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

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
caffeinated coffee
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMass Memorial Medical Center Memorial Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

eight ounces of caffeinated coffee for breakfast and lunch

standard care

Arm Description

Outcomes

Primary Outcome Measures

Resolution of ileus
Measured by hours to first flatus or bowel movement and tolerance of solid food.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2010
Last Updated
June 10, 2013
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT01130675
Brief Title
Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection?
Official Title
Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection? A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eight ounces of caffeinated coffee for breakfast and lunch
Arm Type
Active Comparator
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
caffeinated coffee
Intervention Description
8 oz. of caffeinated cofee/breakfast&noon meal. No intervention for 2nd arm.
Primary Outcome Measure Information:
Title
Resolution of ileus
Description
Measured by hours to first flatus or bowel movement and tolerance of solid food.
Time Frame
a mean difference of 24 hours to be significant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UMass Memorial Medical Center Memorial Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

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

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