Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER4)
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| ClinicalTrials.gov Identifier: NCT03865810 |
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Recruitment Status :
Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 8, 2019
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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.
| Condition or disease |
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| Perioperative Care Postoperative Complications Gastric Cancer |
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
| Study Type : | Observational |
| Estimated Enrollment : | 861 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER .4) |
| Estimated Study Start Date : | October 22, 2019 |
| Estimated Primary Completion Date : | February 22, 2020 |
| Estimated Study Completion Date : | March 22, 2020 |
| Group/Cohort |
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Gastric Surgery
Adult patients undergoing elective gastric surgery for cancer
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- Number of patients with predefined mild-moderate-severe postoperative complications [ Time Frame: 30 days after surgery ]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.
- Number of patients with predefined mild-moderate-severe postoperative complications (gastric cancer surgery specific) [ Time Frame: 30 days after surgery ]Each complication will be graded as mild, moderate or severe.
- In-hospital all-cause mortality [ Time Frame: 30 days after surgery ]The number and percentage of deaths within 30 days of surgery will be reported for each surgical category
- Compliance with ERAS items [ Time Frame: 30 days after surgery ]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
- Duration of hospital stay [ Time Frame: 30 days after surgery ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- All patients over 18 years of age undergoing gastric resection surgery due to cancer within or not of an intensified recovery program (ERAS) with any level of compliance with the protocol (from 0-100%).
Exclusion Criteria:
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Patients undergoing emergency surgery
- Endoscopic procedures
- Non-oncological gastric surgery
- Patients who refuse to participate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865810
| Contact: Javier Ripollés-Mellchor | 34 649337762 | ripo542@gmail.com | |
| Contact: José M Ramírez Rodríguez | 34 649337762 | jramirez@unizar.es |
Show 66 study locations
| Study Chair: | Javier Ripollés-Melchor | Infanta Leonor University Hospital, Madrid, Spain | |
| Study Chair: | Marcos Bruna Esteban | Hospital General Universitario de Valencia, Spain | |
| Study Chair: | José M Ramírez Rodríguez | Lozano Blesa University Hospital, Zaragoza, Spain | |
| Study Chair: | César Aldecoa | Hospital Universitario Río Hortega, Valladolid Spain | |
| Study Chair: | Ane Abad Motos | Infanta Leonor University Hospital, Madrid, Spain | |
| Study Director: | Peter Vorwald | Hospital Universitario Fundación Jiménez Díaz. Madrid, Spain | |
| Study Director: | Gloria Crespo | Infanta Leonor University Hospital, Madrid, Spain | |
| Study Director: | Carlos Ferrando Ortolá | Hospital Clinic of Barcelona | |
| Study Director: | Joaquín Rodríguez Santiago | Hospital Mutua Teresa, Spain | |
| Study Director: | José A García Erce | Servicio Navarro de Salud - Osasunbidea. Pamplona, Spain |
| Responsible Party: | Grupo Español de Rehabilitación Multimodal |
| ClinicalTrials.gov Identifier: | NCT03865810 |
| Other Study ID Numbers: |
REDGERM05 |
| First Posted: | March 7, 2019 Key Record Dates |
| Last Update Posted: | March 8, 2019 |
| Last Verified: | March 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Postoperative Complications Pathologic Processes |