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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06369194
• Other study ID #: POWER5
• Status: Active, not recruiting
• Start date: November 14, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Grupo Español de Rehabilitación Multimodal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 847
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Colorectal Surgery
Postoperative Audit

Locations

Country	Name	City	State
Spain	Hospital Universitario Araba	Alava
Spain	Hospital Virgen de los Lirios de Alcoy	Alcoy	Alicante
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 Castellón	Castellon de la Plana	Castellón
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital de Galdakao-Usansolo	Galdakao
Spain	Hospital de Igualada	Igualada	Barcelona
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas
Spain	Hospital Universitario Insular de Gran Canaria	Las Palmas de Gran Canaria
Spain	Hospital Universitario Rafael Méndez	Lorca	Murcia
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	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital Universitario de Móstoles	Mostoles	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Complejo Hospitalario de Salamanca	Salamanca
Spain	Hospital Universitario Donostia	San Sebastián
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 Universitario Virgen Macarena	Sevilla
Spain	Hospital Nuestra Señora del Prado	Talavera de la Reina	Toledo
Spain	Hospital Universitari Mútua Terrassa	Terrassa	Barcelona
Spain	Consorcio Hospital General Unidersitario de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Hospital Universitario de Vic	Vic	Barcelona
Spain	Hospital Universitario Miguel Server	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Rehabilitación Multimodal

Country where clinical trial is conducted

Spain, 

Outcome

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