Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection?
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Purpose
The purpose of this study is to determine if consuming an 8 ounce cup of coffee with breakfast and lunch is effective in preventing or reducing postoperative ileus.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Ileus |
Other: caffeinated coffee |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection? A Prospective Randomized Clinical Trial |
- Resolution of ileus [ Time Frame: a mean difference of 24 hours to be significant ] [ Designated as safety issue: No ]Measured by hours to first flatus or bowel movement and tolerance of solid food.
| Enrollment: | 44 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: eight ounces of caffeinated coffee for breakfast and lunch |
Other: caffeinated coffee
8 oz. of caffeinated cofee/breakfast&noon meal. No intervention for 2nd arm.
|
| No Intervention: standard care |
Detailed Description:
Recent evidence has shown that a multimodal rehabilitation program can accelerate recovery of GI function after colon resection. 8 A multicenter, randomized, placebo-controlled, double-blind, phase 3 trial demonstrated that Alvimopan, a peripherally acting mu-opioid receptor antagonist, appears to accelerate GI tract recovery by 1 day, and reduces postoperative ileus-related morbidity without compromising opioid analgesia. 9 Asao et al demonstrated that gum chewing can accelerate recovery of GI function, also by 1 day, after abdominal surgery. 10 Epidural anesthesia has been shown to shorten duration of POI, as well as improve pain control, decrease pulmonary complications, and quicken recovery times. However, it does not appear to reduce overall length of stay. 4 However, Neudecker et al. were unable to reproduce the results of previous trials evaluating the effect of thoracic epidural analgesia on duration of postoperative ileus following laparoscopic sigmoid resection. 11 Given conflicting data, no one single measure has been adopted for the prevention POI.
Recent evidence has shown that coffee may be a stimulant for the GI Tract. A small study of 16 healthy volunteers demonstrated that coffee appears to increase rectal tone thus implying an impact on defecation mechanics.12 Furthermore, several studies have demonstrated caffeinated coffee to be a stimulant of motor activity in the colon.13,14 Given its potential pro-motility properties in the GI tract, it seems reasonable to postulate that coffee, a commonly consumed product by the general public, may play a role in shortening and possibly preventing POI. This directly impacts overall patient satisfaction but will reduce length of stay and overall hospital costs.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elective partial bowel resection with primary anastomosis for either cancer or benign disease.
- Laparoscopy or laparotomy
Exclusion Criteria:
- Total colectomy
- Colostomy
- Ileostomy
- Reversal of a stoma or synchronous resection
- Complete small or large bowel obstruction
Scheduled to receive other treatments or techniques to reduce ileus
1. epidural anesthetic tecniques
- Nasogastric tube for any length of timein the post-op period.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Karim Alavi, Study Principle Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01130675 History of Changes |
| Other Study ID Numbers: | H-13493 |
| Study First Received: | May 24, 2010 |
| Last Updated: | November 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Ileus Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013