Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06980402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2025-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-discharge Monitoring Initiative on Outcomes of Post-surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018784', 'term': 'Abdominal Abscess'}, {'id': 'D008100', 'term': 'Liver Abscess'}], 'ancestors': [{'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-05-12', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bed days saved', 'timeFrame': 'From enrollment to 30 days after patient is discharged from the hospital/ post-discharge monitoring programme', 'description': 'Bed days saved in the acute hospital setting'}, {'measure': 'Return to hospital', 'timeFrame': 'From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care', 'description': 'Unplanned readmission/ return to the hospital within 30-days'}, {'measure': 'Length of stay', 'timeFrame': 'From enrollment until patient is discharged from the hospital/ from post-discharge monitoring care (up to around 2 weeks), whichever is longer', 'description': 'Combined length of stay. For inpatients, will be time of admission till time of discharge from acute hospital For patients enrolled into post-discharge monitoring programme, will be from time of admission till time of discharge from post-discharge monitoring programme'}, {'measure': 'Hospitalisation bill', 'timeFrame': 'From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care', 'description': 'Total non-subsidised hospitalisation bill size'}, {'measure': 'Postoperative complications', 'timeFrame': 'From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care', 'description': '30-day postoperative complications, graded by the Clavien-Dindo classification'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Laparoscopic surgery', 'Abdominal abscesses', 'Liver abscesses', 'Discharge planning'], 'conditions': ['Laparoscopy', 'Discharge Planning']}, 'referencesModule': {'references': [{'pmid': '34593374', 'type': 'RESULT', 'citation': "McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Ouellette C, Bird M, Ofori S, Roshanov PS, Patel A, Yang H, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Conen D, Harvey V, Lounsbury J, Mian R, Bangdiwala SI, Arellano R, Scott T, Guyatt GH, Gao P, Graham M, Nenshi R, Forster AJ, Nagappa M, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Harlock J, Meyer RM, Taylor DA, Shanthanna H, Schlachta CM, Parry N, Pichora DR, Yousuf H, Peter E, Lamy A, Petch J, Moloo H, Sehmbi H, Waggott M, Shelley J, Belley-Cote EP, Devereaux PJ; PVC-RAM-1 Investigators. Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209. doi: 10.1136/bmj.n2209."}, {'pmid': '27016900', 'type': 'RESULT', 'citation': 'Gunter RL, Chouinard S, Fernandes-Taylor S, Wiseman JT, Clarkson S, Bennett K, Greenberg CC, Kent KC. Current Use of Telemedicine for Post-Discharge Surgical Care: A Systematic Review. J Am Coll Surg. 2016 May;222(5):915-27. doi: 10.1016/j.jamcollsurg.2016.01.062. Epub 2016 Feb 13. No abstract available.'}, {'pmid': '33641013', 'type': 'RESULT', 'citation': 'Jonker LT, Lahr MMH, Oonk MHM, de Bock GH, van Leeuwen BL. Post-discharge Telemonitoring of Physical Activity, Vital Signs, and Patient-Reported Symptoms in Older Patients Undergoing Cancer Surgery. Ann Surg Oncol. 2021 Oct;28(11):6512-6522. doi: 10.1245/s10434-021-09707-3. Epub 2021 Feb 27.'}, {'pmid': '36812167', 'type': 'RESULT', 'citation': 'van Ede ES, Scheerhoorn J, Buise MP, Bouwman RA, Nienhuijs SW. Telemonitoring for perioperative care of outpatient bariatric surgery: Preference-based randomized clinical trial. PLoS One. 2023 Feb 22;18(2):e0281992. doi: 10.1371/journal.pone.0281992. eCollection 2023.'}, {'pmid': '39028346', 'type': 'RESULT', 'citation': 'Cooper S, Patel S, Wynn M, Provost D, Hassan M. Outcomes of same-day discharge in bariatric surgery. Surg Endosc. 