National Audit of Complications Following Lower Elective Gastrointestinal Surgery Within an Enhanced Recovery After Surgery Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 847
- Locations
- 36
- Primary Endpoint
- Time to return to intended oncologic treatment (RIOT)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Time to return to intended oncologic treatment (RIOT)
Time Frame: 5 years
Date between discharged and adjuvant treatment
Overall Survival
Time Frame: 5 years
Patients alive from surgery to the last control
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
Time to disease recurrence
Time Frame: 5 years
Detected from the day of the intervention until the end of follow-up
Secondary Outcomes
No secondary outcomes reported