ANTERO-5: Gastric Motility in Postoperative Ileus
|
N/A | |
Recruiting |
NCT04090073 -
Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
|
N/A | |
Recruiting |
NCT03222557 -
Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer
|
N/A | |
Withdrawn |
NCT02261454 -
RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children
|
N/A | |
Completed |
NCT02004652 -
Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery
|
Phase 2 | |
Completed |
NCT00509327 -
Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery
|
Phase 4 | |
Completed |
NCT03097900 -
Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?
|
Phase 2 | |
Completed |
NCT03143621 -
The Effect of Coffee After Resection of Small Bowel
|
N/A |