Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 5:40 AM
Study NCT ID:
NCT01148394
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2010-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery After Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-21', 'studyFirstSubmitDate': '2010-06-21', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative stay', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal surgery', 'multimodal rehabilitation', 'fast track', 'early feeding'], 'conditions': ['Fast Track', 'Enhanced Recovery']}, 'referencesModule': {'references': [{'pmid': '21345423', 'type': 'DERIVED', 'citation': 'Garcia-Botello S, Canovas de Lucas R, Tornero C, Escamilla B, Espi-Macias A, Esclapez-Valero P, Flor-Lorente B, Garcia-Granero E. [Implementation of a perioperative multimodal rehabilitation protocol in elective colorectal surgery. A prospective randomised controlled study]. Cir Esp. 2011 Mar;89(3):159-66. doi: 10.1016/j.ciresp.2010.12.004. Epub 2011 Feb 22. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Multimodal rehabilitation (MMR), combines various elements in the management of the surgical patient which lead to a decrease in surgical stress and a more comfortable and faster postoperative recovery.\n\nObjective: To assess the introduction of MMR in a specialized Colorectal Unit and compare the results with the traditional model assessing its´ efficacy as to recovery, and reduction of hospital stay and costs.', 'detailedDescription': 'Materials y Methods: A prospective randomized trial was conducted which analyzed 119 patients who underwent elective colorectal surgery between 2009 and 2010. 58 patients were assigned to the traditional group and 61 patients to the MMR group. MMR included preoperative education, early feeding and mobilisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent elective colorectal surgery between 2009 and 2010.\n* Signed informed consent\n* Live in Valencia metropolitan area\n\nExclusion Criteria:\n\n* Emergency surgery\n* No colonic resection\n* Unable to continue follow-up\n* Dependent on others for daily activities'}, 'identificationModule': {'nctId': 'NCT01148394', 'briefTitle': 'Enhanced Recovery After Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Impact of the Introduction of a Multimodal Rehabilitation Programme for Colorectal Patients. A Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': 'FT-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional', 'description': 'Involves traditional management of patients with preoperative mechanical bowel preparation, no preoperative education, nasogastric tube, delayed feeding and mobilisation, use of drains', 'interventionNames': ['Other: Multimodal rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multimodal rehabilitation', 'description': 'Involves preoperative patient education, no preoperative mechanical bowel preparation, no nasogastric tube, early oral feeding and mobilisation, physiotherapy', 'interventionNames': ['Other: Multimodal rehabilitation']}], 'interventions': [{'name': 'Multimodal rehabilitation', 'type': 'OTHER', 'armGroupLabels': ['Multimodal rehabilitation', 'Traditional']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephanie A Garcia Botello, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico Universitario Valencia'}, {'name': 'Eduardo Garcia-Granero, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clinico Universitario, Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Stephanie Garcia Botello', 'oldOrganization': 'Hospital Clinico Universitario, Valencia'}}}}