Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02415335
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mobilisation postoperative (Ability to get out of bed)', 'timeFrame': '2-10 hours postoperative', 'description': 'Ability to get out of bed'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': '2-10 hours postoperative', 'description': 'Localization of postoperative pain'}, {'measure': 'Adverse events', 'timeFrame': '30 days', 'description': 'AE, AR, SAR and SUSARS'}, {'measure': 'Mobilisation postoperative (Ability to get out of bed)', 'timeFrame': '8-16 hours postoperative', 'description': 'Ability to get out of bed'}, {'measure': 'Mobilisation postoperative (Ability to get out of bed)', 'timeFrame': '24-32 hours postoperative', 'description': 'Ability to get out of bed'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': '8-16 hours postoperative', 'description': 'Localization of postoperative pain'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': '24-32 hours postoperative', 'description': 'Localization of postoperative pain'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': 'POD2', 'description': 'Localization of postoperative pain'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': 'POD3', 'description': 'Localization of postoperative pain'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': 'POD7', 'description': 'Localization of postoperative pain'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': 'POD14', 'description': 'Localization of postoperative pain'}, {'measure': 'Pain localization (Localization of postoperative pain)', 'timeFrame': 'POD30', 'description': 'Localization of postoperative pain'}], 'primaryOutcomes': [{'measure': 'Postoperative nausea and vomiting (PONV)', 'timeFrame': '24-32 hours postoperative', 'description': 'Incidents of nausea and/or vomiting during the first 24-32 hours postoperative'}], 'secondaryOutcomes': [{'measure': 'Pain at rest (VAS scale)', 'timeFrame': '2-10 hours postoperative', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': '2-10 hours postoperative', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale)', 'timeFrame': '2-10 hours postoperative', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Quality of recovery (QoR-15D questionnaire)', 'timeFrame': '24-32 hours postoperative', 'description': 'Quality of recovery measured by the QoR-15D questionnaire'}, {'measure': 'Time until resumption of normal daily activities', 'timeFrame': 'Registration when resumption, expected to be within 60 days postoperatively', 'description': 'Time until resumption of normal daily activities and reason for not resuming activities earlier'}, {'measure': 'Time until resumption of work', 'timeFrame': 'Registration when resumption, expected to be within 60 days postoperatively', 'description': 'Time until resumption of work and reason for not resuming work earlier'}, {'measure': 'Sleep quality (VAS scale)', 'timeFrame': '24-32 hours postoperative', 'description': 'Quality of sleep measured on a 100 mm VAS scale'}, {'measure': 'Postoperative complications (Clavien-Dindo classification of surgical complications)', 'timeFrame': '30 days postoperative', 'description': '30 days postoperative complication according to the Clavien-Dindo classification of surgical complications'}, {'measure': 'Duration of admission', 'timeFrame': '30 days', 'description': 'Duration of primary admission'}, {'measure': 'PONV', 'timeFrame': '2-10 hours postoperatively'}, {'measure': 'PONV', 'timeFrame': '8-16 hours postoperatively'}, {'measure': 'PONV', 'timeFrame': '24-32 hours postoperatively'}, {'measure': 'Pain at rest (VAS scale)', 'timeFrame': '8-16 hours postoperative', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain at rest (VAS scale)', 'timeFrame': '24-32 hours postoperative', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain at rest (VAS scale)', 'timeFrame': 'POD (Post Operative Day) 2', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain at rest (VAS scale)', 'timeFrame': 'POD3', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain at rest (VAS scale)', 'timeFrame': 'POD7', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain at rest (VAS scale)', 'timeFrame': 'POD14', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain at rest (VAS scale)', 'timeFrame': 'POD30', 'description': 'Pain at rest measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': '8-16 hours postoperative', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': '24-42 hours postoperative', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': 'POD2', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': 'POD3', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': 'POD7', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': 'POD14', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Pain when coughing (VAS scale)', 'timeFrame': 'POD30', 'description': 'Pain when coughing measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale)', 'timeFrame': '8-16 hours postoperative', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale', 'timeFrame': '24-32 hours postoperative', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale', 'timeFrame': 'POD2', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale', 'timeFrame': 'POD3', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale', 'timeFrame': 'POD7', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale', 'timeFrame': 'POD14', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Postoperative fatigue (VAS scale', 'timeFrame': 'POD30', 'description': 'Postoperative fatigue measured on a 100 mm VAS scale'}, {'measure': 'Quality of recovery (QoR-15D questionnaire)', 'timeFrame': 'POD2', 'description': 'Quality of recovery measured by the QoR-15D questionnaire'}, {'measure': 'Quality of recovery (QoR-15D questionnaire)', 'timeFrame': 'POD3', 'description': 'Quality of recovery measured by the QoR-15D questionnaire'}, {'measure': 'Quality of recovery (QoR-15D questionnaire)', 'timeFrame': 'POD7', 'description': 'Quality of recovery measured by the QoR-15D questionnaire'}, {'measure': 'Quality of recovery (QoR-15D questionnaire)', 'timeFrame': 'POD14', 'description': 'Quality of recovery measured by the QoR-15D questionnaire'}, {'measure': 'Quality