Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-31 @ 6:03 AM
Study NCT ID:
NCT01629992
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2012-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Counseling in Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale', 'timeFrame': '24h after operation', 'description': 'A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked.'}], 'secondaryOutcomes': [{'measure': 'Episodes of vomiting', 'timeFrame': 'During the first 24h after surgery', 'description': 'Number of episodes of vomiting occurring until 24h after the operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vomiting', 'Nausea', 'Postoperative pain', 'Feeling'], 'conditions': ['Vomiting', 'Nausea', 'Postoperative Pain', 'Feeling']}, 'descriptionModule': {'briefSummary': 'The investigators examined whether a written plus verbal preoperative counseling for patients undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting and pain.', 'detailedDescription': 'This was a randomized, single-blinded, clinical study carried out at the Julio Muller University Hospital (Mato Grosso State, Brazil). This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving human subjects/patients were approved by the hospital Research Ethics Committee registered under number 697/CEP-HUJM/09. Written informed consent was obtained from all patients.\n\nExcept for the preoperative counseling which was received only by the intervention group, all patients received the same protocol of perioperative care.\n\nThe main endpoint of the study was the presence and the intensity of postoperative symptoms such as nausea, vomiting and pain. A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked. The questions were: "how severe was your pain during this period of 24h after the operation?", "how severe was the intensity of your nausea during this period of 24h after the operation? ", and "how great is your well-being at the present moment". For the first two questions the words at each end of the line were "no pain" and "severe pain", and "no nausea" and "severe nausea". For the well-being question the words were "no well-being" and "greatest well-being". The Vomiting was also recorded as a categorical variable (yes or no). The length of stay and postoperative complications were also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult age (18-65 years-old),\n* both sexes and\n* candidates for an elective open cholecystectomy\n\nExclusion Criteria:\n\n* having diabetes mellitus,\n* chronic kidney failure,\n* chronic liver disease,\n* serum bilirubin \\> 2 mg/dL,\n* body mass index (BMI) \\> 35 kg/m2,\n* American Anesthesiologists Association (ASA) score \\> 3,\n* gastro-esophageal reflux,\n* gastroparesis or intestinal obstruction.\n\nPatients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (\\> 4 h) operative time were also excluded.'}, 'identificationModule': {'nctId': 'NCT01629992', 'briefTitle': 'Preoperative Counseling in Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Mato Grosso'}, 'officialTitle': 'Preoperative Counseling in Cholecystectomy. A Randomized Trial', 'orgStudyIdInfo': {'id': 'preopcounseling'}, 'secondaryIdInfos': [{'id': '697/CEP-HUJM/09', 'type': 'OTHER', 'domain': 'HUJM Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative counseling', 'description': 'The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.', 'interventionNames': ['Other: Preoperative counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group received no preoperative counseling either oral or written.'}], 'interventions': [{'name': 'Preoperative counseling', 'type': 'OTHER', 'otherNames': ['Preoperative information'], 'description': 'The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.', 'armGroupLabels': ['Preoperative counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000-000', 'city': 'Cuiabá', 'state': 'Mato Grosso', 'country': 'Brazil', 'facility': 'Hospital Universitario Julio Mullar', 'geoPoint': {'lat': -15.59611, 'lon': -56.09667}}], 'overallOfficials': [{'name': 'Jose Aguilar-Nascimento, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Mato Grosso'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Mato Grosso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Professor', 'investigatorFullName': 'Jose Eduardo de Aguilar-Nascimento', 'investigatorAffiliation': 'Federal University of Mato Grosso'}}}}