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COPS: Coffee After Pancreatic Surgery

Sponsor
Azienda Ospedaliera Universitaria Integrata Verona (Other)
Overall Status
Unknown status
CT.gov ID
NCT04205058
Collaborator
(none)
199
Enrollment
1
Location
3
Arms
27
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Standard coffee
  • Dietary Supplement: Caffeine-free coffee
  • Dietary Supplement: Drinking water
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
199 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomised placebo-controlled single blinded trialrandomised placebo-controlled single blinded trial
Masking:
Single (Participant)
Masking Description:
Participants are masked about the type of coffee administrated (standard coffee versus caffeine-free coffee). Masking about administration of hot water is not feasible.
Primary Purpose:
Treatment
Official Title:
Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial
Actual Study Start Date :
Sep 5, 2019
Anticipated Primary Completion Date :
Dec 5, 2021
Anticipated Study Completion Date :
Dec 5, 2021

Arms and Interventions

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.).

Outcome Measures

Primary Outcome Measures

  1. First Bowel Movement [96 hours.]

    Time to first bowel movement (expressed by hours from the time of surgical procedure ending).

Secondary Outcome Measures

  1. First Flatus [96 hours]

    Time to first flatus (expressed by hours from the time of surgical procedure ending).

  2. Tolerance to solid food [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.

  3. Length of stay [90 days]

    Length of stay expressed by days from intervention to discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOUI Verona Verona Italy 37124

Sponsors and Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier:
NCT04205058
Other Study ID Numbers:
  • 2296CESC
First Posted:
Dec 19, 2019
Last Update Posted:
Dec 19, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona
Randomised clinical trial
Pancreatic surgery
Additional relevant MeSH terms:
Intestinal Diseases
Pancreatic Diseases
Postoperative Complications
Caffeine

Study Results

No Results Posted as of Dec 19, 2019