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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03865810
Other study ID # REDGERM05
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 22, 2019
Est. completion date March 22, 2020

Study information

Verified date March 2019
Source Grupo Español de Rehabilitación Multimodal
Contact Javier Ripollés-Mellchor
Phone 34 649337762
Email ripo542@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

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

Study Design


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Grupo Español de Rehabilitación Multimodal

Country where clinical trial is conducted

Spain, 

Outcome

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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