Postoperative IleusCOPSNCT04205058
Coffee After Pancreatic Surgery
A study testing Standard coffee, Caffeine-free coffee and Drinking water in people with Postoperative Ileus and Postoperative Complications, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Postoperative Complications, Bowel Dysfunction
- What is being tested?
- Standard coffee, Caffeine-free coffee and Drinking water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2020to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial
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.
Read the 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.
- Being tested
- Standard coffee, Caffeine-free coffee, Drinking water
- Keywords
- Randomised clinical trial, Pancreatic surgery
- Medical subject headings
- Postoperative Complications, Intestinal Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard coffeeDietary supplement
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
Caffeine-free coffeeDietary supplement
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
Drinking waterDietary supplement
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
| Study group | Role | What they receive |
|---|---|---|
| standard coffee | Experimental | 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). Receives: Dietary Supplement: Standard coffee |
| caffeine-free coffee | Placebo comparator | Hot caffeine-free coffee (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three). Receives: Dietary Supplement: Caffeine-free coffee |
| water | Sham comparator | Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three). Receives: Dietary Supplement: Drinking water |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Bowel Movement
Time to first bowel movement (expressed by hours from the time of surgical procedure ending).
Measured: 96 hours.
Secondary outcomes (3)
First Flatus
Time to first flatus (expressed by hours from the time of surgical procedure ending).
Measured: 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.
Measured: 96 hours
Length of stay
Length of stay expressed by days from intervention to discharge.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start5 Jan 2020
- Primary completion5 Jan 2025
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised, partilly blinded trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Malleo, MD PhD, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205058
- Sponsor's protocol ID
- 2296CESC
- Acronym
- COPS
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2019
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23079762Vather 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.
PubMed 23377782Artinyan 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.
PubMed 18305994Story 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.
PubMed 19590205Asgeirsson 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.
PubMed 20113944Muller 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.
PubMed 22987303Dulskas 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.
PubMed 26445179Gungorduk 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.
PubMed 27780709Hasler-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.
PubMed 30998528Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.
PubMed 20622661
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04205058
- Acronym / sponsor ID
- COPS / 2296CESC
- Keywords
- Randomised clinical trial, Pancreatic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- randomised, partilly blinded trial
| Arm | Type | Receives |
|---|---|---|
| standard coffee | Experimental | Dietary Supplement: Standard coffeeHot standard coffee with caffeine (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three). |
| caffeine-free coffee | Placebo comparator | Dietary Supplement: Caffeine-free coffeeHot caffeine-free coffee (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three). |
| water | Sham comparator | Dietary Supplement: Drinking waterHot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard coffeeOne 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.). | Dietary supplement | standard coffee |
| Caffeine-free coffeeOne 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.). | Dietary supplement | caffeine-free coffee |
| Drinking waterOne 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.). | Dietary supplement | water |
Primary outcome
First Bowel Movement
Time frame: 96 hours.
Time to first bowel movement (expressed by hours from the time of surgical procedure ending).
3 secondary outcomes
First Flatus
Time frame: 96 hours
Tolerance to solid food
Time frame: 96 hours
Length of stay
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 23079762Lassen 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.
- Background: PubMed 23377782Vather 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.
- Background: PubMed 18305994Artinyan 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.
- Background: PubMed 19590205Story 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.
- Background: PubMed 20113944Asgeirsson 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.
- Background: PubMed 22987303Muller 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.
- Background: PubMed 26445179Dulskas 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.
- Background: PubMed 27780709Gungorduk 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.
- Background: PubMed 30998528Hasler-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.
- Background: PubMed 20622661Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.
- Individual participant dataSharing planned: No
Related trials for Postoperative Ileus
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Not yet recruitingPhase 2
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
Delay in GI Recovery/Postoperative Ileus (POI)
Not yet recruiting
Intraperitoneal Saline Irrigation in Cesarean Section
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Malleo, MD PhD principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard coffee, Caffeine-free coffee and Drinking water in people with Postoperative Ileus and Postoperative Complications, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Bowel Movement (time frame: 96 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205058, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.