Clinical trial NCT06369194: POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Official title: National Audit of Complications Following Lower Elective Gastrointestinal Surgery Within an Enhanced Recovery After Surgery Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Surgery
Critical Pathways
Enhanced Recovery After Surgery
Retrospective Studies
Chemotherapy, Adjuvant
Lead sponsor: Grupo Español de Rehabilitación Multimodal
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 847
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Disease-free survival
timeFrame: 5 years
measure: Time to disease recurrence
timeFrame: 5 years
measure: Time to return to intended oncologic treatment (RIOT)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios de Alcoy
state: Alicante
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Igualada
country: Spain
facility: Hospital de Igualada
state: Barcelona
city: Sant Joan d'Espi
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: Fundación Hospital del Espíritu Santo
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa
state: Barcelona
city: Vic
country: Spain
facility: Hospital Universitario de Vic
state: Barcelona
city: Castellon de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
state: Castellón
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Mostoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Lorca
country: Spain
facility: Hospital Universitario Rafael Méndez
state: Murcia
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Talavera de la Reina
country: Spain
facility: Hospital Nuestra Señora del Prado
state: Toledo
city: Alava
country: Spain
facility: Hospital Universitario Araba
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clínic Universitat de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebrón
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Galdakao
country: Spain
facility: Hospital de Galdakao-Usansolo
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Salamanca
country: Spain
facility: Complejo Hospitalario de Salamanca
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Consorcio Hospital General Unidersitario de Valencia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Server
Study officials:
References: