NCT01130675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

1.7 years

First QC Date

May 24, 2010

Last Update Submit

June 10, 2013

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

eight ounces of caffeinated coffee for breakfast and lunch

ACTIVE COMPARATOR
Other: caffeinated coffee

standard care

NO INTERVENTION

Interventions

caffeinated coffeeOTHER

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

eight ounces of caffeinated coffee for breakfast and lunch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective partial bowel resection with primary anastomosis for either cancer or benign disease.
  • Laparoscopy or laparotomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Memorial Medical Center Memorial Campus

Worcester, Massachusetts, 01605, United States

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 26, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(1)