Coffee After Pancreatic Surgery

Not Applicable

• Conditions: Bowel Dysfunction; Pancreatic Diseases; Postoperative Ileus; Postoperative Complications
• Interventions: Dietary Supplement: Caffeine-free coffee; Dietary Supplement: Drinking water; Dietary Supplement: Standard coffee

• Registration Number: NCT04205058
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Study Timeline

• Study Start: 2019-09-05
• Status Verified: 2019-12
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-17
• Last Update Submitted: 2019-12-17
• Study First Posted: 2019-12-19
• Last Update Posted: 2019-12-19
• Primary Completion: 2021-12-05
• Study Completion: 2021-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
First Bowel Movement	96 hours.	Time to first bowel movement (expressed by hours from the time of surgical procedure ending).

Secondary Outcome Measures

Name	Time	Method
First Flatus	96 hours	Time to first flatus (expressed by hours from the time of surgical procedure ending).
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.
Length of stay	90 days	Length of stay expressed by days from intervention to discharge.

Trial Locations

Locations (1)

AOUI Verona; 🇮🇹 Verona, Italy