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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01130675
Study type Interventional
Source University of Massachusetts, Worcester
Contact
Status Completed
Phase Phase 3
Start date April 2010
Completion date December 2011

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