of recovery (QoR-15D questionnaire)', 'timeFrame': 'POD30', 'description': 'Quality of recovery measured by the QoR-15D questionnaire'}, {'measure': 'Sleep quality (VAS scale)', 'timeFrame': 'POD2', 'description': 'Quality of sleep measured on a 100 mm VAS scale'}, {'measure': 'Sleep quality (VAS scale)', 'timeFrame': 'POD3', 'description': 'Quality of sleep measured on a 100 mm VAS scale'}, {'measure': 'Sleep quality (VAS scale)', 'timeFrame': 'POD7', 'description': 'Quality of sleep measured on a 100 mm VAS scale'}, {'measure': 'Sleep quality (VAS scale)', 'timeFrame': 'POD14', 'description': 'Quality of sleep measured on a 100 mm VAS scale'}, {'measure': 'Sleep quality (VAS scale)', 'timeFrame': 'POD30', 'description': 'Quality of sleep measured on a 100 mm VAS scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Suspected Appendicitis']}, 'referencesModule': {'references': [{'pmid': '29605019', 'type': 'DERIVED', 'citation': 'Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.'}, {'pmid': '28072446', 'type': 'DERIVED', 'citation': 'Kleif J, Kirkegaard A, Vilandt J, Gogenur I. Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis. Br J Surg. 2017 Mar;104(4):384-392. doi: 10.1002/bjs.10418. Epub 2017 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of 8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been established. The investigators wish to see if preoperative administration of 8 mg dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative fatigue, duration of time until resumption of work and resumption of normal daily activities, and enhanced the quality of recovery.', 'detailedDescription': 'Eligible patients undergoing a diagnostic laparoscopy for suspected appendicitis will be randomized to receive placebo or 8 mg dexamethasone intravenously minimum 30 minutes prior to the operation.\n\nRandomization will be done by envelope randomization. We would expect that 60% of the patients would experience postoperative nausea or vomiting (PONV) during the first 24-32 hours postoperatively. To show a 50% reduction in the incidents of PONV during the first 24-32 hours postoperatively (with a power of 80%, a significant level of 5% and a loss to follow up of 20%) we need 60 patients in each arm. So a total of 120 patients are to be randomized 1:1.\n\nBoth sites use paper Case Report Forms (CRF). The trial will be monitored by the regional GCP (Good Clinical Practice) unit and adhere to GCP guidelines.\n\nPatients are assessed by self reporting questionnaires preoperatively and postoperatively after 2-10 hours, 8-16 hours, 24-32 hours, on postoperative day (POD) 2, POD 3, POD 7, POD 14 and POD 30.\n\nPreoperative anxiety recorded by a VAS scale, Pain Catastrophizing Scale and Hospital anxiety and depression scale are recorded by the preoperative questionnaire.\n\nA short telephone interview will be done during the first postoperative day regarding duration of abdominal pain prior to admission, social status regarding children and whether they living with another adult, smoking status, use of sleep medication or use of psychopharmacy a minimum of 7 days prior to the operation, physical level of normal daily activities, physical level of work, educational and occupational background.\n\nOther demographics such as height, weight, ASA class, age, last CRP prior to the operation, duration of the operation, date and time of admission, date and time of discharge are registered through the electronic patient record files. Pathology of any removed tissue are registered trough the pathology report.\n\nDiagnosis at the operation, preformed procedure, whether the preforming surgeon was supervised, number of identical procedures preformed previous by the surgeon or the surgeons supervisor (if supervised) will be recorded in the patients CRF by the preforming surgeon.\n\nPre-, intra- and post-operative pain medication, antiemetics and antibiotics are recorded through the electronic patient medication files.\n\nPostoperative complications and adverse events are recorded through the electronic patient record files and by telephone interview.\n\nTo ensure a high completion rate, patients are contacted by telephone at each registration time postoperatively.\n\nParametric or non-parametric statistical analysis will be used when appropriate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled for a diagnostic laparoscopy for suspected appendicitis\n* ASA clas I-III\n\nExclusion Criteria:\n\n* Known inflammatory bowel disease\n* Known autoimmune disease.\n* Chronic pain patient.\n* Pregnant or breastfeeding.\n* In treatment with systemic corticoid steroids or immune-depressants.\n* Known glaucoma.\n* Known ocular herpes simplex.\n* Vaccination within 14 days prior to inclusion.\n* Known cushing's disease.\n* Known myasthenia gravis.\n* Presumably poor compliance with study protocol."}, 'identificationModule': {'nctId': 'NCT02415335', 'briefTitle': 'Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis', 'orgStudyIdInfo': {'id': '2014-707'}, 'secondaryIdInfos': [{'id': '2014-005040-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Injection of 2 ml isotonic NaCl intravenously minimum 30 minutes preoperative.', 'interventionNames': ['Drug: Isotonic NaCl']}, {'type': 'EXPERIMENTAL', 'label': 'dexamethasone', 'description': 'Injection of 2 ml 4 mg/ml dexamethasone phosphate intravenously minimum 30 minutes preoperative.', 'interventionNames': ['Drug: dexamethasone phosphate']}], 'interventions': [{'name': 'dexamethasone phosphate', 'type': 'DRUG', 'otherNames': ['Dexamethasone'], 'description': 'Intravenously administration minimum of 30 minutes preoperatively.', 'armGroupLabels': ['dexamethasone']}, {'name': 'Isotonic NaCl', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Intravenously administration minimum of 30 minutes preoperatively', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Kirurgisk afdeling, Nordsjællands Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Kirurgisk afdeling, Køge sygehus', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Jakob Kleif, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nordsjaellands Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zealand University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}