POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery (POWER 4 + 3)
POWER 4 + 3
1 other identifier
observational
350
1 country
22
Brief Summary
The main objective of this study is to analyze the impact on three years survival of an enhanced recovery program (PRI) after radical surgert for adenocarcinoma gastric 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 4 (as already foreseen in that study), with the aim of performing a 3-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 Sep 2024
Shorter than P25 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedFirst Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
January 24, 2025
CompletedJanuary 24, 2025
January 1, 2025
5 months
January 17, 2025
January 17, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Overall Survival
Patients alive from surgery to the last control
3 years
Disease-free surviva
Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up
3 years
Time to disease recurrence
Detected from the day of the intervention until the end of follow-up
3 years
Time to return to intended oncologic treatment (RIOT)
Date between discharged and adjuvant treatment
3 years
Interventions
Patients under gastric surgery in an ERAS protocol
Eligibility Criteria
All adult patients (aged ≥18 years) undergoing gastric 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 gastric cancer surgery in POWER4
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 (22)
Hospital Universitario Mancha Centro
Alcázar de San Juan, Spain
Hospital Universitario Cruces
Barakaldo, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Comarcal de Inca
Inca, Spain
Hospital Universitario Lucus Augusti Lugo
Lugo, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario de Móstoles
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital de Mérida
Mérida, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Complejo Asistencial universitario de Salamanca
Salamanca, Spain
Hospital Sant Joan Despi Moises Broggi
Sant Joan Despí, Spain
HU Marqués de Valdecilla
Santander, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Nº Sº Virgen del Prado
Talavera de la Reina, Spain
Hospital Universitario Araba
Vitoria-Gasteiz (Álava), Spain
Related Publications (1)
Ripolles-Melchor J, Abad-Motos A, Leon-Bretscher A, Espinosa AV, Amoza-Pais S, Herrero-Bogajo ML, Abad-Gurumeta A, de-la-Plaza-Llamas R, Galan-Menendez P, Zorrilla-Vaca A, Gonzalez-Lopez R, Navarro-Perez R, Jimenez-Vinas C, Parreno-Manchado FC, Ruiz Escobar A, Concepcion-Martin V, Paseiro-Crespo G, Acosta-Merida MA, Puech-de-Oriol M, Mayo-Ossorio MA, Garcia-Nebreda M, Chaveli-Diaz C, Fernandez-Valdes-Bango P, Torres-Alfonso JR, Barragan-Serrano C, Aldecoa C; POWER4 Investigators Group. Disease-free survival after gastrectomy is not influenced by ERAS adherence. Anaesth Crit Care Pain Med. 2025 Oct 30;45(2):101661. doi: 10.1016/j.accpm.2025.101661. Online ahead of print.
PMID: 41175931DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
January 24, 2025
Study Start
September 1, 2024
Primary Completion
January 15, 2025
Study Completion
January 15, 2025
Last Updated
January 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share