Coffee After Pancreatic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2021-12-05

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.

Conditions

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Postoperative Ileus Postoperative Complications Bowel Dysfunction Pancreatic Diseases

Keywords

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Randomised clinical trial Pancreatic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised placebo-controlled single blinded trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants are masked about the type of coffee administrated (standard coffee versus caffeine-free coffee). Masking about administration of hot water is not feasible.

Study Groups

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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).

Group Type EXPERIMENTAL