An observational study in Perioperative Care, Postoperative Complications and Gastric Cancer, sponsored by Grupo Español de Rehabilitación Multimodal. Status unknown at 66 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Grupo Español de Rehabilitación Multimodal · Observational
Methods National audit of a 90-day prospective observational cohort in which postoperative complications will be analyzed at 30 days of follow-up in adult patients undergoing scheduled surgery for gastric resection for cancer with or without an intensified recovery program (ERAS : Enhanced Recovery after Surgery) with any level of protocol compliance (from 0-100%)
Research Locations Spanish Hospitals at the state level where these surgical interventions are performed on a regular basis.
Objectives To determine the incidence of postoperative complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the hospital stay and postoperative complications including 30-day mortality.
Sample Size For an alpha error of 5% (95% confidence) and an accuracy of 3% and estimating a number of patients with complications of 28%, the sample size calculation yields 861 patients, although the final sample size it may be smaller depending on the proportion of complications detected.
Inclusion criteria Patients older than 18 years who are going to undergo surgery for gastric resection surgery due to cancer regardless of their affiliation to an ERAS intensified recovery program and the compliance level of the protocol (0-100%)
Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not normally distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the factors associated with postoperative complications, hospital stay and death in the hospital. Univariate analyzes and hierarchical multivariate logistic regression models will be constructed to identify factors associated independently with these results and to adjust for differences in confounding factors. The factors will be introduced in the models based on their relationship with the univariate result (p \<0.05), the biological plausibility and the low rate of missing data.
The results of this study will allow to identify, on the one hand, the type of patients presenting postoperative complications and, on the other hand, to identify those items of the ERAS protocols that are independently associated with a reduction in postoperative complications and hospital stay, which will allow to focus the perioperative efforts in those items that actually improve the postoperative outcomes.
Aim 1 will establish the number of patients developing predefined postoperative complications within 30 days of surgery in adult patients undergoing scheduled surgery for gastric resection for cancer with any compliance of an ERAS protocol (including patients with 0 compliance). This will allow us to determine the actual impact of these protocols.
Aim 2 will allow us to know the type of predefined complication presented by the patients included in the ERAS protocols and in patients undergoing colorectal surgery; This will allow, on the one hand, to have a starting point for future clinical trials, and, on the other hand, to focus efforts to avoid these complications.
Aim 3 will allow us to identify those perioperative items of ERAS protocols that are actually associated with a decrease in postoperative complications.
The proposed study will establish a real view of the number of patients presenting postoperative complications that will overcome the limitations of available retrospective studies and provide greater insight into the items of the protocols that are associated with decreased complications; on the other hand, the investigator's hypothesis is that the number of patients who develop predefined postoperative complications within 30 days of surgery decreases as there is greater compliance with the predefined ERAS protocol items
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 861 is above the median of 254 across 519 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →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.
Patients over 18 years of age undergoing gastric resection surgery due to cancer
Exclusion Criteria:
Patients undergoing emergency surgery
Adult patients undergoing elective gastric surgery for cancer
Number of patients with predefined mild-moderate-severe postoperative complications
Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine were published by the EPCO definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome mesures. infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.
Time frame: 30 days after surgery
Number of patients with predefined mild-moderate-severe postoperative complications (gastric cancer surgery specific)
Each complication will be graded as mild, moderate or severe.
Time frame: 30 days after surgery
In-hospital all-cause mortality
The number and percentage of deaths within 30 days of surgery will be reported for each surgical category
Time frame: 30 days after surgery
Compliance with ERAS items
Overall compliance will be calculated as the average of all pre- and intraoperative ERAS adapted elements, as specified in the ERAS society colon and rectal guidelines ERAS patients' guideline compliance will be categorised into quartiles
Time frame: 30 days after surgery
Duration of hospital stay
The median hospital length of stay (LOS) following the start of surgery, overall, by survival status and by complication status will be reported. Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital
Time frame: 30 days after surgery
Plan to share: Undecided
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