Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)
NCT03814681 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 8000
Last updated 2019-01-25
Summary
Methods
30 days European Multicentre observational cohort study of postoperative complications following elective colorectal surgery within any compliance of an ERAS protocol (including patients with 0 compliance) in a participating hospital during the 30-day cohort period with a planned overnight stay.
Research sites
Hospitals across Europe with an elective colorrectal surgical service
Objective
To provide detailed data describing post-operative complications and associated mortality To provide detailed data describing adherence to ERAS protocol and its association to morbidity and length of stay.
To provide detailed information on the influence of the volume of patients undergoing surgery on each center and postoperative complications censured at 30 days after surgery.
Inclusion criteria All adult patients (aged ≥18 years) undergoing elective colorectal surgery during the 30-day study period.
Statistical analysis Number of patients: All eligible patients undergoing elective colorectal surgery during the study month in European participating hospitals.
Univariate analysis will be used to test factors (patient, surgical, and ERAS related) associated with surgical complications, length of stay (LOS) and in-hospital death. Single and multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. A stepwise approach will be used to enter new terms. A single final analysis is planned at the end of the study.
Summary statistics with post hoc Bonferroni corrections will be used to assess possible dose- response dependence in percentage of patients with postoperative complications and LOS.
Conditions
- Perioperative Care
- Colorectal Surgery
- Postoperative Complications
Interventions
- OTHER
-
Colorectal Surgery
elective Colorectal Surgery
Sponsors & Collaborators
-
GRACE Group
collaborator OTHER -
REDGERM
collaborator UNKNOWN -
Grupo Español de Rehabilitación Multimodal
lead OTHER
Principal Investigators
-
Javier Ripollés-Melchor, MD · Infanta Leonor University Hospital, Madrid, Spain
-
Rupert Pearse, Prof · Queen Mary University London, London, UK
-
José M Ramírez Rodríguez, Prof · Lozano Blesa University Hospital, Zaragoza, Spain
-
Samir Jaber, Prof · Hospitalier Universitaire de Montpellier, France
-
Karim Slim, Prof · Président de GRACE
-
César Aldecoa, Prof · Río Hortega University Hospital, Valladolid, Spain
-
Nader Francis, Prof · Yeovil District Hospital NHS Foundation Trust
-
Ane Abad-Motos, MD · Infanta Leonor University Hospital, Madrid, Spain
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-15
- Primary Completion
- 2019-12-15
- Completion
- 2020-01-15
Countries
- Spain
Study Locations
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