Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT03429205
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2018-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of External Warming During Laparoscopic Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Recruiting pace too slow.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2018-02-04', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative core-temperature decline', 'timeFrame': 'Surgery duration, up to 2 hours from surgery start-time', 'description': 'Core-temperature will be continuously measured throughout surgery'}, {'measure': 'Arrival temperature at post anesthesia care unit (PACU)', 'timeFrame': 'arrival to recovery room, up to 2 h from surgery start-time', 'description': 'Core temperature upon arrival to recovery room'}], 'secondaryOutcomes': [{'measure': 'Hypothermia events', 'timeFrame': '3 hours from surgery start-time', 'description': 'Measurement of core temperature \\<35 C'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'Surgery duration, up to 2 hours from surgery start-time', 'description': 'Intraoperative bleeding score will be used'}, {'measure': 'Post operative complications', 'timeFrame': '30 days postoperatively', 'description': 'Complications after surgery (30 days), graded according to Clavien-Dindo classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleeve gastrectomy', 'Roux-Y gastric bypass', 'Single anastomosis gastric bypass', 'Hypothermia', 'External heating blanket'], 'conditions': ['Hypothermia', 'Morbid Obesity', 'Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': 'External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump.\n\nThe need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered.\n\nThe study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last \\<2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for bariatric surgery\n* Surgery time estimated to be \\< 2 hours\n\nExclusion Criteria:\n\n* Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).\n* Surgery time estimated to be more than 2 hours'}, 'identificationModule': {'nctId': 'NCT03429205', 'briefTitle': 'The Efficacy of External Warming During Laparoscopic Bariatric Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Efficacy of External Warming During Laparoscopic Bariatric Surgery', 'orgStudyIdInfo': {'id': '4578-17-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No heating - Study group', 'description': 'Patient will undergo bariatric surgery without utilization of external heating device.', 'interventionNames': ['Other: No external heating used during surgery']}, {'type': 'OTHER', 'label': 'Heating - Control group', 'description': 'Patient will undergo bariatric surgery with utilization of external heating device.', 'interventionNames': ['Other: External heating blanket used during surgery']}], 'interventions': [{'name': 'No external heating used during surgery', 'type': 'OTHER', 'description': 'Deviation from external heating for all surgery standard', 'armGroupLabels': ['No heating - Study group']}, {'name': 'External heating blanket used during surgery', 'type': 'OTHER', 'description': 'Standard external heating plan used in all surgery types', 'armGroupLabels': ['Heating - Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56261', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Bariatric and Metabolic Surgery, Principal Investigator', 'investigatorFullName': 'David Goitein MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}