POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol

NCT ID: NCT06369194

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 847 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2024-04-15

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).

Detailed Description

Study Data Five-year data will be collected from all eligible patients who have undergone elective colorectal surgery within the POWER1 protocol.

Only 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.

Data 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.

Variables Overall mortality: The number and percentage of deaths occurred since the intervention until the end of the follow-up period.

Overall 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.

Disease recurrence: detected by CT or FCC, from the day of the intervention until the end of the follow-up.

Date until start of adjuvant treatment: date between date of discharge and start of adjuvant treatment

Satistica analyse All regional and institutional level data will be anonymised prior to publication.

Continuous variables will be described as mean and standard deviation, if normally distributed, or median and inter-quartile range, if not normally distributed.

Comparisons of continuous variables will be performed using one-way ANOVA or Mann-Whitney test as appropriate.

Categorical variables will be described as proportions and will be compared using chi-square or Fisher's exact test.

Single-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.

Factors 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.

Results 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.

Survival 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.

Monitoring 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.

Limitations 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.

Conditions

Colorectal Surgery; Critical Pathways; Enhanced Recovery After Surgery; Retrospective Studies; Chemotherapy, Adjuvant

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Colorectal Surgery

Postoperative Audit

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All patients over 18 years of age who underwent elective colorectal cancer surgery in POWER1

Exclusion Criteria

• Non oncological surgery, refusal of the centers to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Español de Rehabilitación Multimodal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Spain

Other Identifiers

POWER5

Identifier Type: -

Identifier Source: org_study_id