Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04205058
Other study ID # 2296CESC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT02565420 - Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Not yet recruiting NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy N/A
Not yet recruiting NCT05052021 - The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study
Not yet recruiting NCT03591432 - A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia. N/A
Not yet recruiting NCT03639012 - Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy N/A
Not yet recruiting NCT03275324 - Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients N/A
Recruiting NCT02763878 - Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy Phase 3
Completed NCT02891187 - Visits Versus Telephone Calls for Postoperative Care N/A
Completed NCT02947789 - Predictive Model for Postoperative Mortality N/A
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02766062 - Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Enrolling by invitation NCT01744938 - Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice Phase 3
Completed NCT02265991 - Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation N/A