Bowel Dysfunction, Pancreatic Diseases, Postoperative Complications, Postoperative Ileus
Conditions
Keywords
Randomised clinical trial, Pancreatic surgery
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 trial is to investigate whether early coffee consumption can accelerate the recovery of bowel function after open pancreaticoduodenectomy.
Interventions
DIETARY_SUPPLEMENTStandard coffee
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
DIETARY_SUPPLEMENTCaffeine-free coffee
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
DIETARY_SUPPLEMENTDrinking water
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants and staff were masked about the type of coffee administrated (standard coffee versus caffeine-free coffee). Masking about administration of hot water is not feasible.
Intervention model description
randomised, partilly blinded trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Bowel Movement | 96 hours. | Time to first bowel movement (expressed by hours from the time of surgical procedure ending). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORGiuseppe Malleo, MD PhD
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed