Coffee After Pancreatic Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Ileus, Postoperative Complications, Bowel Dysfunction, Pancreatic Diseases

Intervention / Treatment
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* Dietary Supplement: Standard coffee
* Dietary Supplement: Caffeine-free coffee
* Dietary Supplement: Drinking water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised placebo-controlled single blinded trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard coffee<br>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). | Dietary Supplement: Standard coffee<br>* One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).<br>|
| Placebo Comparator: caffeine-free coffee<br>Hot caffeine-free coffee (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three). | Dietary Supplement: Caffeine-free coffee<br>* One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).<br>|
| Sham Comparator: water<br>Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three). | Dietary Supplement: Drinking water<br>* One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Bowel Movement | Time to first bowel movement (expressed by hours from the time of surgical procedure ending). | 96 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Flatus | Time to first flatus (expressed by hours from the time of surgical procedure ending). | 96 hours | 
| Tolerance to solid food | 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. | 96 hours | 
| Length of stay | Length of stay expressed by days from intervention to discharge. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomised clinical trial, Pancreatic surgery