NCT04205058

Coffee After Pancreatic Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Ileus
• Postoperative Complications
• Bowel Dysfunction
• Pancreatic Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standard coffee	One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
DIETARY_SUPPLEMENT	Caffeine-free coffee	One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
DIETARY_SUPPLEMENT	Drinking water	One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

Timeline

• Start date: 2019-09-05
• Primary completion: 2021-12-05
• Completion: 2021-12-05
• First posted: 2019-12-19
• Last updated: 2019-12-19

Locations

1 site across 1 country: Italy