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OpenTrials
Completed

NCT Number: NCT04205058

Coffee After Pancreatic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUI Verona

Verona, 37124, Italy

About this study

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 trial is to investigate whether early coffee consumption can accelerate the recovery of bowel function after open pancreaticoduodenectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard coffee

Dietary Supplement

One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

Caffeine-free coffee

Dietary Supplement

One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

Drinking water

Dietary Supplement

One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

Primary outcomes

  1. First Bowel Movement

    Time frame: 96 hours.

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

Secondary outcomes

  1. First Flatus

    Time frame: 96 hours

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

  2. 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.

  3. Length of stay

    Time frame: 90 days

    Length of stay expressed by days from intervention to discharge.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Acronym: COPS

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2019
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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