Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05738902 |
| Other study ID # |
ERASGYNBS002 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2023 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
| Contact |
Federico Ferrari, MD, PhD |
| Phone |
00390303995341 |
| Email |
federico.ferrari[@]unibs.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of the study is to investigate the association between early non-compliance to ERAS
in postoperative day 2 (POD2) with the rate of postoperative complications.
Description:
The aim of this prospective multicenter observational study is to investigate the association
between the early non-compliance to ERAS in postoperative day 2 (POD2) with the rate of
postoperative complications, in women undergoing open surgery for gynecological cancer.
Every POD is defined from 8.00 AM of the same day until 8.00 AM of the day after. Namely,
POD0 is the day of surgery, while POD1 is the first day after surgery and so on.
According to the ERAS protocol the same day of surgery (POD0) the patients should be
mobilized out of bed and allowed to take liquids by mouth at will. Removal of urinary
catheter and starting of oral feeding is planned on POD1. Intravenous fluid infusion is
stopped as early as possible according to oral feeding recovery at POD1.
POD2 is considered more adequated to measure the early ERAS compliance compared to POD1. In
fact, according to previous published data in colonic surgery, a small delay in recovery
within an ERAS pathway in POD1, can be the reflection of inadvertent intraoperative fluid
overload, inadequate control pain and missing nausea and vomiting prophylasis. Moreover, late
end time of surgery can further impair the full application of ERAS during POD1.
The compliance of the participants will be assessed in POD2 using the following 5 indicators
derived from ERAS items.
1. Poorly controlled pain with NRS>3, measured using a dedicated Patient Reported Outcomes
form administered at 8 PM of POD2, covering the last 12 hours. The need of rescue dose
of antalgic therapy does not affect the status of poorly controlled pain.
2. Failure to remove urinary catheter, namely the manteinance of the catether after 8.00 AM
of POD2.
3. Administration of intravenous infusion as hydration therapy after 8.00 AM of POD2.
4. Failure to have an adequate oral intake (namely refusal of having one or more of the
proposed meals, producing hence a calories deficit).
5. Poor mobilization, defined as less than 4 hours outside the bed during whole POD2.
Any postoperative complications will be recorded up to 30 days and classified according to
Clavien Dindo classification. Complications graded as III or greater were considered as
major.
STATISTICAL PLAN
According to the literature, the complication rate for gynecological surgery in the
oncological field under the ERAS protocol is around 25%. A sample of 600 patients produces a
95% confidence interval ranging from 21.5% to 28.5%, with an estimate precision (semi-width
of the confidence interval) equal to 3.5%.
Based on the five ERAS indicators of compliance as predictors (independent variables), the
sample size is calculated using the generic rule of 10 events for each independent variable
(15 variables), corresponding to 150 events. Considering the aforementioned complication rate
(25%), the sample must be at least 600 patients. Reasoning on a single ERAS item represented
in about 40% of the patients, a number of 600 guarantees to highlight an OR equal to 2.5 in a
logistic model that considers other independent binary variables with a correlation of 0.7
between them.
The collected data will first be synthesized using the tools of descriptive statistics, with
categorical variables synthesized through absolute and relative frequencies, and quantitative
variables through mean ± standard deviation, or median and interquartile range. The
complication rate will be summarized in terms of proportion (percentage) with relative 95%
confidence interval calculated using the Clopper-Pearson estimator. The chi-square test, with
Fisher's exact variant in the case of expected frequencies less than 5, will be used to
evaluate the association between categorical variables and i) adherence to ERAS (in terms of
the number of indicators considered) and ii) the primary outcome (complications). For
normally distributed quantitative variables the ANOVA test will be used; in the absence of
the normality assumption underlying the test, the Kruskal-Wallis non-parametric test will be
employed. Appropriate post-hoc comparisons, taking into account test multiplicity
(multiples), will be conducted to identify ERAS item "pairs" that show statistical
significance with the primary outcome.
The logistic regression model will be used to quantify the association and magnitude between
the five ERAS indicators considered individually and the primary outcome represented by the
presence of postoperative complications. An ordinal variable will also be constructed, with
values from 1 to 5, which summarizes adherence to the five ERAS indicators. The magnitude of
the association between the five ERAS indicators will first be quantified in terms of Odds
Ratio (OR) and related confidence interval in a univariate setting, and then in a
multivariate model that will consider the above adjustment variables. In the construction of
the multivariate model, methods for choosing the predictors will be taken into consideration,
such as the backward (and/or stepwise) technique. The results of the regression model will
also be graphically represented through the "confidence-interval plot", a graphical
representation that summarizes the punctual estimate of the OR and its 95% confidence
interval. All analyzes will be performed considering a type I error α equal to 5%.
