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Brief Summary

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.

Outcome Measures

Primary Outcomes (2)

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.
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.
30 days after surgery

Secondary Outcomes (3)

In-hospital all-cause mortality
30 days after surgery
Compliance with ERAS items
30 days after surgery
Duration of hospital stay
30 days after surgery

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients over 18 years of age undergoing gastric resection surgery due to cancer

You may qualify if:

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%).

Study Sites (66)

Hospital Virgen de los Lirios de Alcoy

Alcoy, Alicante, Spain

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital Don Benito-Villanueva de la Serena

Don Benito-Villanueva de La Serena, Badajoz, Spain

Hospital de Mérida

Mérida, Badajoz, Spain

Hospital de Igualada

Igualada, Barcelona, Spain

Hospital Universitario Parc Tauli

Sabadell, Barcelona, Spain

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan d'Espi, Barcelona, Spain

Related Publications (2)

Ripolles-Melchor J, Abad-Motos A, Bruna-Esteban M, Garcia-Nebreda M, Otero-Martinez I, Abdel-Lah Fernandez O, Tormos-Perez MP, Paseiro-Crespo G, Garcia-Alvarez R, A Mayo-Ossorio M, Zugasti-Echarte O, Nespereira-Garcia P, Gil-Gomez L, Logrono-Ejea M, Risco R, Parreno-Manchado FC, Gil-Trujillo S, Benito C, Jerico C, De-Miguel-Cabrera MI, Ugarte-Sierra B, Barragan-Serrano C, Garcia-Erce JA, Munoz-Hernandez H, Rio-Fernandez SD, Herrero-Bogajo ML, Espinosa-Moreno AM, Concepcion-Martin V, Zorrilla-Vaca A, Vaquero-Perez L, Mojarro I, Llacer-Perez M, Gomez-Viana L, Fernandez-Martin MT, Abad-Gurumeta A, Ferrando-Ortola C, Ramirez-Rodriguez JM, Aldecoa C; POWER Study Investigators Group. Association between use of enhanced recovery after surgery protocols and postoperative complications after gastric surgery for cancer (POWER 4): a nationwide, prospective multicentre study. Cir Esp (Engl Ed). 2023 Oct;101(10):665-677. doi: 10.1016/j.cireng.2023.04.011. Epub 2023 Apr 23.

PMID: 37094777DERIVED

Abad-Motos A, Ripolles-Melchor J, Bruna-Esteban M, Ferrando-Ortola C, Paseiro-Crespo G, Abad-Gurumeta A, Garcia-Erce JA, Jerico C, Ramirez JM, Aldecoa C. Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Mar;67(3):130-138. doi: 10.1016/j.redar.2019.10.004. Epub 2019 Nov 22. English, Spanish.

Study Officials

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

Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Gastric Surgery

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Gastric Surgery

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations