Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369194
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-12
Brief Title:
POWER AUDIT Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Sponsor:
Grupo Español de Rehabilitación Multimodal
Organization:
Grupo Español de Rehabilitación Multimodal
Study Overview
Official Title:
National Audit of Complications Following Lower Elective Gastrointestinal Surgery Within an Enhanced Recovery After Surgery Protocol
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ERASno 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 005 two tails
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 005 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 eg 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 Fishers 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 p005 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 005
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
Only routine clinical data will be included and when not available the field will be left blank eg 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 Fishers 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 p005 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 005
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None