Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-25 @ 8:52 AM
Study NCT ID:
NCT05610995
Status:
UNKNOWN
Last Update Posted:
2023-07-27
First Post:
2022-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, multicenter, randomized, two-arm, parallel, open-label, interventional controlled trial with masked outcome assessment (PROBE design)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluating the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis', 'timeFrame': 'at Day 30', 'description': 'Overall length of stay of the patient (index stay, and possible re-hospitalizations)'}], 'secondaryOutcomes': [{'measure': 'Assess transit recovery', 'timeFrame': 'at Day 1', 'description': 'Time of resumption of transit formalized by the resumption of gas, the time being calculated between the closure of the skin and the first gas in hours'}, {'measure': 'Assess pain', 'timeFrame': 'at Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30', 'description': 'Pain, by visual analog scale (0-10)'}, {'measure': 'Assess opioid use', 'timeFrame': 'at Day 5', 'description': '5-day opioid consumption rate'}, {'measure': 'Evaluate the complication rate', 'timeFrame': 'at Day 30 according to the postoperative management performed', 'description': 'Presence of a complication according to the Clavien Dindo classification'}, {'measure': 'Evaluate the rate of re-hospitalization performed', 'timeFrame': 'To the post-surgical hospital discharge at Day 30', 'description': 'Presence of a rehospitalization between the post-surgical hospital discharge and Day 30'}, {'measure': 'Assess the rate of unscheduled visits', 'timeFrame': 'at Day 30', 'description': 'Presence of an unscheduled consultation at Day 30 post-surgery'}, {'measure': "Assess the patient's quality of life and overall satisfaction", 'timeFrame': 'at Day 30', 'description': 'EuroQol 5D 3L standardized scale score (overall satisfaction) at pre-inclusion, Day 1, Day 5 and Day 30 post-surgery visit'}, {'measure': 'Evaluate the cost of care', 'timeFrame': 'To Day 1 at the end of study', 'description': 'Cost analysis (hospitalizations, consultations, re-interventions, time off work, transportation and SENSIUM system costs)'}, {'measure': 'Evaluate the evolution of vital parameters', 'timeFrame': 'To Day 1 at the end of study', 'description': 'Trend analysis of vital parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Exit After Colorectal Surgery']}, 'descriptionModule': {'briefSummary': 'The principal aim of this study is to evaluate the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis.\n\nThe device SENSIUM is a tool to monitor vital signs (respiratory rate, heart rate and temperature) by applying a connected skin patch in order to detect complications early.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. ASA score 1-3\n3. Colonic or rectal resection with anastomosis\n4. Minimally invasive surgery\n5. Patient living close to the hospital (\\<1 hour drive)\n6. Patient accompanied for 48 hours\n7. Body Mass Index \\< 40\n8. Patient information and signature of consent\n9. Patient affiliated to a social insurance plan\n10. A pregnancy test must be performed before inclusion in women of childbearing age.\n\nNon-inclusion Criteria:\n\n1. Socially isolated patient and/or no 3G cell signal\n2. Severe comorbidities defined as any of these characteristics:\n\n 1. Severe malnutrition (albumin \\<30g/l)\n 2. Severe anemia \\< 80 g/dl\n 3. Insulin-dependent diabetes type 1\n\n e. Patient under anticoagulation f. Severe renal insufficiency\n3. History of psychiatric illness with medication requirements\n4. Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection)\n5. Patient not wishing to enter the study\n6. Patient in a period of exclusion from another study or ongoing participation in an interventional study\n\nExclusion Criteria:\n\n1. Stoma preparation\n2. Per operative conversion to laparotomy\n3. CHUNG score \\> 8'}, 'identificationModule': {'nctId': 'NCT05610995', 'acronym': 'Colo-SENSIUM', 'briefTitle': 'Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device', 'orgStudyIdInfo': {'id': '38RC21.0379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SENSIUM Group', 'description': 'Patients in the experimental group will be discharged with the device after an assessment on Day 1.', 'interventionNames': ['Device: SENSIUM Patch']}, {'type': 'NO_INTERVENTION', 'label': 'ERAS standard Group', 'description': 'Patients in the control group will receive the usual ERAS (conventional hospitalization for clinicobiological monitoring).'}], 'interventions': [{'name': 'SENSIUM Patch', 'type': 'DEVICE', 'description': 'The SENSIUM device is a tool to monitor vital signs by applying a connected skin patch whose objective is to detect complications early. The health data is transmitted to the practitioner and in case of disturbance of the parameters, an alert is sent. The patient can be called for consultation or hospitalization if necessary. This device has been tested under real clinical conditions in surgical units. The continuous monitoring of vital signs resulted in earlier detection of sepsis, earlier administration of antibiotics, shorter average length of stay and lower 30-day readmission rates.', 'armGroupLabels': ['SENSIUM Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles SABBAGH, MD', 'role': 'CONTACT'}], 'facility': 'Chu Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélien VENARA, MD', 'role': 'CONTACT'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin DENOST, MD', 'role': 'CONTACT'}], 'facility': 'Clinique TIVOLI', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bogdan BADIC, MD', 'role': 'CONTACT'}], 'facility': 'Chru Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand TRILLING, MD', 'role': 'CONTACT'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène MEILLAT, MD', 'role': 'CONTACT'}], 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie DUCHALAIS, MD', 'role': 'CONTACT'}], 'facility': 'Chu Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Bertrand TRILLING, MD, PhD', 'role': 'CONTACT', 'email': 'BTrilling@chu-grenoble.fr', 'phone': '+33 4 76 76 88 84'}, {'name': 'Fatah TIDADINI', 'role': 'CONTACT', 'email': 'FTidadini@chu-grenoble.fr', 'phone': '+33 4 76 76 70 79'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}