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Completed

NCT Number: NCT01130675

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UMass Memorial Medical Center Memorial Campus

Worcester, Massachusetts, 01605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • epidural anesthetic tecniques
  • Nasogastric tube for any length of timein the post-op period.

Treatment and study plan

Caffeinated coffee

Other

8 oz. of caffeinated cofee/breakfast&noon meal. No intervention for 2nd arm.

Primary outcomes

  1. Resolution of ileus

    Time frame: a mean difference of 24 hours to be significant

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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection? A Prospective Randomized Clinical Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 26, 2010
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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