2024 Sep;38(9):5122-5129. doi: 10.1007/s00464-024-11053-w. Epub 2024 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a prospective study to evaluate the SKH@Home programme, a post-discharge monitoring initiative for surgical patients. The aim of this study is to conduct a pragmatic, non-randomized pilot study to compare the SKH@Home programme with standard post-surgical care on patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is keen for home management\n2. Hemodynamically stable\n3. Able and willing to self-care and monitor / Good social support\n4. Lives in Singapore's Northeast region\n\n EITHER\n5. Diagnosed with intra-abdominal abscess requiring ongoing IV antibiotics as recommended by Infectious Diseases Specialist where necessary OR Diagnosed with liver abscess requiring ongoing IV antibiotics as recommended by Infectious Diseases Specialist where necessary AND Has undergone initial treatment (e.g., drainage if required) and is clinically improving\n\n OR\n6. Underwent an uneventful straightforward bariatric surgical procedure, and has been monitored overnight without any immediate postoperative issues OR Underwent uneventful straightforward laparoscopic/ endoscopic/ minimally invasive surgery, and has been monitored for at least 6 hours without any immediate postoperative issues AND has no significant intraprocedural concerns by the operating surgeon\n\nExclusion Criteria:\n\n1. Unable to self-care / no caregiver\n2. Requires daily review by the surgical team\n3. Suspicion of surgical complications requiring surgical intervention\n4. Requires post-discharge monitoring care for \\> 2 weeks\n5. Unregulated psychiatric disorders\n6. Daily flushing of drains required"}, 'identificationModule': {'nctId': 'NCT06980402', 'acronym': 'SKH@home', 'briefTitle': 'Post-discharge Monitoring Initiative on Outcomes of Post-surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sengkang General Hospital'}, 'officialTitle': 'Pragmatic Pilot Study of SKH@Home Post-discharge Monitoring Initiative on Outcomes of Surgical Patients', 'orgStudyIdInfo': {'id': '2024-4580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard inpatient care until deemed suitable for discharge', 'description': 'Post-surgical patients are routinely monitored in the acute hospital setting, until they are deemed suitable for discharge by their primary surgeon.', 'interventionNames': ['Procedure: Standard inpatient care until deemed suitable for discharge']}, {'type': 'EXPERIMENTAL', 'label': 'Early post-surgical discharge with post-surgical home based monitoring', 'description': "The SKH@home program, is a post-discharge monitoring program, which allows stable post-surgical patients (after minimally invasive/ endoscopic/ bariatric surgery) or with stable surgical conditions after interventions (like abdominal or liver abscess management) to be discharged earlier from the acute hospital while providing regular post-discharge monitoring at the patient's own home, either through home visits or patient assessment via telemonitoring.", 'interventionNames': ['Procedure: Early post-surgical discharge with post-surgical home based monitoring']}], 'interventions': [{'name': 'Early post-surgical discharge with post-surgical home based monitoring', 'type': 'PROCEDURE', 'description': "The SKH@home program, is a post-discharge monitoring program, which allows stable post-surgical patients to be discharged earlier from hospital while providing regular post-discharge monitoring at the patient's own home, either through home visits and patient assessment, or telemonitoring of patients.", 'armGroupLabels': ['Early post-surgical discharge with post-surgical home based monitoring']}, {'name': 'Standard inpatient care until deemed suitable for discharge', 'type': 'PROCEDURE', 'description': 'Patients will receive standard postoperative management in the acute hospital until they are deemed fit for discharge by their primary surgeon', 'armGroupLabels': ['Standard inpatient care until deemed suitable for discharge']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chui Kwan Mok', 'role': 'CONTACT', 'email': 'mok.chui.kwan@skh.com.sg', 'phone': '+65 69302747'}], 'overallOfficials': [{'name': 'Koy Min Chue', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sengkang General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sengkang General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Clinical Assistant Professor, Department of General Surgery', 'investigatorFullName': 'Chue Koy Min', 'investigatorAffiliation': 'Sengkang General Hospital'}}}}