Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-28 @ 8:47 PM
Study NCT ID:
NCT04595604
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2020-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}, {'id': 'D000080482', 'term': 'Enhanced Recovery After Surgery'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators and assessors will be blinded regarding preoperative preparation. Both randomization process and rehabilitation process will be carried out by a trained nurse, physiotherapist and psychotherapist, neither of them will be involved in outcome assessment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation.\n\n2:1 randomization will be performed for interventional and control arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '45 days', 'description': 'Postoperative length of hospital stay in days.'}, {'measure': 'Number of days spent on ICU (Intensive care unit).', 'timeFrame': '45 days', 'description': 'Number of days observed on ICU right after operation.'}, {'measure': 'Morbidity (early) classified after Clavien-Dindo.', 'timeFrame': '7 days (until 8th postoperative day) postoperative', 'description': '7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.'}, {'measure': 'Morbidity (long term) classified after Clavien-Dindo.', 'timeFrame': '30 days (until 31st postoperative day)', 'description': '30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.'}, {'measure': '30-day mortality', 'timeFrame': '30 days (until 31st postoperative day)', 'description': '30-day mortality of each patient will be recorded.'}, {'measure': '90-day mortality', 'timeFrame': '90 days (until 91st postoperative day)', 'description': '90-day mortality of each patient will be recorded.'}, {'measure': 'Change in preoperative functional status - 6MWD by operation', 'timeFrame': 'Measured points: 4 weeks before surgery, on day of hospital admission', 'description': '6MWD (6-minute walking distance test)'}, {'measure': 'Change in postoperative functional status - 6MWD by the end of rehabilitation', 'timeFrame': 'Measured points: 4 weeks before surgery, 8 weeks after operation', 'description': '6MWD (6-minute walking distance test)'}, {'measure': 'Change in preoperative functional status - FVC by operation', 'timeFrame': 'Measured points: 4 weeks before surgery, on day of hospital admission', 'description': 'Measured points: 4 weeks before surgery, on day of hospital admission'}, {'measure': 'Change in preoperative functional status - FVC by the end of rehabilitation', 'timeFrame': 'Measured points: 4 weeks before surgery, 8 weeks after operation', 'description': 'Measured points: 4 weeks before surgery, 8 weeks after operation'}], 'secondaryOutcomes': [{'measure': 'Change of alpha- and beta-diversity of fecal microbata', 'timeFrame': 'Measured points: 4 weeks before surgery, on day of hospital admission and 8 weeks after surgery', 'description': 'Fecal microbara diversity will be measured at diagnosis, at the time of operation and 8 weeks after operation. We will assess diversity changes related to the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS', 'prehabilitation', 'fecal microbata'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '37162250', 'type': 'DERIVED', 'citation': 'Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.'}, {'pmid': '35588252', 'type': 'DERIVED', 'citation': 'Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.\n\nERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.\n\nTrimodal Prehabilitation Program is a recently introduced preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.\n\nThis study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.\n\nAdditionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.', 'detailedDescription': 'Aim:\n\nColorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.\n\nIn the prospective, randomized (2:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.\n\nStudy protocol in details:\n\nFirst visit: Outpatient Department of Surgery\n\nOn both arms:\n\n* History taking (including family history and oncologic history);\n* Physical examination\n\nOperation indication, type of procedure and date of procedure agreed; Organizing further investigations, anesthesia; Operative risk assessment ("ACS - surgical risk calculator"); Study patient identifier Nr generated; Nurse-led ERAS/Prehab clinic: randomization\n\nOn both arms:\n\n* Randomization (Prehabilitation Program / ERAS Program). 2:1\n* Nurse led clinic assessment ("study nurse"):\n\n.i. CaseReportForm (CRF) filled in.\n\n.ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI, MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol consumption, anxiety, depression, sleeping disorders).