Gastric Cancer Clinical Trial
— POWER4Official title:
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER .4)
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.
Status | Not yet recruiting |
Enrollment | 861 |
Est. completion date | March 22, 2020 |
Est. primary completion date | February 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: - Patients undergoing emergency surgery - Endoscopic procedures - Non-oncological gastric surgery - Patients who refuse to participate |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario de A Coruña | A Coruna | Coruña |
Spain | Hospital Universitario Príncipe de Asturias | Alcalá de Henares | Madrid |
Spain | Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid |
Spain | Hospital Virgen de los Lirios de Alcoy | Alcoy | Alicante |
Spain | Hospital General Universitario de Alicante | Alicante | |
Spain | Hospital Universitario de Cruces | Baracaldo | Bizkaia |
Spain | Hospital Clínic Universitat de Barcelona | Barcelona | |
Spain | Hospital Universitario Sant Pau | Barcelona | |
Spain | Hospital Universitario Vall d´Hebrón | Barcelona | |
Spain | Hospital Universitario de Burgos | Burgos | |
Spain | Hospital Universitario Puerta del Mar | Cadiz | Cádiz |
Spain | Hospital General Universitario de Castellón | Castellon de la Plana | Castellón |
Spain | Hospital General Universitario de Ciudad Real | Ciudad Real | |
Spain | Hospital Don Benito-Villanueva de la Serena | Don Benito-Villanueva De La Serena | Badajoz |
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Spain | Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid |
Spain | Hospital Universitario Getafe | Getafe | Madrid |
Spain | Hospital Universitario de Guadalajara | Guadalajara | |
Spain | Hospital de Igualada | Igualada | Barcelona |
Spain | Hospital Comarcal de Inca | Inca | Mallorca |
Spain | Hospital Universitario de Gran Canaria Doctor Negrín | Las Palmas | |
Spain | Hospital Universitario Insular de Gran Canaria | Las Palmas de Gran Canaria | |
Spain | Complejo Asistencial Universitario de León | Leon | León |
Spain | Hospital Universitario Arnau de Vilanova | Lleida | |
Spain | Hospital Rafael Méndez | Lorca | Murcia |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital de La Princesa | Madrid | |
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
Spain | Hospital de Manacor | Manacor | Mallorca |
Spain | Hospital de Manises | Manises | Valencia |
Spain | Hospital Costa del Sol | Marbella | Málaga |
Spain | Hospital de Mérida | Mérida | Badajoz |
Spain | Hospital Rey Juan Carlos | Mostoles | Madrid |
Spain | Hospital Universitario de Móstoles | Mostoles | Madrid |
Spain | Hospital General Universitario José María Morales Messeguer | Murcia | |
Spain | Hospital Reina Sofía | Murcia | |
Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Spain | Complejo Hospitalario y Universitario de Pontevedra | Pontevedra | |
Spain | Hospital Universitario Quirón Madrid | Pozuelo de Alarcon | Madrid |
Spain | Hospital Universitario Parc Tauli | Sabadell | Barcelona |
Spain | Complejo Hospitalario de Salamanca | Salamanca | |
Spain | Hospital de Sant Joan Despí Moisès Broggi | Sant Joan d'Espi | Barcelona |
Spain | Fundación Hospital del Espíritu Santo | Santa Coloma De Gramanet | Barcelona |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | |
Spain | Complejo Asistencial de Segovia | Segovia | |
Spain | Hospital Universitario Virgen de Valme | Sevilla | |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Spain | Hospital Nuestra Señora del Prado | Talavera de la Reina | Toledo |
Spain | Hospital Mútua Terrassa | Terrassa | Barcelona |
Spain | Complejo Hospitalario de Toledo | Toledo | |
Spain | Hospital Universitario de Torrejón | Torrejon de Ardoz | Madrid |
Spain | Hospital Clínico Universitario de Valencia | Valencia | |
Spain | Hospital General Universitario de Valencia | Valencia | |
Spain | Hospital Universitario La Fe | Valencia | |
Spain | Hospital Clínico de Valladolid | Valladolid | |
Spain | Hospital Universitario Río Hortega | Valladolid | |
Spain | Hospital Universitario de Vic | Vic | Barcelona |
Spain | Hospital Comarcal de Vinaroz | Vinaroz | Castellón |
Spain | Hospital Universitario de Álava | Vitoria | |
Spain | Complejo Asistencial de Zamora | Zamora | |
Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Grupo Español de Rehabilitación Multimodal |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | In-hospital all-cause mortality | The number and percentage of deaths within 30 days of surgery will be reported for each surgical category | 30 days after surgery | |
Secondary | 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 | 30 days after surgery | |
Secondary | 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 | 30 days after surgery |
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