Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-12 @ 4:13 PM
Study NCT ID:
NCT03620851
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2018-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-18', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of hospital stay after colorectal surgery (day)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'The duration of hospitalization is defined as the numberof days the patient stays in the hospital between the day of his surgery and the day of his discharge from the hospital'}], 'secondaryOutcomes': [{'measure': 'postoperative complications after colorectal surgery', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'The incidence of postoperative complications (medical and surgical) occurring during the hospital stay and up-to 30-day after surgery will be recorded from our audit database. The following medical complications will be recorded: cardiac, pulmonary, neurological, and uro-nephrologic complications. For surgical complications, we will record postoperative ileus, parietal complications, anastomotic leakage, intra-abdominal sepsis and hemorrhage, unplanned surgery.'}, {'measure': 'adherence to the enhanced recovery program', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'compliance to the different items of the program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['enhanced recovery program', 'colorectal surgery', 'elderly'], 'conditions': ['Colorectal Surgery']}, 'referencesModule': {'references': [{'pmid': '31377111', 'type': 'DERIVED', 'citation': 'Joris J, Hans G, Coimbra C, Decker E, Kaba A. Elderly patients over 70 years benefit from enhanced recovery programme after colorectal surgery as much as younger patients. J Visc Surg. 2020 Feb;157(1):23-31. doi: 10.1016/j.jviscsurg.2019.07.011. Epub 2019 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of the efficiency of enhanced recovery program after colorectal surgery in elderly patients (≥ 70 yo) and younger patients (\\< 70 yo). Efficiency will be rated as a function of length of hospital stay, postoperative complications (medical and surgical, as well as adherence to protocol.', 'detailedDescription': 'In 1995 Henrik Kehlet described the concept of fast track surgery after colectomy. It consisted of a multimodal and multidisciplinary approach that aimed at controlling the surgical stress response and at mitigating its consequences. Subsequently postoperative recovery is improved and accelerated, which allows a median hospital stay of 2-days after laparoscopic colectomy. The concept of fast track surgery progressively evolved into enhanced recovery programme (ERP). The acceleration of postoperative recovery and the reduction in the duration of hospitalisation are not associated with an increased incidence of surgical complications nor a greater rate of unplanned hospital readmission, but rather result in less medical complications. The economic benefits are obvious.\n\nThe elderly present specific physical, metabolic and socio-environmental characteristics that should be considered in case of surgery. Age has been shown to be an independent prognostic factor for postoperative morbidity after colorectal surgery, but this was reported before the development of ERP. Indeed implementation of ERP significantly reduces the rate of postoperative complications, even in the elderly. Increased risk of postoperative morbidity in elderly as compared to younger patients is nevertheless commonly admitted. Moreover adherence of elderly with the items of ERP is usually considered inferior than that of younger patients. Adaptation of ERP to the specificities of elderly is sometimes advocated. All these explain the reluctance of many practitioners to propose ERP in older patients. However recent meta-analyses suggest that implementation of ERP is feasible and efficient in these patients. The retrospective analysis of our first 100 patients introduced in our audit database revealed even similar length of hospital stay for elderly and younger patients.\n\nThe investigators therefore compared the length of hospital stay in the elderly and the younger patients and tested the hypothesis of non-inferiority for elderly patients as compared to younger patients. This is a retrospective analysis of 270 consecutive patients scheduled for colorectal surgery, all managed with the same ERP protocol, and prospectively introduced in our audit database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for colorectal surgery have been included in an enhanced recovery program (ERP) since the 1st November 2015. Preoperative characteristics, surgical and anesthetic data, as well postoperative parameters and complications have been entered prospectively in the GRACE (Groupe francophone de Réhabilitataion Améliorée après ChirurgiE)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n• All patients scheduled for colorectal surgery since November 2015\n\nExclusion Criteria:\n\n• Emergency surgery'}, 'identificationModule': {'nctId': 'NCT03620851', 'acronym': 'ERPOLD', 'briefTitle': 'Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Effect of Age on the Efficiency of Enhanced Recovery Program After Colorectal Surgery', 'orgStudyIdInfo': {'id': 'ERPELDERLY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'elderly patients (≥70 yo) vs. younger patients (<70 yo)', 'description': 'elderly patients (≥ 70 yo) and younger patients (\\< 70 yo)', 'interventionNames': ['Other: effect of age']}], 'interventions': [{'name': 'effect of age', 'type': 'OTHER', 'description': 'effect of age on the efficiency of enhanced recovery program', 'armGroupLabels': ['elderly patients (≥70 yo) vs. younger patients (<70 yo)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liége', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Jean L Joris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Liege, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Anesthesiology', 'investigatorFullName': 'Jean François Brichant', 'investigatorAffiliation': 'University of Liege'}}}}