Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER)
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|ClinicalTrials.gov Identifier: NCT03012802|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : February 14, 2018
Short title POWER Audit
Methods 60 days national (Spain) audit of postoperative complications following elective gastrointestinal surgery within an enhanced recovery after surgery (ERAS) protocol.
Research sites Hospitals undertaking elective lower gastrointestinal surgery. Objective To provide detailed data describing post-operative complications and associated mortality; and length of stay.
To provide detailed data describing adherence to ERAS protocol and its association to morbidity.
Number of patients Not specified. All eligible patients undergoing surgery during the study month. Inclusion Criteria All adult patients (aged ≥18 years) undergoing lower gastrointestinal elective surgery within an ERAS protocol during the 60 day study period.
Statistical analysis 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.
Proposed Start Date A 60 day period between 2017
Proposed End Date
Data collection will end by September 2017
Study Duration Six months
|Condition or disease||Intervention/treatment|
|Perioperative Care Postoperative Complications Colorectal Surgery Critical Pathways||Procedure: Colorectal Surgery|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||2050 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Lower Gastrointestinal Surgery|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||February 25, 2018|
|Estimated Study Completion Date :||February 25, 2018|
Procedure: Colorectal Surgery
- The incidence of 60-day predefined (according EPCO guidelines) postoperative complications following elective lower gastrointestinal surgery within any compliance of an ERAS protocol. [ Time Frame: 30 days ]To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.
- 30-day in-hospital mortality associated with these complications [ Time Frame: 30 days ]
- Relationship between ERAS adherence and post- operative complications [ Time Frame: 30 days ]To confirm the relationship between ERAS items (according ERAS guidelines) and the predefined postoperative complications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012802
Show 80 Study Locations
|Study Chair:||Javier Ripollés Melchor, MD||Grupo Español de Rehabilitación Multimodal|
|Principal Investigator:||José María Calvo Vecino, Prof||Grupo Español de Rehabilitación Multimodal|
|Principal Investigator:||Alfredo Abad-Gurumeta, PhD||Grupo Español de Rehabilitación Multimodal|
|Principal Investigator:||José Manuel Ramírez, Prof||Grupo Español de Rehabilitación Multimodal|