Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-25 @ 6:22 PM
Study NCT ID:
NCT04203602
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2019-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hospital Discharge Following Bariatric Surgery by Telepresence Robot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'non-inferiority randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-16', 'studyFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital discharges by robotic or face-to-face rounds', 'timeFrame': '2 days', 'description': 'number of patients discharged on postoperative day 2 by robotic or face-to-face ward rounds'}], 'secondaryOutcomes': [{'measure': 'contact with team', 'timeFrame': '2 weeks', 'description': 'number of phone calls to the assistant team after discharge and before first visit at the clinic'}, {'measure': 'complications, reoperations, readmissions', 'timeFrame': 'up to 30 days after surgery', 'description': 'rates of early complications, reoperations, readmissions'}, {'measure': "Patients' and team's impressions", 'timeFrame': '2 days', 'description': "compare a validated questionnaire design to access patients' and team's impressions. There are 13 questions with answers valued from 1 to 5. The higher the score, the better the impression. The scores from the two groups are going to be compared in order to determine if patients' and team's impressions are similar with either robotic or face-to-face rounds."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'bariatric surgery'], 'conditions': ['Severe Obesity']}, 'descriptionModule': {'briefSummary': 'This is a non-inferiority randomized controlled trial aimed to compare the effectiveness and feasibility of performing the ward round using a telepresence robot vs. a face-to-face ward round to discharge patients after bariatric surgery.', 'detailedDescription': 'This study is aimed to analyze the effectiveness and feasibility of performing the ward round using a telepresence robot (PadBot U, Inbot Technology Ltd, China), compared to the face-to-face ward round, for hospital discharge after bariatric surgery. Patients who underwent either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy will be randomized to one of two groups: intervention group - who will be evaluated and discharged, on postoperative day (POD) 2, during ward rounds with the assistant team present, but the telepresent surgeon via robot; and control group - who will be evaluated and discharged, on POD 2, during ward rounds with the whole team physically present.\n\nThe study main hypothesis is that the ward rounds with the surgeon telepresent by a robot are not inferior to the face to face ward rounds, to evaluate and discharge patients after bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that underwent bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy\n\nExclusion Criteria:\n\n* complications during surgery; unable to sign informed consent; admitted to ICU; previous foregut surgery.'}, 'identificationModule': {'nctId': 'NCT04203602', 'briefTitle': 'Hospital Discharge Following Bariatric Surgery by Telepresence Robot', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Assessment of Feasibility and Efficacy of Hospital Discharge Following Bariatric Surgery Using a Telepresence Robot: a Non-inferiority Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '25656919.4.0000.5327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telepresence round', 'description': 'Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.', 'interventionNames': ['Procedure: telepresence discharge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional round', 'description': 'Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.', 'interventionNames': ['Other: Conventional discharge']}], 'interventions': [{'name': 'telepresence discharge', 'type': 'PROCEDURE', 'description': 'Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.', 'armGroupLabels': ['Telepresence round']}, {'name': 'Conventional discharge', 'type': 'OTHER', 'description': 'Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.', 'armGroupLabels': ['conventional round']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montenegro', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cacio R Wietzycoski, MD', 'role': 'CONTACT', 'email': 'wiezycoski@hotmail.com', 'phone': '+55(51)991719499'}], 'facility': 'Unimed Vale do Caí', 'geoPoint': {'lat': -29.68861, 'lon': -51.46111}}], 'centralContacts': [{'name': 'Guilherme S Mazzini, MD, PhD', 'role': 'CONTACT', 'email': 'guimazzini@gmail.com', 'phone': '+55(51)982364873'}], 'overallOfficials': [{'name': 'Guilherme S Mazzini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clinicas de Porto Alegre'}, {'name': 'Cacio Wietzycoski, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Unimed Vale do Caí'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guilherme da Silva Mazzini', 'investigatorAffiliation': 'Hospital de Clinicas de Porto Alegre'}}}}