Coffee After Pancreatic Surgery (COPS)

Integrated University Hospital Trust of Verona

Status: Unknown

Conditions: Postoperative Complications; Pancreatic Diseases; Postoperative Ileus; Bowel Dysfunction

Treatments: Dietary Supplement: Drinking water; Dietary Supplement: Caffeine-free coffee; Dietary Supplement: Standard coffee

Study type: Interventional

Funder types: Other

Identifiers

NCT04205058

2296CESC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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199 participants in 3 patient groups, including a placebo group

standard coffee

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Standard coffee

caffeine-free coffee

Placebo Comparator group

Description:

Hot caffeine-free coffee (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).

Treatment:

Dietary Supplement: Caffeine-free coffee

water

Sham Comparator group

Description:

Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).

Treatment:

Dietary Supplement: Drinking water