Clinical trial NCT04205058: Coffee After Pancreatic Surgery
Official title: Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Ileus
Postoperative Complications
Bowel Dysfunction
Pancreatic Diseases
Keywords: Randomised clinical trial
Pancreatic surgery
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised placebo-controlled single blinded trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: First Bowel Movement
timeFrame: 96 hours.
Secondary outcomes:
measure: First Flatus
timeFrame: 96 hours
measure: Tolerance to solid food
timeFrame: 96 hours
measure: Length of stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Claudio Bassi, MD
role: STUDY_DIRECTOR
References:
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