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

NCT ID: NCT01130675

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-12-31

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.

Conditions

Postoperative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eight ounces of caffeinated coffee for breakfast and lunch

Group Type: ACTIVE_COMPARATOR

caffeinated coffee

Intervention Type: OTHER

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

standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

caffeinated coffee

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UMass Memorial Medical Center Memorial Campus

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

H-13493

Identifier Type: -

Identifier Source: org_study_id