Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-27 @ 3:15 PM
Study NCT ID:
NCT03070457
Status:
UNKNOWN
Last Update Posted:
2017-03-03
First Post:
2017-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of an Early Discharge Protocol After Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Readmissions rate', 'timeFrame': '1 month', 'description': 'No hospital admissions after surgery'}], 'secondaryOutcomes': [{'measure': 'Morbidity rate', 'timeFrame': '1 month', 'description': 'Number of postoperative complications'}, {'measure': 'Chronogram for complications after surgery', 'timeFrame': '1 month', 'description': 'Detailed timing of appearance'}, {'measure': 'Quality of life', 'timeFrame': '1 month', 'description': 'BAROS questionnaire'}, {'measure': 'Patients agreement to the protocol', 'timeFrame': '1 month', 'description': 'Specific survey created ad hoc'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'sleeve gastrectomy', 'eras'], 'conditions': ['Morbid Obesity', 'Sleeve Gastrectomy', 'Early Discharge', 'Safety Issues']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.', 'detailedDescription': 'This study aims to demonstrate that a shorter hospital stay after sleeve gastrectomy is as safe and useful as conventional protocol with 48-36 hours of stay. We consider that an adequate patient information and support will facilitate this shorter stay'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients eligible for Sleeve gastrectomy\n* BMI 35 to 50\n* ASA I to III\n* Conventional address close to our Hospital\n* Laparoscopic surgery\n* Accompanying person after discharge\n* Availability for a smart phone\n\nExclusion Criteria:\n\n* ASA IV\n* Revisional Surgery\n* Conversion to laparotomy\n* ICU Admission after surgery\n* Insulin dependent Diabetes Mellitus\n* Surgery finishing after 3 pm'}, 'identificationModule': {'nctId': 'NCT03070457', 'briefTitle': 'Safety of an Early Discharge Protocol After Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'AC007/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early discharge group', 'description': 'Patients with a shorter hospital stay, 23 hours after surgery', 'interventionNames': ['Other: Early discharge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional discharge', 'description': 'Patients with conventional protocol and 48-72 hours of hospital stay', 'interventionNames': ['Other: Conventional protocol']}], 'interventions': [{'name': 'Early discharge', 'type': 'OTHER', 'description': 'Patients randomised to early discharge or not', 'armGroupLabels': ['Early discharge group']}, {'name': 'Conventional protocol', 'type': 'OTHER', 'description': 'Discharge as usually done 48-72 hours after surgery', 'armGroupLabels': ['Conventional discharge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Amador Garcia Ruiz de Gordejuela, MD, PhD', 'role': 'CONTACT', 'email': 'agrgordejuela@bellvitgehospital.cat', 'phone': '+35932607621'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Amador Garci-a Ruiz de Gordejuela', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}