Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT06369194
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 847}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Patients alive from surgery to the last control'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up'}, {'measure': 'Time to disease recurrence', 'timeFrame': '5 years', 'description': 'Detected from the day of the intervention until the end of follow-up'}, {'measure': 'Time to return to intended oncologic treatment (RIOT)', 'timeFrame': '5 years', 'description': 'Date between discharged and adjuvant treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Surgery', 'Critical Pathways', 'Enhanced Recovery After Surgery', 'Retrospective Studies', 'Chemotherapy, Adjuvant']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).\n\nIt is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up.\n\nTo create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \\<0.05 (two tails).', 'detailedDescription': "Study Data Five-year data will be collected from all eligible patients who have undergone elective colorectal surgery within the POWER1 protocol.\n\nOnly routine clinical data will be included and, when not available, the field will be left blank, e.g., patients lost to follow-up. Regional groups may supplement their basic data set with a very limited number of additional variables.\n\nData collection The data will be collected from CRFs collected in POWER1. The list of pseudo-anomized patients delivered at the time will be provided with the new variables to be completed by the centers.\n\nVariables Overall mortality: The number and percentage of deaths occurred since the intervention until the end of the follow-up period.\n\nOverall survival: patients alive from surgery to the last control. Disease-free survival: number of patients alive and without cancer recurrence from the intervention period until the end of follow-up.\n\nDisease recurrence: detected by CT or FCC, from the day of the intervention until the end of the follow-up.\n\nDate until start of adjuvant treatment: date between date of discharge and start of adjuvant treatment\n\nSatistica analyse All regional and institutional level data will be anonymised prior to publication.\n\nContinuous variables will be described as mean and standard deviation, if normally distributed, or median and inter-quartile range, if not normally distributed.\n\nComparisons of continuous variables will be performed using one-way ANOVA or Mann-Whitney test as appropriate.\n\nCategorical variables will be described as proportions and will be compared using chi-square or Fisher's exact test.\n\nSingle-level and hierarchical multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors.\n\nFactors will be entered into the models based on their univariate relation to outcome (p\\<0.05), biological plausibility and low rate of missing data. A stepwise approach will be used to enter new terms.\n\nResults of logistic regression will be reported as adjusted odds ratios (OR) with 95% confidence intervals. The models will be assessed through the use of sensitivity analyses to explore possible interacting factors and examine any effect on the results. A single final analysis is planned at the end of the study.\n\nSurvival analyzes will be performed using the Kaplan-Meier method for survival comparisons the log-rank test will be used. The effects will be considered significant if p \\<0.05.\n\nMonitoring and audit The data collection documents will be audited to ensure that study activities are carried out in accordance with the protocol, good clinical practice and applicable regulatory requirements. In the participating hospitals, local study documents can be selected for local auditing. The quality of the data will be audited.\n\nLimitations of the study Those of a prospective non-randomized study. Difficulty in recruiting patients for potential structural or multidisciplinary team problems. Inappropriate number of patients due loss of follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (aged ≥18 years) undergoing colorectal elective surgery within an ERAS protocol (including patients with 0 compliance) in a participating hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 18 years of age who underwent elective colorectal cancer surgery in POWER1\n\nExclusion Criteria:\n\n* Non oncological surgery, refusal of the centers to participate.'}, 'identificationModule': {'nctId': 'NCT06369194', 'briefTitle': 'POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Grupo Español de Rehabilitación Multimodal'}, 'officialTitle': 'National Audit of Complications Following Lower Elective Gastrointestinal Surgery Within an Enhanced Recovery After Surgery Protocol', 'orgStudyIdInfo': {'id': 'POWER5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colorectal Surgery', 'type': 'PROCEDURE', 'description': 'Postoperative Audit'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alcoy', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Virgen de los Lirios de Alcoy', 'geoPoint': {'lat': 38.70545, 'lon': -0.47432}}, {'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': 'Igualada', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Igualada', 'geoPoint': {'lat': 41.58098, 'lon': 1.6172}}, {'city': "Sant Joan d'Espi", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sant Joan Despí Moisès Broggi'}, {'city': 'Santa Coloma de Gramenet', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Fundación Hospital del Espíritu Santo', 'geoPoint': {'lat': 41.45152, 'lon': 2.2081}}, {'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Mútua Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'city': 'Vic', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario de Vic', 'geoPoint': {'lat': 41.93012, 'lon': 2.25486}}, {'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Hospital General Universitario de Castellón', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'Móstoles', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Móstoles', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'city': 'Lorca', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Rafael Méndez', 'geoPoint': {'lat': 37.67119, 'lon': -1.7017}}, {'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Talavera de la Reina', 'state': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora del Prado', 'geoPoint': {'lat': 39.96348, 'lon': -4.83076}}, {'city': 'Alava', 'country': 'Spain', 'facility': 'Hospital Universitario Araba', 'geoPoint': {'lat': 43.36057, 'lon': -6.19946}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic Universitat de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Vall d´Hebrón', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Hospital General Universitario de Ciudad Real', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'city': 'Galdakao', 'country': 'Spain', 'facility': 'Hospital de Galdakao-Usansolo', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'city': 'Las Palmas', 'country': 'Spain', 'facility': 'Hospital Universitario de Gran Canaria Doctor Negrín', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Hospital Universitario Insular de Gran Canaria', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'San Sebastián', 'country': 'Spain', 'facility': 'Hospital Universitario Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Consorcio Hospital General Unidersitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Server', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Español de Rehabilitación Multimodal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}