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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130675
• Other study ID #: H-13493
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2010
• Last updated: June 10, 2013
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2013
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

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

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center Memorial Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of ileus	Measured by hours to first flatus or bowel movement and tolerance of solid food.	a mean difference of 24 hours to be significant	No