Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04909567
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2021-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 518}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious complications', 'timeFrame': '30 days', 'description': 'Can preoperative optimization change the proportion of serious complications after surgery (defined according to Clavien 3b-5) in intervention vs. control arm.\n\n) in intervention vs. control arm'}], 'secondaryOutcomes': [{'measure': 'Reoperations', 'timeFrame': '30 days', 'description': 'Change of proportion of reoperations in intervention vs. control arm'}, {'measure': 'Length of stay (LOS)', 'timeFrame': '30 days', 'description': 'Change of LOS (days) in intervention vs. control arm'}, {'measure': 'Working capacity', 'timeFrame': '2-12 weeks', 'description': 'Change of walking distance (meter) in intervention vs. control arm (6 minute walk test)'}, {'measure': 'Weight loss', 'timeFrame': '2-12 weeks', 'description': 'Change of weight loss (kg) in intervention vs. control arm'}, {'measure': 'Psychosocial status', 'timeFrame': '2-12 weeks', 'description': 'Change of points in Hospital and Anxiety scale (HAD) in intervention vs. control arm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS', 'RCT', 'Optimisation'], 'conditions': ['Complication,Postoperative', 'ERAS']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer is one of the most common cancers globally. A majority are operated on for the purpose of cure. Complications after surgery are common, involve long length of stay and increase the risk of later recurrence of cancer. Optimization of physical and mental function before surgery can reduce the risk of complications and provide a faster recovery. However, a standardized form for how optimization should be performed does not exist.\n\nAt Danderyd Hospital, Stockholm, Sweden, we are starting up an optimization center where patients are offered optimizing measures while waiting for surgery. This form of structured treatment has not been studied before and we therefore want to investigate outcomes in a randomized study.\n\nAll patients with colorectal cancer who are being examined for surgery are offered participation in the study. Randomization of 518 patients in to either an intervention group where the patients; are optimized for concomitant diseases, treated for malnutrition and overconsumption of alcohol and tobacco, undergoes an exercise program and receives psychosocial support before surgery, or a control group where patients are prepared for surgery according to current routines. Primary outcome is the difference in severe complications between the groups. Secondary outcome is difference in length of stay as well as fitness and mental well-being before and 30 days after the operation.If optimization before surgery reduces complications and shortens length of stay, the model can also be used by other operating specialties. This may result in a great improvement for the healthcare in general.', 'detailedDescription': 'A randomized controlled, unblinded study with block stratification for surgical procedures.\n\nIntervention arm:\n\nAll patients in the intervention group will be treated in an "optimization center" which constitutes its own physical location at the hospital and functions as a day care unit staffed with doctors, contact nurses, physiotherapists, ERAS nurses and dietitians. An expert team of cardiologists, physiologists, renal physicians and endocrinologists are attached to the unit.\n\nDay 1. (2-12 weeks before the operation). Multipel testing: Clinical status, ASA score, NSQIP score. Alcohol and Smoke score tests. Nutritional score. 6 minute walk test. Psychiatric score tests. If mortality risk \\>5% according to NSQIP, low performance on walk test, chair stand test. ASA 3-4, HbA1c \\>50 for non diabetics, \\>60 for diabetics or (GFR \\<45) = special attention from the expert team.\n\nDay 2 until one week before surgery:\n\nHome exercise 5 days / week. Organised (physiotherapist) exercise 2 days / week. Dietprogram with close follow-up. Psychosocial support. Smoking and alcohol cessation program\n\nThe week before surgery: The same tests as day 1. 30 days posted: The same tests as day 1.\n\nControlarm: The same tests as for the intervention group, day 1, the week before surgery and 30 days post. No interventions during the period.\n\nThe international ERAS database will be used to record data in the study. Consecutive registration of over 300 perioperative variables on each individual patient.\n\nExamples of these variables are basic patient characteristics, preoperative variables such as information before surgery, laxation, nutrition, fluid intake, anemia and glucose optimization. Intraoperative variables such as body temperature, fluid supply, anesthesia method, bleeding, operation time and gastric tube. Postoperative variables such as catheter removal, nutrition, mobilization, nausea, paralytic ileus, specified complications, reoperations and length of stay after surgery. Compliance with the ERAS protocol will be registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients, 18 years or older, with strong suspicion of colorectal cancer\n\nExclusion Criteria:\n\n* Patients with dementia with severe cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04909567', 'acronym': 'OPT', 'briefTitle': "Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery", 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': "Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery -a Randomized Clinical Trial", 'orgStudyIdInfo': {'id': 'RCT: OPTIMIZATION: 2021:9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Optimisation:\n\nDiet, organised exercise, psychosocial support', 'interventionNames': ['Behavioral: Optimisation']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Current standard preparation before surgery'}], 'interventions': [{'name': 'Optimisation', 'type': 'BEHAVIORAL', 'description': 'Defined optimisation', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ulf Gustafsson', 'role': 'CONTACT', 'email': 'ulf.o.gustafsson@regionstockholm.se', 'phone': '46706073828'}], 'facility': 'Ulf Oskar Gustafsson', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Klas Pekkari, MD, PhD,', 'role': 'CONTACT', 'email': 'klas.pekkari@sll.se', 'phone': '46707799817'}, {'name': 'Helene Vibom, nurse', 'role': 'CONTACT', 'email': 'helene.vibom@sll.se', 'phone': 'Danderyd'}], 'overallOfficials': [{'name': 'Ulf Gustafsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Josefin Karlsson, Nurse', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data Availability Statement\n\nDue to Swedish legal restrictions and the current ethical approval for the study, data is not publicly available to share, but the research group can provide descriptive data in table form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Ulf Oskar Gustafsson, MD, PhD', 'investigatorAffiliation': 'Karolinska Institutet'}}}}