POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
National Audit of Complications Following Lower Elective Gastrointestinal Surgery Within an Enhanced Recovery After Surgery Protocol
1 other identifier
observational
847
1 country
36
Brief Summary
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). It 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. To 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Shorter than P25 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2023
CompletedFirst Submitted
Initial submission to the registry
April 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 16, 2024
CompletedApril 19, 2024
April 1, 2024
5 months
April 12, 2024
April 18, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Overall Survival
Patients alive from surgery to the last control
5 years
Disease-free survival
Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up
5 years
Time to disease recurrence
Detected from the day of the intervention until the end of follow-up
5 years
Time to return to intended oncologic treatment (RIOT)
Date between discharged and adjuvant treatment
5 years
Interventions
Postoperative Audit
Eligibility Criteria
All adult patients (aged ≥18 years) undergoing colorectal elective surgery within an ERAS protocol (including patients with 0 compliance) in a participating hospital
You may qualify if:
- All patients over 18 years of age who underwent elective colorectal cancer surgery in POWER1
You may not qualify if:
- Non oncological surgery, refusal of the centers to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Hospital Virgen de los Lirios de Alcoy
Alcoy, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital de Igualada
Igualada, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan d'Espi, Barcelona, Spain
Fundación Hospital del Espíritu Santo
Santa Coloma de Gramenet, Barcelona, Spain
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Vic
Vic, Barcelona, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Universitario Rafael Méndez
Lorca, Murcia, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, Spain
Hospital Universitario Araba
Alava, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Clínic Universitat de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Vall d´Hebrón
Barcelona, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Hospital de Galdakao-Usansolo
Galdakao, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Hospital de La Princesa
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario San Carlos
Madrid, Spain
Complejo Hospitalario de Salamanca
Salamanca, Spain
Hospital Universitario Donostia
San Sebastián, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Consorcio Hospital General Unidersitario de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Clínico de Valladolid
Valladolid, Spain
Hospital Universitario Miguel Server
Zaragoza, Spain
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2024
First Posted
April 16, 2024
Study Start
November 14, 2023
Primary Completion
April 15, 2024
Study Completion
April 15, 2024
Last Updated
April 19, 2024
Record last verified: 2024-04