Postoperative Complications Clinical Trial
— POWEROfficial title:
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Lower Gastrointestinal Surgery
NCT number | NCT03012802 |
Other study ID # | GERM01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 15, 2017 |
Est. completion date | March 25, 2018 |
Verified date | January 2019 |
Source | Grupo Español de Rehabilitación Multimodal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Short title POWER Audit
Methods 60 days national (Spain) audit of postoperative complications following elective
gastrointestinal surgery within an enhanced recovery after surgery (ERAS) protocol.
Research sites Hospitals undertaking elective lower gastrointestinal surgery. Objective To
provide detailed data describing post-operative complications and associated mortality; and
length of stay.
To provide detailed data describing adherence to ERAS protocol and its association to
morbidity.
Number of patients Not specified. All eligible patients undergoing surgery during the study
month. Inclusion Criteria All adult patients (aged ≥18 years) undergoing lower
gastrointestinal elective surgery within an ERAS protocol during the 60 day study period.
Statistical analysis Univariate analysis will be used to test factors (patient, surgical, and
ERAS related) associated with surgical complications, length of stay (LOS) and in-hospital
death. Single and multi-level logistic regression models will be constructed to identify
factors independently associated with these outcomes and to adjust for differences in
confounding factors. A stepwise approach will be used to enter new terms. A single final
analysis is planned at the end of the study.
Summary statistics with post hoc Bonferroni corrections will be used to assess possible
dose-response dependence in percentage of patients with postoperative complications and LOS.
Proposed Start Date A 60 day period between 2017
Proposed End Date
Data collection will end by September 2017
Study Duration Six months
Status | Completed |
Enrollment | 2050 |
Est. completion date | March 25, 2018 |
Est. primary completion date | February 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - All adult patients (aged =18 years) undergoing elective lower gastrointestinal surgery within any compliance of an ERAS protocol (including patients with 0 compliance) in a participating hospital during the 60-day cohort period with a planned overnight stay. SURGERY SCHEDULED IN THE INCLUSION CRITERIA - Right hemicolectomy - Resection of transverse colon - Left hemicolectomy - Sigmoidectomy - Low anterior resection of the rectum - Abdominoperineal rectal amputation - Subtotal colectomy - Total colectomy Exclusion Criteria: - Patients undergoing emergency surgery |
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 | OSI Alto Deba | Arrasate-Mondragón | Bilbao |
Spain | Hospital Universitario de Cruces | Baracaldo | Bizkaia |
Spain | Hospital 2 de Mayo | Barcelona | |
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 Jerez de La Frontera | Jerez de La Frontera | Cádiz |
Spain | Hospital Comarcal de Laredo | Laredo | Cantabria |
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 San Pedro | Logroño | La Rioja |
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 Infanta Leonor | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
Spain | Hospital Universitario Virgen del Victoria de Málaga | Malaga | Málaga |
Spain | Hospital de Manacor | Manacor | Mallorca |
Spain | Hospital de Manises | Manises | Valencia |
Spain | Hospital Costa del Sol | Marbella | Málaga |
Spain | Hospital General Mateu Orfila | Menorca | |
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 | Hospital Universitario Son Espases | Palma de Mallorca | Mallorca |
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Spain | Hospital Virgen del Puerto | Plasencia | Cáceres |
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 General de La Palma | Santa Cruz de Tenerife | Tenerife |
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 de Sierrallana | Torrelavega | Santander |
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 | |
Spain | Hospital Royo Vilanova | Zaragoza | |
Spain | Hospital Universitario Miguel Server | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Grupo Español de Rehabilitación Multimodal |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Relationship between ERAS adherence and post- operative complications | To confirm the relationship between ERAS items (according ERAS guidelines) and the predefined postoperative complications. | 30 days | |
Primary | The incidence of 60-day predefined (according EPCO guidelines) postoperative complications following elective lower gastrointestinal surgery within any compliance of an ERAS protocol. | To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery. | 30 days | |
Secondary | 30-day in-hospital mortality associated with these complications | 30 days |
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