\n\n.v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum score). .vii. Preoperative counseling (operation type, preparation, pain management, discharge plan).\n\n.viii. Preoperative nutritional planning (education, nutrient prescription). .ix. Alcohol intake and smoking cessation - information given. .x. Stoma education started. . xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral. xiii. Fecal sample collected and stored at -86 C.\n\nPhysiotherapy, first visit\n\nBoth on control and interventional arms:\n\n* Respiratory function test recorded.\n* Physical status tested (6MWD) on a treadmill.\n\nJust on Prehabilitation arm:\n\n* Respiratory training education.\n* Respiratory trainer device usage educated.\n* Daily activity (walking) planned.\n\nPhysiotherapy - second/third/fourth visit (weekly)\n\nJust on Prehabilitation arm:\n\nPrevious week activity reviewed as to workbook. Physical assessment: 6MWD, FVC. Next week activity planned. Psychic preparation\n\nJust on Prehabilitation arm:\n\n• Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program.\n\nAdmission to the Surgical Ward a day before surgery\n\nBoth on control and interventional arm:\n\n* Preoperative assessment:\n\n.i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular stage (resting HR and RR), ECG. .iii. Respiratory function tests. .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale (HADS)) assessment. vi. Fecal sample collected and stored at -86 C.\n\n* Preoperative preparation (as to ERAS protocol).\n* Postoperative care (ITU, pain management, mobilization, oral nutrition built up, drains early removal, complications recorded (Clavien-Dindo-classification)).\n* Stoma education.\n\nDietary education. On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND Medical Outcomes Study).\n\nPostoperative follow up:\n\nBoth on control and interventional arms:\n\n• Assessment (8th week post op.):\n\n.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD). .v. Fecal sample collected and stored at -86 C.\n\n\\- Long-term follow-up: 12, 24, 36, 48 and 60 months post operative assessment: Behavioral changes (alcohol abstinence, smoking cessation) Daily physical activity routine assessment. SF36 quality of life assessment Oncological outcome: local recurrence rate, distant recurrence rate, disease free survival, overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with histologically proven primary colorectal adenocarcinoma\n* any stage of colorectal cancer\n* elective operation\n* curative intention\n* informed consent signed by patient\n\nExclusion Criteria:\n\n* emergency operation\n* palliative operation\n* non-colorectal, second malignancy\n* pregnancy\n* patient not giving consent'}, 'identificationModule': {'nctId': 'NCT04595604', 'acronym': 'Prehab_2', 'briefTitle': 'Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'St. Borbala Hospital'}, 'officialTitle': 'Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.', 'orgStudyIdInfo': {'id': 'ERASvsPrehab_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trimodal prehabilitation + ERAS', 'description': 'Patients receiving a formal preoperative preparation on:\n\nPhysical status (walking, respiratory training) Nutrition (nutritional supplements) Mental status (weekly groups led by clinical psychologist on anxiety and depression management).\n\nEach patient will be treated in an ERAS program preoperatively.', 'interventionNames': ['Procedure: Trimodal rehabilitation + ERAS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ERAS + nutritional prehabilitation', 'description': 'Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements.', 'interventionNames': ['Procedure: ERAS + nutritional prehabilitation']}], 'interventions': [{'name': 'Trimodal rehabilitation + ERAS', 'type': 'PROCEDURE', 'otherNames': ['Prehabilitation'], 'description': 'Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.', 'armGroupLabels': ['Trimodal prehabilitation + ERAS']}, {'name': 'ERAS + nutritional prehabilitation', 'type': 'PROCEDURE', 'otherNames': ['Enhanced Recovery After Surgery'], 'description': 'Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.', 'armGroupLabels': ['ERAS + nutritional prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2800', 'city': 'Tatabánya', 'country': 'Hungary', 'facility': 'Department of Surgery, St. Borbala Hospital', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}, {'zip': '2800', 'city': 'Tatabánya', 'country': 'Hungary', 'facility': 'St. Borbala Hospital', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '10 years', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Borbala Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Biological Research Centre, Szeged', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}