Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06981793
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2025-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors of Anesthesia Complications in Patients Undergoing Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Anesthesia-Related Complications in Bariatric Surgery Patients', 'timeFrame': 'October 2023 - January 2024', 'description': 'The primary outcome of this study is to assess the occurrence of anesthesia-related complications in patients undergoing bariatric surgery, specifically sleeve gastrectomy. These complications include difficult intubation, bronchospasm, desaturation, abnormal heart rate (bradycardia or tachycardia), changes in blood pressure (hypotension or hypertension), nausea and vomiting, hypo or hyperglycemia, delayed awakening, and death. This measure will help identify factors that predict the likelihood of these complications, ultimately improving patient safety in bariatric surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery', 'Anesthesia, General', 'Postoperative Complications', 'Obesity', 'Risk Factors']}, 'descriptionModule': {'briefSummary': 'This study aims to identify factors that can predict complications related to anesthesia in patients undergoing weight-loss surgery. By looking at patient data from past surgeries, we hope to better understand which factors increase the risk of anesthesia problems, helping doctors improve patient safety during these procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study participants will be selected from adult patients who underwent sleeve gastrectomy as part of bariatric surgery at the Gonesse Hospital (CHG) between January 1, 2020, and June 30, 2021.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Patients who underwent a longitudinal gastrectomy (sleeve) between January 1, 2020, and June 30, 2021, at CHG, as part of bariatric surgery treatment.\n\nExclusion Criteria:\n\n* Minor patients\n* Patients who underwent a bariatric surgery other than sleeve gastrectomy\n* Patients who objected to the use of their data for research purposes'}, 'identificationModule': {'nctId': 'NCT06981793', 'briefTitle': 'Predictors of Anesthesia Complications in Patients Undergoing Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Gonesse'}, 'officialTitle': 'Predictors of Anesthesia Complications in Patients Undergoing Bariatric Surgery', 'orgStudyIdInfo': {'id': '0050_ANESTHESIE'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gonesse', 'state': 'France', 'country': 'France', 'facility': 'France', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Gonesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}