Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 10:43 AM
Study NCT ID:
NCT04546594
Status:
WITHDRAWN
Last Update Posted:
2025-12-23
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Data on Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'LACK OF RESOURCES', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Descriptive analysis of the typology of pain in patients needing surgery.', 'timeFrame': 'Baseline', 'description': 'The typology of pain will be analyzed on the basis of responses to questionnaires on the affective and sensory dimension of pain, quality of life, depression, anxiety and catastrophizing'}], 'secondaryOutcomes': [{'measure': 'Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery.', 'timeFrame': 'follow-up over a period of five years during post-operative or pain medical consultation', 'description': 'Describe the specific symptomatology of pain separately according to the 3 pathologies: patients needing orthopedic, thoracic and gynecological surgery.'}, {'measure': 'Pain Catastrophizing Scale (PCS) according to pain', 'timeFrame': 'Baseline and follow-up over a period of five years during post-operative or pain medical consultation'}, {'measure': 'Hospital Anxiety Depression scale (HAD) according to pain', 'timeFrame': 'Baseline and follow-up over a period of five years during post-operative or pain medical consultation'}, {'measure': 'EQD5 according to pain', 'timeFrame': 'Baseline and follow-up over a period of five years during post-operative or pain medical consultation'}, {'measure': 'Identification of factors predictive of acute or chronic pain.', 'timeFrame': 'Baseline and at three months, six months, one year', 'description': 'The presence of pain will be defined by the presence of severe pain and/or the presence of neuropathic pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain,', 'perioperative pain', 'epidemiology', 'predictive factors'], 'conditions': ['Orthopedic Disorder', 'Thoracic', 'Gynecological; Surgery (Previous), Causing Obstructed Labor, Affecting Fetus', 'Pain']}, 'descriptionModule': {'briefSummary': 'The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients consulting at the university hospital of Lille and needing orthopedic, thoracic, gynecological surgical management with or without painful symptoms and chronic painful patients in the context of organ pathologies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 17 years old Patient needing orthopedic surgery Patient needing gynecological surgery Patient needing thoracic surgery Patient who has given written consent to participate in the trial. Socially insured patient Patient willing to comply with all study procedures and study duration\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Non-communicating patient\n* Patient does not understand French\n* Patient without social protection\n* Patient refusing to participate'}, 'identificationModule': {'nctId': 'NCT04546594', 'acronym': 'ALGOBASES', 'briefTitle': 'Epidemiological Data on Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Collection of Epidemiological Data on Pain Related to Orthopedic, Thoracic or Gynecological Surgery', 'orgStudyIdInfo': {'id': 'RNI_2018_76'}, 'secondaryIdInfos': [{'id': '2020-A01112-37', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orthopedic surgery'}, {'label': 'Thoracic surgery'}, {'label': 'Gynecological surgery'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean-Michel Wattier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}