Coffee After Pancreatic Surgery

Postoperative Complications Clinical Trial

— COPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205058
• Other study ID #: 2296CESC
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: December 5, 2021

Study information

• Verified date: December 2019
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Fabio Casciani, MD
• Phone: +39 045 8124553
• Email: fabio.casciani01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 199
• Est. completion date: December 5, 2021
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Standard coffee
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
• Caffeine-free coffee
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
• Drinking water
One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

Locations

Country	Name	City	State
Italy	AOUI Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View 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. — View Citation

Bassi 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. — View 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. — View Citation

Güngördük K, Özdemir IA, Güngördük Ö, Gülseren V, Gokçü 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. — View Citation

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. — View Citation

Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schäfer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; ERAS® 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®) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26. — View Citation

Müller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Büchler 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Bowel Movement	Time to first bowel movement (expressed by hours from the time of surgical procedure ending).	96 hours.
Secondary	First Flatus	Time to first flatus (expressed by hours from the time of surgical procedure ending).	96 hours
Secondary	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
Secondary	Length of stay	Length of stay expressed by days from intervention to discharge.	90 days