Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04205058
Status:
UNKNOWN
Last Update Posted:
2019-12-19
First Post:
2019-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coffee After Pancreatic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060766', 'term': 'Drinking Water'}], 'ancestors': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are masked about the type of coffee administrated (standard coffee versus caffeine-free coffee). Masking about administration of hot water is not feasible.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomised placebo-controlled single blinded trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 199}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First Bowel Movement', 'timeFrame': '96 hours.', 'description': 'Time to first bowel movement (expressed by hours from the time of surgical procedure ending).'}], 'secondaryOutcomes': [{'measure': 'First Flatus', 'timeFrame': '96 hours', 'description': 'Time to first flatus (expressed by hours from the time of surgical procedure ending).'}, {'measure': 'Tolerance to solid food', 'timeFrame': '96 hours', '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.'}, {'measure': 'Length of stay', 'timeFrame': '90 days', 'description': 'Length of stay expressed by days from intervention to discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomised clinical trial', 'Pancreatic surgery'], 'conditions': ['Postoperative Ileus', 'Postoperative Complications', 'Bowel Dysfunction', 'Pancreatic Diseases']}, 'referencesModule': {'references': [{'pmid': '23079762', 'type': 'BACKGROUND', '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.'}, {'pmid': '23377782', 'type': 'BACKGROUND', '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.'}, {'pmid': '18305994', 'type': 'BACKGROUND', '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.'}, {'pmid': '19590205', 'type': 'BACKGROUND', '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.'}, {'pmid': '20113944', 'type': 'BACKGROUND', '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.'}, {'pmid': '22987303', 'type': 'BACKGROUND', '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.'}, {'pmid': '26445179', 'type': 'BACKGROUND', '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.'}, {'pmid': '27780709', 'type': 'BACKGROUND', '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.'}, {'pmid': '30998528', 'type': 'BACKGROUND', '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.'}, {'pmid': '20622661', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective open pancreaticoduodenectomy\n* Age ≥ 18 years\n* American Society Anesthesiologists (ASA) score ≤ 3\n* Ability of the subject to understand aims and clinical consequences of the trial\n* Written informed consent\n\nExclusion Criteria:\n\n* American Society Anesthesiologists (ASA) score ≥ 4\n* Need for early postoperative Intensive Care Unit care\n* Need for naso-gastric tube on postoperative day one\n* Intolerance to coffee\n* Refuse to assume coffee\n* Pregnancy\n* Surgical procedures performed different from pancreaticoduodenectomy\n* Impaired mental status or language problems'}, 'identificationModule': {'nctId': 'NCT04205058', 'acronym': 'COPS', 'briefTitle': 'Coffee After Pancreatic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Integrata Verona'}, 'officialTitle': 'Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2296CESC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'standard coffee', '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).', 'interventionNames': ['Dietary Supplement: Standard coffee']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'caffeine-free coffee', '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).', 'interventionNames': ['Dietary Supplement: Caffeine-free coffee']}, {'type': 'SHAM_COMPARATOR', 'label': 'water', 'description': 'Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).', 'interventionNames': ['Dietary Supplement: Drinking water']}], 'interventions': [{'name': 'Standard coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).', 'armGroupLabels': ['standard coffee']}, {'name': 'Caffeine-free coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).', 'armGroupLabels': ['caffeine-free coffee']}, {'name': 'Drinking water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).', 'armGroupLabels': ['water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37124', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Erica Secchettin', 'role': 'CONTACT', 'email': 'erica.secchettin@aovr.veneto.it', 'phone': '+390458126254'}, {'name': 'Claudio Bassi, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOUI Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Fabio Casciani, MD', 'role': 'CONTACT', 'email': 'fabio.casciani01@gmail.com', 'phone': '+39 045 8124553'}, {'name': 'Erica Secchettin', 'role': 'CONTACT', 'email': 'erica.secchettin@aovr.veneto.it', 'phone': '+39 045 8126254'}], 'overallOfficials': [{'name': 'Claudio Bassi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Azienda Ospedaliera Universitaria Integrata Verona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}