Coffee After Pancreatic Surgery

NCT04205058 | Unknown

• 1 other identifier: 2296CESC
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus; Postoperative Complications; Bowel Dysfunction; Pancreatic Diseases

Keywords

Randomised clinical trial; Pancreatic surgery

Outcome Measures

Primary Outcomes (1)

• First Bowel Movement

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

  96 hours.

Secondary Outcomes (3)

• First Flatus

  96 hours

• Tolerance to solid food

  96 hours

• Length of stay

  90 days

Study Arms (3)

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).

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).

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).

Dietary Supplement: Drinking water

Interventions

Standard coffee DIETARY_SUPPLEMENT

One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

standard coffee

Caffeine-free coffee DIETARY_SUPPLEMENT

One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

caffeine-free coffee

Drinking water DIETARY_SUPPLEMENT

One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).

water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona

Verona, 37124, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 23079762 BACKGROUND

• 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.

  PMID: 23377782 BACKGROUND

• 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.

  PMID: 18305994 BACKGROUND

• 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.

  PMID: 19590205 BACKGROUND

• 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.

  PMID: 20113944 BACKGROUND

• 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.

  PMID: 22987303 BACKGROUND

• 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.

  PMID: 26445179 BACKGROUND

• 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.

  PMID: 27780709 BACKGROUND

• 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.

  PMID: 30998528 BACKGROUND

• 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.

  PMID: 20622661 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Intestinal Diseases; Pancreatic Diseases

Interventions

Drinking Water

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Claudio Bassi, MD

  Azienda Ospedaliera Universitaria Integrata Verona

  STUDY DIRECTOR

Central Study Contacts

Fabio Casciani, MD

CONTACT

+39 045 8124553; fabio.casciani01@gmail.com

Erica Secchettin

CONTACT

+39 045 8126254; erica.secchettin@aovr.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked about the type of coffee administrated (standard coffee versus caffeine-free coffee). Masking about administration of hot water is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised placebo-controlled single blinded trial

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 19, 2019
• Study Start: September 5, 2019
• Primary Completion: December 5, 2021
• Study Completion: December 5, 2021
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)