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

April 18, 2024 updated by: Grupo Español de Rehabilitación Multimodal

National Audit of Complications Following Lower Elective Gastrointestinal Surgery Within an Enhanced Recovery After Surgery Protocol

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Procedure: Colorectal Surgery

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.

Study Type

Observational

Enrollment (Actual)

847

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Alava, Spain
    - Hospital Universitario Araba
  - Alicante, Spain
    - Hospital General Universitario de Alicante
  - Barcelona, Spain
    - Hospital Del Mar
  - Barcelona, Spain
    - Hospital Universitario Vall d´Hebron
  - Barcelona, Spain
    - Hospital Clínic Universitat de Barcelona
  - Barcelona, Spain
    - Hospital Universitario Santa Creu i Sant Pau
  - Ciudad Real, Spain
    - Hospital General Universitario de Ciudad Real
  - Galdakao, Spain
    - Hospital de Galdakao-Usansolo
  - Las Palmas, Spain
    - Hospital Universitario de Gran Canaria Doctor Negrin
  - Las Palmas de Gran Canaria, Spain
    - Hospital Universitario Insular de Gran Canaria
  - Madrid, Spain
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain
    - Hospital de La Princesa
  - Madrid, Spain
    - Hospital Universitario San Carlos
  - Madrid, Spain
    - Hospital Universitario Infanta Leonor
  - Salamanca, Spain
    - Complejo Hospitalario de Salamanca
  - San Sebastián, Spain
    - Hospital Universitario Donostia
  - Sevilla, Spain
    - Hospital Universitario Virgen Macarena
  - Valencia, Spain
    - Hospital Clínico Universitario de Valencia
  - Valencia, Spain
    - Consorcio Hospital General Unidersitario de Valencia
  - Valladolid, Spain
    - Hospital Clínico de Valladolid
  - Zaragoza, Spain
    - Hospital Universitario Miguel Server
- Alicante
  - Alcoy, Alicante, Spain
    - Hospital Virgen de los Lirios de Alcoy
  - Elche, Alicante, Spain
    - Hospital General Universitario de Elche
- Asturias
  - Oviedo, Asturias, Spain
    - Hospital Universitario Central de Asturias
- Barcelona
  - Igualada, Barcelona, Spain
    - Hospital de Igualada
  - Sant Joan d'Espi, Barcelona, Spain
    - Hospital de Sant Joan Despi Moises Broggi
  - Santa Coloma De Gramenet, Barcelona, Spain
    - Fundación Hospital del Espíritu Santo
  - Terrassa, Barcelona, Spain
    - Hospital Universitari Mutua Terrassa
  - Vic, Barcelona, Spain
    - Hospital Universitario de Vic
- Castellón
  - Castellon de la Plana, Castellón, Spain
    - Hospital General Universitario de Castellón
- Madrid
  - Majadahonda, Madrid, Spain
    - Hospital Universitario Puerta De Hierro
  - Mostoles, Madrid, Spain
    - Hospital Universitario de Móstoles
- Murcia
  - Lorca, Murcia, Spain
    - Hospital Universitario Rafael Méndez
- Málaga
  - Marbella, Málaga, Spain
    - Hospital Costa del Sol
- Toledo
  - Talavera de la Reina, Toledo, Spain
    - Hospital Nuestra Señora del Prado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

All adult patients (aged ≥18 years) undergoing colorectal elective surgery within an ERAS protocol (including patients with 0 compliance) in a participating hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: 5 years	Patients alive from surgery to the last control	5 years
Disease-free survival Time Frame: 5 years	Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up	5 years
Time to disease recurrence Time Frame: 5 years	Detected from the day of the intervention until the end of follow-up	5 years
Time to return to intended oncologic treatment (RIOT) Time Frame: 5 years	Date between discharged and adjuvant treatment	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Rehabilitación Multimodal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria