Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT05598294
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2022-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'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': ['CARE_PROVIDER']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to start flatus', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Rate of Complications', 'timeFrame': '1 year'}, {'measure': 'Length of stay', 'timeFrame': '1 year'}, {'measure': 'Rate of Mortality', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ambulation Difficulty', 'Physical Examination']}, 'referencesModule': {'references': [{'pmid': '30707226', 'type': 'BACKGROUND', 'citation': 'Daskivich TJ, Houman J, Lopez M, Luu M, Fleshner P, Zaghiyan K, Cunneen S, Burch M, Walsh C, Paiement G, Kremen T, Soukiasian H, Spitzer A, Jackson T, Kim HL, Li A, Spiegel B. Association of Wearable Activity Monitors With Assessment of Daily Ambulation and Length of Stay Among Patients Undergoing Major Surgery. JAMA Netw Open. 2019 Feb 1;2(2):e187673. doi: 10.1001/jamanetworkopen.2018.7673.'}, {'pmid': '3558716', 'type': 'BACKGROUND', 'citation': 'Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.'}, {'pmid': '24422666', 'type': 'BACKGROUND', 'citation': 'Heron N, Tully MA, McKinley MC, Cupples ME. Physical activity assessment in practice: a mixed methods study of GPPAQ use in primary care. BMC Fam Pract. 2014 Jan 15;15:11. doi: 10.1186/1471-2296-15-11.'}, {'pmid': '32459426', 'type': 'RESULT', 'citation': 'Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.'}]}, 'descriptionModule': {'briefSummary': 'The clinical progress of the patients whose mobilization the investigators follow up with wearable technology products will be observed in the early postoperative period until discharge. In this way, the investigators primarily aim to examine whether the bowel movements of our more mobilized patients return earlier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent laparoscopic abdominal surgery\n* Colorectal cancer patients\n* Curative surgeries\n* Stage 0,1,2,3 patients\n\nExclusion Criteria:\n\n* Patients who cannot walk\n* Patients converted to open procedure\n* Patients with ostomy\n* Patients for whom laparoscopy is contraindicated\n* Palliative surgeries\n* Patients with distant organ metastases'}, 'identificationModule': {'nctId': 'NCT05598294', 'briefTitle': 'Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery', 'orgStudyIdInfo': {'id': 'AnkaraUSurgOnc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Standard treatment and mobilization recommendations will be given to this group.'}, {'type': 'EXPERIMENTAL', 'label': 'Mobilization Group', 'description': 'Mobilization of patients will be encouraged.', 'interventionNames': ['Procedure: Mobilization recommendations']}], 'interventions': [{'name': 'Mobilization recommendations', 'type': 'PROCEDURE', 'description': 'Standard mobilization recommendations will be given to all patients, and feedback will be given to the intervention group to increase the number of steps 4 times a day according to the daily targeted number of steps.', 'armGroupLabels': ['Mobilization Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06620', 'city': 'Ankara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali Ekrem Unal, Professor', 'role': 'CONTACT', 'email': 'aliekremunal@yahoo.com', 'phone': '+905555137136'}], 'facility': 'Ankara University Faculty of Medicine, Surgical Oncology Department', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06620', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali Ekrem Unal, MD', 'role': 'CONTACT'}], 'facility': 'Ankara University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Kamil Erozkan, Fellow', 'role': 'CONTACT', 'email': 'kamilerozkan@gmail.com', 'phone': '+905366154532'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If requested, individual participant data (IPD) will be shared via e-mail after the reason has been evaluated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Fellow', 'investigatorFullName': 'Kamil Erozkan', 'investigatorAffiliation': 'Ankara University'}}}}