Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01130675
First received: May 24, 2010
Last updated: June 10, 2013
Last verified: June 2013
  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

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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
Study Completion Date: December 2011
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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01130675

Locations
United States, Massachusetts
UMass Memorial Medical Center Memorial Campus
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: 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: June 10, 2013
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 August 28, 2014