Coffee After Pancreatic Surgery (COPS)

December 17, 2019 updated by: Azienda Ospedaliera Universitaria Integrata Verona

Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial

Postoperative ileus is a common complication after major abdominal surgery. A positive effect of coffee to bowel movement has been described after colorectal and gynecologic interventions. The objective of this randomised controlled trial is to investigate whether the implementation of a fast track protocol with early coffee consumption accelerates the recovery of bowel function after pancreaticoduodenectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postoperative ileus (POI) is a common disorder after major abdominal surgery, affecting up to 40% of patients undergoing laparotomy. POI is described as the time between surgery and the first passage of flatus and/or stool and tolerance of oral diet. It could be recognised as postoperative complication when is defined as two or more of nausea/vomiting, inability to tolerate oral diet over 24 h, absence of flatus over 24 h, abdominal distention and radiologic confirmation on or after day 4 postoperatively without prior resolution. Multimodal approaches have been described to treat POI; among them, the early consumption of coffee showed a substantial benefit after colorectal and gynecologic surgery. The objective of this randomised placebo-controlled trial is to investigate whether early coffee consumption can accelerate the recovery of bowel function after open pancreaticoduodenectomy.

Study Type

Interventional

Enrollment (Anticipated)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37124
        • Recruiting
        • AOUI Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective open pancreaticoduodenectomy
  • Age ≥ 18 years
  • American Society Anesthesiologists (ASA) score ≤ 3
  • Ability of the subject to understand aims and clinical consequences of the trial
  • Written informed consent

Exclusion Criteria:

  • American Society Anesthesiologists (ASA) score ≥ 4
  • Need for early postoperative Intensive Care Unit care
  • Need for naso-gastric tube on postoperative day one
  • Intolerance to coffee
  • Refuse to assume coffee
  • Pregnancy
  • Surgical procedures performed different from pancreaticoduodenectomy
  • Impaired mental status or language problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: standard coffee
Hot standard coffee with caffeine (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
Dietary supplement: Standard coffee
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
PLACEBO_COMPARATOR: caffeine-free coffee
Hot caffeine-free coffee (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
Dietary supplement: Caffeine-free coffee
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
SHAM_COMPARATOR: water
Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
Dietary supplement: Drinking water
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Bowel Movement
Time Frame: 96 hours.
Time to first bowel movement (expressed by hours from the time of surgical procedure ending).
96 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Flatus
Time Frame: 96 hours
Time to first flatus (expressed by hours from the time of surgical procedure ending).
96 hours
Tolerance to solid food
Time Frame: 96 hours
Time to tolerance to solid food (expressed by hours from the time of surgical procedure ending). Tolerance was defined as the ability to eat at least half of the solid food served by hospital staff.
96 hours
Length of stay
Time Frame: 90 days
Length of stay expressed by days from intervention to discharge.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

  • Study Director: Claudio Bassi, MD, Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2019

Primary Completion (ANTICIPATED)

December 5, 2021

Study Completion (ANTICIPATED)

December 5, 2021

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (ACTUAL)

December 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2296CESC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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