An observational study in Colorectal Surgery, Critical Pathways and Enhanced Recovery After Surgery, sponsored by Grupo Español de Rehabilitación Multimodal. Active, not recruiting at 36 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Grupo Español de Rehabilitación Multimodal · Observational
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 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.
Grupo Español de Rehabilitación Multimodal is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients (aged ≥18 years) undergoing colorectal elective surgery within an ERAS protocol (including patients with 0 compliance) in a participating hospital
Exclusion Criteria:
Postoperative Audit
Overall Survival
Patients alive from surgery to the last control
Time frame: 5 years
Disease-free survival
Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up
Time frame: 5 years
Time to disease recurrence
Detected from the day of the intervention until the end of follow-up
Time frame: 5 years
Time to return to intended oncologic treatment (RIOT)
Date between discharged and adjuvant treatment
Time frame: 5 years
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Grupo Español de Rehabilitación Multimodal