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Coffee After Pancreatic Surgery (COPS)

Primary Purpose

Postoperative Ileus, Postoperative Complications, Bowel Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Standard coffee
Caffeine-free coffee
Drinking water
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring Randomised clinical trial, Pancreatic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AOUI VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

standard coffee

caffeine-free coffee

water

Arm Description

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).

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

Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2019
Last Updated
December 17, 2019
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
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1. Study Identification

Unique Protocol Identification Number
NCT04205058
Brief Title
Coffee After Pancreatic Surgery
Acronym
COPS
Official Title
Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
December 5, 2021 (Anticipated)
Study Completion Date
December 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus, Postoperative Complications, Bowel Dysfunction, Pancreatic Diseases
Keywords
Randomised clinical trial, Pancreatic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised placebo-controlled single blinded trial
Masking
Participant
Masking Description
Participants are masked about the type of coffee administrated (standard coffee versus caffeine-free coffee). Masking about administration of hot water is not feasible.
Allocation
Randomized
Enrollment
199 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard coffee
Arm Type
Experimental
Arm Description
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).
Arm Title
caffeine-free coffee
Arm Type
Placebo Comparator
Arm Description
Hot caffeine-free coffee (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
Arm Title
water
Arm Type
Sham Comparator
Arm Description
Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard coffee
Intervention Description
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine-free coffee
Intervention Description
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
Intervention Type
Dietary Supplement
Intervention Name(s)
Drinking water
Intervention Description
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
Primary Outcome Measure Information:
Title
First Bowel Movement
Description
Time to first bowel movement (expressed by hours from the time of surgical procedure ending).
Time Frame
96 hours.
Secondary Outcome Measure Information:
Title
First Flatus
Description
Time to first flatus (expressed by hours from the time of surgical procedure ending).
Time Frame
96 hours
Title
Tolerance to solid food
Description
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.
Time Frame
96 hours
Title
Length of stay
Description
Length of stay expressed by days from intervention to discharge.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Casciani, MD
Phone
+39 045 8124553
Email
fabio.casciani01@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Secchettin
Phone
+39 045 8126254
Email
erica.secchettin@aovr.veneto.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Bassi, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Study Director
Facility Information:
Facility Name
AOUI Verona
City
Verona
ZIP/Postal Code
37124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Secchettin
Phone
+390458126254
Email
erica.secchettin@aovr.veneto.it
First Name & Middle Initial & Last Name & Degree
Claudio Bassi, Prof

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23079762
Citation
Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; ERAS(R) Society; European Society for Clinical Nutrition and Metabolism; International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26.
Results Reference
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PubMed Identifier
23377782
Citation
Vather R, Trivedi S, Bissett I. Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg. 2013 May;17(5):962-72. doi: 10.1007/s11605-013-2148-y. Epub 2013 Feb 2.
Results Reference
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PubMed Identifier
18305994
Citation
Artinyan A, Nunoo-Mensah JW, Balasubramaniam S, Gauderman J, Essani R, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr. Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg. 2008 Jul;32(7):1495-500. doi: 10.1007/s00268-008-9491-2.
Results Reference
background
PubMed Identifier
19590205
Citation
Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.
Results Reference
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PubMed Identifier
20113944
Citation
Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.
Results Reference
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PubMed Identifier
22987303
Citation
Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.
Results Reference
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PubMed Identifier
26445179
Citation
Dulskas A, Klimovskij M, Vitkauskiene M, Samalavicius NE. Effect of Coffee on the Length of Postoperative Ileus After Elective Laparoscopic Left-Sided Colectomy: A Randomized, Prospective Single-Center Study. Dis Colon Rectum. 2015 Nov;58(11):1064-9. doi: 10.1097/DCR.0000000000000449.
Results Reference
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Citation
Gungorduk K, Ozdemir IA, Gungorduk O, Gulseren V, Gokcu M, Sanci M. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial. Am J Obstet Gynecol. 2017 Feb;216(2):145.e1-145.e7. doi: 10.1016/j.ajog.2016.10.019. Epub 2016 Oct 22.
Results Reference
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Hasler-Gehrer S, Linecker M, Keerl A, Slieker J, Descloux A, Rosenberg R, Seifert B, Nocito A. Does Coffee Intake Reduce Postoperative Ileus After Laparoscopic Elective Colorectal Surgery? A Prospective, Randomized Controlled Study: The Coffee Study. Dis Colon Rectum. 2019 Aug;62(8):997-1004. doi: 10.1097/DCR.0000000000001405.
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Coffee After Pancreatic Surgery

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